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348 essais correspondent à votre recherche

Fiche détaillée de l'essai

Acronyme : "7902-005 NCT03797326 2018-003747-37 MK-7902-005 E7080-G000-224 LEAP-005"
Spécialité : Digestif
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: Pembrolizumab + Lenvatinib

Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) plus lenvatinib 20 mg via oral capsule once a day (QD). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). Lenvatinib will be administered until progressive disease or unacceptable toxicity (up to at least 2 years).

Informations

Tumeurs solides métastatiques, incurables, non réséquables

Cancer du sein triple neg, cancer de l'ovaire, Cancer Gastrique, Cancer colorectal, Glioblastome, Cancer des voies biliairs

Lignes variables selon l'organe

2 places par centre 18/09/2019

TNBC - 25 : 4 slot available

Ovarian - 27 : cohorte closed

Gastric - 23 : 1 slot available

GBM - 23 : 3 slot available

Phase: 2

Promoteur: Merck Sharp & Dohme Corp.

Autre(s) acronyme(s): NCT03797326

2018-003747-37
MK-7902-005
E7080-G000-224
LEAP-005
Contact promoteur: Merck Sharp & Dohme Corp.
Mail promoteur: Trialsites@merck.com
Tel promoteur: 1-888-577-8839


Source: Clinical Trial 2019

Cet essai dans d'autres annuaires :

Détails complémentaires sur l'essai :

Titre :

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)

Critères d'inclusion :
  1. Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer: non-microsatellite instability-High/proficient mismatch repair (MSI-H/pMMR) tumor, GBM, BTC: intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater

  2. Must have progressed on or since the last treatment

  3. Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR

  4. Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated

  5. Male participants agree to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment, and refrain from donating sperm during this period

  6. Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days after the last dose of study treatment

  7. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 7 days of study treatment initiation

  8. Has adequate organ function

    For Triple Negative Breast Cancer Participants:

  9. Has received one or 2 prior lines of therapy

  10. Has Lactate Dehydrogenase (LDH) <2.0 x Upper Limit of Normal (ULN)

    For Ovarian Cancer Participants:

  11. - Has received 3 prior lines of therapy

    For Gastric Cancer Participants:

  12. - Has received 2 prior lines of therapy

    For Colorectal Cancer Participants:

  13. Has received 2 prior lines of therapy

  14. Has a locally determined non-MSI-H/pMMR tumor

    For GBM Participants:

  15. Has failed initial systemic therapy for newly diagnosed GBM

  16. Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines

  17. Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable

  18. Has histologically confirmed World Health Organization (WHO) Grade IV GBM

    For Biliary Tract Cancer Participants:

  19. Has received 1 prior line of therapy

  20. Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6

Critères de non-inclusion :
  1. Has presence of gastrointestinal condition including malabsorption that might affect the absorption of lenvatinib

  2. Radiographic evidence of major blood vessel invasion/infiltration

  3. Clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment

  4. Has significant cardiovascular impairment within 12 months of the first dose of study treatment: such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability

  5. Has a history of arterial thromboembolism within 12 months of start of study treatment

  6. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.

  7. Serious nonhealing wound, ulcer or bone fracture

  8. Biologic response modifiers (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry.

  9. Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])

  10. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 times the half-life time, whichever is shorter prior to study treatment start

  11. If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment

  12. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease

  13. Has received a live vaccine within 30 days prior to the first dose of study treatment

  14. Known intolerance to study treatment (or any of the excipients)

  15. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

  16. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment

  17. Has known active CNS metastases and/or carcinomatous meningitis

  18. Has tumors involving the brain stem

  19. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients

  20. Has an active autoimmune disease that has required systemic treatment in past 2 years

  21. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis

  22. Has an active infection requiring systemic therapy

  23. Has a known history of human immunodeficiency virus (HIV) infection

  24. Has a known history of hepatitis B or known active hepatitis C virus infection

  25. Has a known history of active tuberculosis (TB; Bacillus tuberculosis)

  26. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment

  27. Has had an allogenic tissue/solid organ transplant (large organ transplants, stem-cell transplant requiring chronic immunosuppressant therapy necessary to prevent graft rejection)

    For Colorectal Cancer Participants:

  28. - Has MSI-H/dMMR disease

  29. For GBM Participants:

  30. Has carcinomatous meningitis

  31. Has recurrent tumor greater than 6 cm in maximum diameter

  32. Has tumor primarily localized to the brainstem or spinal cord

  33. Has presence of multifocal tumor, diffuse leptomeningeal or extracranial disease

  34. Has evidence of intratumoral or peritumoral hemorrhage on baseline magnetic resonance imaging (MRI) scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - Institut de Cancérologie de l' Ouest SENELLART Helene - PARERE Adèle - NC / NC Oui 23/08/2019
Afficher les détails
Acronyme : "ADCT-402-103 NCT03684694  2018-002625-38"
Spécialité : Hématologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I
Descriptif

Experimental: ADCT-402
A standard 3+3 dose escalation design will be used. The DLT period will be the 21 days following the first dose of ibrutinib. The initial dose escalation cohort will receive loncastuximab tesirine for 2 cycles with concurrent ibrutinib (concomitant therapy) and may then continue ibrutinib therapy up to one year. Depending on the safety and tolerability of loncastuximab tesirine given concurrently with ibrutinib in the initial cohort, subsequent cohorts may receive either loncastuximab tesirine with concurrent ibrutinib or loncastuximab tesirine followed by ibrutinib (sequential therapy).

Informations

"Phase: 1
Promoteur: ADC Therapeutics
Autre(s) acronyme(s): NCT03684694 
2018-002625-38
Contact promoteur:  ADC Therapeutics
Mail promoteur: 954-903-7994
Tel promoteur: clinical.trials@adctherapeutics.com
Coordonnateur: NR
-
Source: Clinical Trial"

Cet essai dans d'autres annuaires :

Titre :

A Phase 1b Open-Label Study to Evaluate the Safety and Antitumor Activity of Loncastuximab Tesirine and Ibrutinib in Patients With Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma

Critères d'inclusion :
  1. Male or female patient aged 18 years or older

  2. Pathologic diagnosis of DLBCL, non-GCB subtype; or MCL

  3. Patients with DLBCL must have relapsed or refractory disease and have failed or been intolerant to available standard therapy

  4. Patients with MCL must have relapsed or refractory disease and have received at least one prior line of therapy

  5. Patients who have received previous CD19-directed therapy must have a biopsy which shows CD19 expression after completion of the CD19-directed therapy

  6. Measurable disease as defined by the 2014 Lugano Classification

  7. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available)

  8. ECOG performance status 0 to 2

  9. Screening laboratory values within the following parameters:

    Absolute neutrophil count (ANC) ≥1.0 × 103/µL (off growth factors at least 72 hours)

    Platelet count ≥75 × 103/µL without transfusion in the past 7 days

    Hemoglobin ≥8 g/dL (4.96 mmol/L), transfusion allowed

    Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) ≤2.5 × the upper limit of normal (ULN); ≤5 × ULN if there is liver involvement

    Total bilirubin ≤1.5 × ULN (patients with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN)

    Blood creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL/min by the Cockcroft and Gault equation

  10. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drugs on C1D1 for women of childbearing potential

  11. Women of childbearing potential* must agree to use a highly effective** method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of study therapy. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the patient receives his last dose of study therapy

Critères de non-inclusion :
  1. Known history of hypersensitivity to or positive serum human ADA to a CD19 antibody

  2. Known history of hypersensitivity to ibrutinib

  3. Previous therapy with ibrutinib or other BTK inhibitors

  4. Previous therapy with loncastuximab tesirine

  5. Requires treatment or prophylaxis with a moderate or strong cytochrome P450 (CYP) 3A inhibitor

  6. Allogenic or autologous transplant within 60 days prior to start of study drugs (C1D1)

  7. Active graft-versus-host disease

  8. Post-transplantation lymphoproliferative disorder

  9. Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease

  10. Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV).

  11. History of Stevens-Johnson syndrome or toxic epidermal necrolysis

  12. Lymphoma with active CNS involvement at the time of screening, including leptomeningeal disease

  13. Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)

  14. Breastfeeding or pregnant

  15. Significant medical comorbidities, including but not limited to, uncontrolled hypertension (blood pressure [BP] ≥160/100 mmHg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes mellitus, or severe chronic pulmonary disease, or tuberculosis infection (tuberculosis screening based on local standards).

  16. Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy within 14 days prior to start of study drugs (C1D1), except shorter if approved by the Sponsor

  17. Use of any other experimental medication within 14 days prior to start of study drugs (C1D1)

  18. Planned live vaccine administration after starting study drugs (C1D1)

  19. Any condition that could interfere with the absorption or metabolism of ibrutinib including malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel

  20. Inherited or acquired bleeding disorders

  21. Ongoing anticoagulation with warfarin or equivalent vitamin K antagonists

  22. Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) from acute non-hematologic toxicity (Grade ≤2 neuropathy or alopecia) due to previous therapy prior to screening

  23. Congenital long QT syndrome or a corrected QTcF interval of >480 ms at screening (unless secondary to pacemaker or bundle branch block)

  24. Active second primary malignancy other than non-melanoma skin cancers, non metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree, and document should not be exclusionary

  25. Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CLIP² - Damien Denis - damien.denis@chu-rennes.fr NC / NC Oui 31/01/2020
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Pr Roch Houot - UIC - NC / NC Oui 31/01/2020
Afficher les détails
Acronyme : "ALBAN UC-0160/1717 NCT03799835 "
Spécialité : Urologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Active Comparator: Arm A : control arm
BCG therapy only

BCG therapy will be administered in two phases:

induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1)
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).

Experimental: Arm B: experimental arm
BCG therapy + administration of atezolizumab

BCG therapy will be administered in two phases:

induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1)
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).
atezolizumab is administered by IV infusion every 3 weeks (21 [± 2] days) for 1 year (18 cycles as a maximum).

Informations

Cancer de la vessie non infiltrant haut risque, adjuvant

Phase: 3

Promoteur: UNICANCER
Autre(s) acronyme(s): UC-0160/1717
NCT03799835
Contact promoteur: Soazig Nénan-Le Ficher
Maggy Chausson
Mail promoteur: s-nenan@unicancer.fr
m-chausson@unicancer.fr

Tel promoteur: 33185343113
33185343112 ou 33185343112

-
Source: Clinical Trial

Cet essai dans d'autres annuaires :

Titre :

An Open Label, Randomized, Phase III Trial, Evaluating Efficacy of Atezolizumab in Addition to One Year BCG (Bacillus CaLmette-Guerin) Bladder Instillation in BCG-naive Patients With High-risk Non-muscle Invasive Bladder cANcer

Critères d'inclusion :
  1. Signed informed consent form

  2. Adult man and women ( age ≥18 years)

  3. Any high risk non muscle invasive urothelial carcinoma histologically confirmed (mixed histology tumors allowed if urothelial carcinoma histology is predominant) defined on the TURBT as any of the Following :

    T1 tumor and/or

    High grade (G3) and/or

    Carcinoma in situ (CIS)

  4. Tumor tissue available from the surgery for central confirmation of the diagnosis and analysis the expression of PD-L1

  5. At least one additional (second) resection of the primary tumor has been performed in case of T1 tumors, or incomplete initial TURB, or in case of doubt about completeness of a TURB, or if there is no muscle in the specimen (can be omitted if TaLG/G1 tumors or primary CIS only was found) without upstaging towards MIBC (EAU guidelines, 2017)

  6. Absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 42 days prior to the first study treatment

  7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

  8. Life expectancy ≥12 weeks

  9. Systolic blood pressure (BP) <160 mmHg and diastolic BP <95 mmHg, as documented within 7 days prior to the first study treatment (hypertension allowed provided it is controlled)

  10. Adequate hematologic and end-organ function, as defined by the following laboratory results obtained within 7 days prior to the first study treatment:

    absolute neutrophil count (ANC) ≥1500 cells/μL

    white blood cell (WBC) counts >2500/μL

    Lymphocyte count ≥300/μL

    Platelet count ≥100,000/μL

    Hemoglobin ≥9.0 g/dL

    aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), and alkaline phosphatase ≤2.5 × the upper limit of normal (ULN)

    Serum bilirubin ≤1.0 × ULN Patients with known Gilbert disease who have serum bilirubin level ≤3 × ULN may be enrolled.

    Partial thromboplastin time (PTT)/Prothrombin Time (PT) ≤1.5 × ULN or international normalized ratio (INR) <1.7 × ULN

    Calculated creatinine clearance ≥20 mL/min (Cockcroft-Gault formula)

  11. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab

  12. Patients affiliated to the social security system

  13. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up

Critères de non-inclusion :
  1. Patient having received previous BCG therapy for bladder cancer

  2. Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment. Hormone-replacement therapy or oral contraceptives are authorized

  3. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug, whichever is longer, prior to day 1 of study treatment

  4. Malignancies other than urothelial cancer within 5 years prior to Day 1 of cycle 1 of treatment except the following:

    Patients with localized low risk prostate cancer (defined as Stage ≤T2b, Gleason score ≤7, and PSA at prostate cancer diagnosis ≤20 ng/mL [if measured]) treated with curative intent and without prostate-specific antigen (PSA) recurrence are eligible.

    Patients with low risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤7 and PSA ≤10 ng/mL) who are treatment-naive and undergoing active surveillance are eligible.

    Patients with malignancies of a negligible risk of metastasis or death (e.g., risk of metastasis or death <5% at 5 years) are eligible provided they meet all of the following criteria: malignancy treated with expected curative intent (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) and no evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers.

  5. Pregnancy or breastfeeding

  6. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

  7. Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation

  8. History of autoimmune disease or history of immunosuppression, or conditions associated with congenital or acquired immune deficiency , including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see Appendix 6 for a more comprehensive list of autoimmune diseases)

    Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.

    Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.

    History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan may be eligible.

    History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

  9. Serum albumin <2.5 g/dL

  10. Known HIV infection

  11. Patients with known active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen (HBsAg) test at screening) or hepatitis C.

    Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody (HBc Ab) and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to randomisation.

    Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.

  12. Known active tuberculosis

  13. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia

  14. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1

  15. Receipt of therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligible.

  16. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina.

    - Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.

  17. Major surgical procedure other than for diagnosis within 4 weeks prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study

  18. Prior allogeneic stem cell or solid organ transplant

  19. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation if such a live, attenuated vaccine will be required during the study

    - Influenza vaccination should be given during influenza season only (approximately October through May in the Northern Hemisphere and approximately April through September in the Southern Hemisphere). Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1, at randomization, during treatment or within 5 months following the last dose of atezolizumab (for patients randomized to atezolizumab).

  20. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

  21. Prior treatment with CD137 agonists or immune checkpoint−blockade therapies, including anti-CD40, anti−CTLA-4, anti−PD-1, and anti−PD-L1 therapeutic antibodies

  22. Treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin 2 (IL-2)) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1

  23. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial

    Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea, multiple doses for contrast allergy) may be enrolled in the study.

    The use of inhaled or low-dose (e.g., ≤10 mg/day prednisone) corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, mineralocorticoids (e.g., fludrocortisone for adrenal insufficiency) and low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.

  24. Person deprived of their liberty or under protective custody or guardianship

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Pr MATHIEU - UIC - NC / NC Oui 31/01/2020
Plérin - CARIO - HPCA Dr BESSON/Dr CORBEL - - NC / NC Oui 10/10/2019
Afficher les détails
Acronyme : "AMBRE NCT04158362 UC-0140/1901"
Spécialité : Sénologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Standard Chemotherapy regimen
* Paclitaxel: administrated at the dose of 80 mg/m² as a 1-hour intravenous infusion every week (i.e., D1, D8 and D15) of a 3-week cycle.

OR

* Capecitabine: given orally at a dose of 2000 to 2500 mg/m² daily for 14 days followed by a 7-day rest period every 3 weeks.

Interventions:
Drug: Paclitaxel injection
Drug: Capecitabine tablets
Experimental: Standard Endocrine therapy (ET) regimen + Abemaciclib
* Letrozole: continuous orally administration of 2.5 mg/day (1 tablet/day) OR anastrozole continuous orally administration of 1 mg/day (1 tablet/day) in combination with oral abemaciclib 150 mg (BID: twice a day) continuous for patients NSAI naïve or relapsing >1 year after the end of adjuvant ET.

OR

* Fulvestrant: 500 mg intramuscular on D1-D15-D29 (loading dose). Then 500 mg every 28 days (maintenance dose) with oral abemaciclib 150 mg BID continuous for patients relapsing on adjuvant or less than one year after completion of adjuvant NSAI.

For women with a non-menopausal status at inclusion, a concomitant Luteinizing hormone-releasing hormone (LH-RH) agonist will be administered in combination with ET every 28 days. The LH-RH agonist drug to be used will be left to the investigator's choice.

Non-menopausal women will be included as soon as the reimbursement of abemaciclib in combination with ET will be approved for this population.

Interventions:
Drug: Letrozole 2.5mg
Drug: Anastrozole 1mg
Drug: Fulvestrant Prefilled Syringe
Drug: Abemacicli

Informations

Cancer du sein ER+, HER2-

1ère ligne métastatique

Phase: 3

Promoteur: Unicancer
Autre(s) acronyme(s): NCT04158362
UC-0140/1901
Contact promoteur: Cécile VISSAC SABATIER
Mail promoteur: 625155960
Tel promoteur: c-vissac@unicancer.fr


Source: Clinical Trial

Cet essai dans d'autres annuaires :

Titre :

Open-label, randomized, multicenter, phase III study, comparing standard chemotherapy to standard combination of endocrine therapy with abemaciclib as initial metastatic treatment among patients with visceral metastasis of ER+ HER2- breast cancer, high burden disease.

Critères d'inclusion :
  1. Patient must have signed a written informed consent form prior to any study specific procedures.

  2. Female age >18 years.

  3. Performance status, Eastern Cooperative Oncology Group (ECOG) 0-2.

  4. Histologically confirmed adenocarcinoma of the breast.

  5. Metastatic breast cancer, with liver and/or lung and/or pleural and/or peritoneal metastases with high tumor burden (according to RECIST v1.1) defined as either:

  6. visceral involvement of one site with more than 3 lesions,

  7. visceral involvement of at least 2 sites,

  8. symptomatic ascites or pleural effusion, defined as the need for weekly drainage with visceral measurable metastases,

  9. visceral involvement and lactate dehydrogenase (LDH) > Normal value.

  10. Patient considered candidate for a first line chemotherapy in metastatic setting by their physician (either capecitabine or paclitaxel) and who may receive first-line endocrine therapy combined with abemaciclib according to the marketed authorization.

  11. ER-positive by immunohistochemistry (IHC) (>10%) on primary or metastatic disease.

  12. HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish negative.

  13. Non-menopausal women will receive LH-RH agonists at least 1 month before starting the endocrine therapy and every 28 days thereafter.

  14. Adequate renal, hepatic, and hematopoietic functions as defined by the following criteria:

    Absolute Neutrophil Count (ANC) ≥1,500/mm³ or ≥1.5 x 10⁹/L

    Platelets ≥100,000/mm³ or ≥100 x 10⁹/L

    Hemoglobin ≥8 g/dL (patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion).

    Serum Aspartate Transaminase (AST) and serum Alanine Aminotransferase Transaminase (ALT) ≤3 x upper limit of normal (ULN) (<5 ULN if liver metastasis)

    Total serum bilirubin ≤1.5 x ULN (patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted)

    Serum creatinine ≤1.5 x ULN or estimated creatinine clearance >60 mL/min as calculated using the standard method for the institution.

  15. Adequate cardiac functions, including:

  16. 12 Lead electrocardiogram (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention.

  17. QTcF interval ≤480 msec (mean of replicate values, correction per institutional standard)

  18. no history of Torsades de Pointes or other symptomatic corrected QT interval (QTc) abnormality.

  19. Women of childbearing potential agreeing to use highly effective contraception during treatment and for 3 weeks following the last dose of abemaciclib or for 6 months following the last dose of capecitabine or paclitaxel.

  20. Women of childbearing potential must have a negative serum pregnancy test within 7 days and/or urine pregnancy test 48 hours prior to the administration of any study treatment.

  21. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

  22. Health insurance coverage

Critères de non-inclusion :
  1. Bone lesion only or non-measurable lesion (RECIST V1.1).

  2. Patients with all target lesions in a previously irradiated region, except if clear progression has been observed prior to study in at least one of them.

  3. Spinal cord compression and/or symptomatic or progressive brain metastases (Brain metastasis are not acceptable unless asymptomatic or treated and stable off steroids for at least 30 days prior to start of study drug).

  4. Patient with visceral crisis as defined in the 4th ESO-ESMO International Consensus Guidelines (severe organ dysfunction as assessed by signs and symptoms, laboratory studies and rapid progression of disease).

  5. Patient has received one line of chemotherapy for metastatic disease.

  6. Patient has received endocrine therapy for metastatic disease.

  7. Inability to swallow orally administered medication.

  8. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.

  9. Major problem with intestinal absorption.

  10. Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix or the breast, and adequately treated basal cell or squamous cell carcinoma of the skin.

  11. Patient has active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.

  12. Patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.

  13. Patient has any serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30 mL/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).

  14. Any drug or plant derivative that may interact with abemaciclib.

  15. Episode of pulmonary thromboembolism (PTE) in the last six months. Patients with deep vein thrombosis previously treated with a low-molecular-weight heparin for more than two months prior enrolment in the study will be eligible.

  16. Patients with previously documented total/partial dihydropyrimidine dehydrogenase (DPD) deficiency or with DPD deficiency identified at baseline visit (plasma uracil concentration ≥16 ng/mL). These patients will be not eligible for chemotherapy by capecitabine.

  17. Pregnant or breast feeding women.

  18. Patients enrolled in another therapeutic study within 30 days prior inclusion.

  19. Individuals deprived of liberty or placed under the authority of a tutor

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Dr Véronique DIERAS - v.dieras@rennes.unicancer.fr - NC / NC Oui 17/07/2020
Afficher les détails
Acronyme : "ANCHOR-CRC NCT03693170 W00090 GE 2 01 ANCHOR"
Spécialité : Digestif
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: 1 Arm
encorafenib plus binimetinib plus cetuximab

Informations

Cancer colorectal métastatique non traité BRAFV6009 Mutant

1ère ligne

Phase: 2

Promoteur: Pierre Fabre Medicament
Autre(s) acronyme(s): NCT03693170
W00090 GE 2 01
ANCHOR
Contact promoteur: Karim Keddad, MD

Mail promoteur: contact_essais_cliniques@pierre-fabre.com
Tel promoteur: 33534506000
Coordonnateur: Karim Keddad, MD

-
Source: Clinical Trial"

Cet essai dans d'autres annuaires :

Titre :

Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer

Critères d'inclusion :
  1. Male or female ≥ 18 years of age

  2. Histologically or cytologically confirmed CRC that is metastatic

  3. Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening and confirmed by central laboratory

  4. Evidence of measurable disease as per RECIST, v1.1

  5. Subject able to receive cetuximab as per approved label with regards to RAS status

  6. ECOG Status 0 or 1

  7. Adequate renal, hepatic, cardiac and bone marrow functions and adequate electrolytes as per protocol

  8. Subject able to take oral medications

Critères de non-inclusion :
  1. Prior systemic therapy for metastatic disease

  2. Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab or other anti-EGFR inhibitors

  3. Symptomatic brain metastasis or Leptomeningeal disease

  4. History or current evidence of Retinal Vein Occlusion (RVO) or current risk factors for RVO

  5. History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to first dose.

  6. Impaired cardiovascular function or clinically significant cardiovascular diseases: history of myocardial infarction or coronary disorders within 6 months prior to start of study treatment, symptomatic congestive heart failure (grade 2 or higher), past or current clinically significant arrhythmia and/or conduction disorder within 6 months prior to study treatment start

  7. History of thromboembolic or cerebrovascular events within 6 months prior to start of study treatment

  8. Concurrent neuromuscular disorder that is associated with potential elevation of Creatine Kinase

  9. Known contraindication to cetuximab administration as per SPC/approved label

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Brest - CHU de Brest - Site Morvan Pr J. P. Metges - Aurore Cottin - aurore.cottin@chu-brest.fr

02 98 22 32 98

NC / NC Oui 10/09/2019
Afficher les détails
Acronyme : "API-CAT APICAT-Tumeurs solides P170604J NCT03692065 "
Spécialité : Autres
Traitement : Protocole de traitement
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Active Comparator: Apixaban film coated tablets 2.5 mg
Patients randomized in the apixaban reduced dose group will receive an apixaban 2.5 mg tablet and a placebo of apixaban 5 mg tablet, twice daily for 12 months.

Active Comparator: Apixaban film coated tablets 5 mgPatients randomized in the apixaban full dose group will receive a placebo of apixaban 2.5 mg tablet and an apixaban 5 mg tablet, twice daily for 12 months.

 

Informations

Phase: 3

Promoteur: Assistance Publique - Hôpitaux de Paris
Autre(s) acronyme(s): APICAT-Tumeurs solides
P170604J
NCT03692065
Contact promoteur: Isabelle Mahé, Pr
Sofiane DJAILEB, Mr

Mail promoteur: isabelle.mahe@aphp.fr
sofiane.djaileb@aphp.fr
Tel promoteur: 33 (0)1 47 60 64 90
33(0)1 57 27 84 58
Coordonnateur: Guy Meyer, Pr

-
Source: Clinical Trial

Cet essai dans d'autres annuaires :

Détails complémentaires sur l'essai :

Titre :

Long-term Treatment of Cancer Associated VTE: Reduced vs Full Dose of Apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis

Critères d'inclusion :
  1. Signed written informed consent

  2. Any cancer diagnosed histologically (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intra-cerebral metastasis)

  3. Active cancer defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy, hormonotherapy, targeted therapy, immunotherapy at inclusion

  4. Objectively documented index event : Symptomatic or incidental proximal lower-limb, iliac, inferior vena cava DVT or symptomatic or incidental pulmonary embolism in a segmental or larger pulmonary artery or incidental PE in a segmental or larger pulmonary artery

    Proximal DVT is defined as DVT that involves at least the popliteal vein or a more proximal vein, demonstrated by imaging with compression ultrasound (CUS), including grey-scale or color-coded Doppler, or ascending contrast venography or contrast enhanced computed tomography or magnetic resonance imaging

    PE has to be demonstrated by imaging as follows:

    an intraluminal filling defect in segmental or more proximal branches on contrast enhanced chest computed tomography or on computed tomography pulmonary angiography; or

    an intraluminal filling defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram; or

    a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)Incidental VTE is defined as proximal DVT or PE detected by imaging incidentally when a patient undergoes imaging studies as standard of care for the management of his or her malignancy or other reasons but not for a VTE suspicion(e.g. cancer diagnosis or staging).

  5. Completed at least 6 months of anticoagulant therapy at therapeutic dosage (whatever the drug and the dosing),or completed assigned a clinical trial study treatment, for the treatment of the index event and patient still receiving anticoagulant treatment 6 months after occurrence of the VTE index

  6. No objectively documented symptomatic recurrence of VTE between the index event and randomization.

  7. Anticipated duration of anticoagulant treatment of at least 12 months at the time of randomization

  8. Patient affiliated to social security for French centers.

Critères de non-inclusion :
  1. WOCBP who are unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)] to avoid pregnancy for the entire study

  2. Women who are pregnant or breastfeeding

  3. Women with a positive pregnancy test on enrollment or prior to investigational product administration

  4. Isolated sub-segmental (incidental or symptomatic) PE without associated DVT

  5. Isolated distal DVT of the legs

  6. Isolated upper-extremity DVT or superior vena cava thrombosis

  7. Isolated visceral thrombosis

  8. Isolated catheter thrombosis

  9. Objectively documented symptomatic recurrence of VTE after the index event under anticoagulant treatment

  10. VTE during anticoagulant treatment given at therapeutic dosage

  11. Subjects with indications for long-term treatment with a VKA, such as:

  12. Mechanical heart valve

  13. Antiphospholipid syndrome

  14. Subjects with indication for long-term anticoagulation with a VKA or a DOAC at therapeutic dosage

  15. Conditions increasing the risk of serious bleeding

    intracranial or intraocular bleeding within the 6 months

    major surgery within 2 weeks prior to randomization

    overt major bleeding at time of randomization

  16. Life expectancy < 12 months

  17. Eastern Cooperative Oncology Group (ECOG) level 3 or 4

  18. Bacterial endocarditis

  19. Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg

  20. Platelet count < 75,000/mm3

  21. Hemoglobin < 8g /dl

  22. Creatinine clearance < 30 ml /min based on the Cockcroft Gault equation

  23. Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range

  24. Subjects requiring acetylsalicylic acid >165 mg/day at randomization or thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor).

  25. Subjects requiring dual anti-platelet therapy (such as acetylsalicylic acid plus clopidogrel or acetylsalicylic acid plus ticlopidine) at randomization. Subjects who transition from dual antiplatelet therapy to monotherapy prior to randomization will be eligible for the trial.

  26. Concomitant use of strong inhibitors of both cytochrome P-450 3A4 and P Glycoprotein (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole) or strong inducers of both cytochrome P450 3A4 and P Glycoprotein (e.g.,rifampicin, carbamazepine, or phenytoin).

  27. Prisoners or subjects who are involuntarily incarcerated

  28. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

  29. Hypersensitivity to apixaban

  30. Subjects participating in another pharmaco therapeutic program with an experimental therapy that is known to affect the coagulation system

  31. Under 18 years old

  32. Patients under legal protection (guardianship).

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Dr Bettina BOUTRUCHE - Véronique BRIEUC - v.brieuc@rennes.unicancer.fr NC / NC Oui 23/08/2019
Afficher les détails
Acronyme : "BETTER 2 NCT03351296 2017-000741-46 2017/2523"
Spécialité : Digestif
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: LV5FU2 + streptozotocin +/- Bevacizumab

Experimental: Capecitabine + temozolomide +/- Bevacizumab


Informations

Tumeur neuro-endocrine pancréatique bien différenciée

Lignes 1-2-3

Phase: 2

Promoteur: IGR
Autre(s) acronyme(s): NCT03351296
2017-000741-46
2017/2523
Contact promoteur: Michel Ducreux, MD, PhD
Merce Guzman Vendrell
Mail promoteur: 0142116017 ext +33
0142116643 ext +33
Tel promoteur: michel.ducreux@gustaveroussy.fr
merce.guzman-vendrell@gustaveroussy.fr

-
Source: Clinical Trial"

Cet essai dans d'autres annuaires :

Titre :

Randomized Phase 2 Trial Of Two Chemotherapy Regimens Plus Or Minus Bevacizumab In Patients With Well Differentiated Pancreatic Neuroendocrine Tumors

Critères d'inclusion :
  1. Well differentiated pancreatic neuroendocrine tumor grade 1 (NET G1) or grade 2 (NET G2) or grade 3 (NET G3)

  2. Indication for chemotherapy for locally advanced or metastatic disease with proven progression (at least 20% increase of tumor size on a maximum 12 months period of follow-up) or other indication of chemotherapy following the National Thesaurus of GI Cancerology (Appendix 6) (liver involvement > 50%, symptoms related to the tumour or its metastases, Ki67>10%) (Appendix 6)

  3. Patient with at least one measurable target tumor by RECIST 1.1 that thas never been irradiated

  4. Patient with a life expectancy greater than 3 months

  5. Men or women with performance status (ECOG) ≤ 2

  6. Age ≥ 18 years

  7. Adequate hematological function: neutrophil count (ANC) ≥ 1,5x109/L, platelets >/= 75x109/L, hemoglobin >/= 10g/dl (blood transfusions are accepted to reach this level).

  8. Adequate liver function: serum bilirubin </= 3 x upper limit of normal (ULN); aminotransferases and alkaline phosphatase levels </= 2.5 ULN (</= 5 ULN if liver metastases), TP > 50%

  9. Proteinuria ≤ 1g/24 h, blood creatinine less than 120 μmol/L and creatinin clearance ≥ 60 ml/min as calculated by Cockroft-Gault formula Note: a negative dipstick urine analysis is sufficient.

  10. Absence of active bleeding, coagulopathy or pathologic condition that would confer a high risk of bleeding

  11. Prior treatment with somatostatin analogues, everolimus or sunitinib is allowed

  12. Negative serum pregnancy test ≤ 72 hours before randomization (for women of childbearing potential only). Sexually active women of childbearing potential must agree to use a highly effective method of contraception or to abstain from sexual activity during the study and for at least 6 months after the last study treatment administration. Sexually active males patients must agree to use condom during the study and for at least 6 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.

  13. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.

  14. Patient affiliated to a social security regimen or beneficiary of such regimen

Critères de non-inclusion :
  1. Disease accessible to resection or percutaneous method of destruction

  2. Any known allergy or contraindication to the treatments used in the trial, 2.1 Patients with a complete DPD deficiency; defined as an uracil concentration ≥150ng/ml Note: patients with a suspicion of partial DPD deficiency, defined as a uracil concentration ≥ 16 ng/ml and < 150 ng/ml, will receive an adapted 1st cycle dose, according to a clinic-biological discussion. The dose can be then readapted for the second cycle according to the tolerability of the treatment during the 1st cycle.

  3. Patient previously treated with chemotherapy for the neuroendocrine tumour

  4. Patient have received any other antitumor therapy: chemotherapy, immunotherapy

  5. Other serious diseases such as respiratory failure or congestive heart failure, angina pectoris not medically controlled. History of myocardial infarction, within 6 months prior to study entry, uncontrolled hypertension and arrhythmias, concomitant severe infection or uncontrolled diabetes mellitus.

  6. Subjects with a history of chronic or acute hepatitis C or B infection.

  7. Surgery during the 5 weeks preceding the randomization

  8. History of cancer (except basal cell skin or carcinoma in situ carcinoma of the cervix) within 5 years prior to entry into the trial. But patients with cancers that have been treated more than 5 years ago and are considered as cured are eligible.

  9. Neurological or psychiatric pathology that may interfere with adherence to treatment

  10. Patients have received yellow fever vaccine within 30 days prior to the first dose of trial treatment.

  11. Patient with pernicious anaemia and other megaloblastic anaemias secondary to the lack of Vitamin B12

  12. Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies

  13. Hypersensitivity to study drugs or any of its excipients

  14. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

  15. Pregnant or breast feeding women

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Dr Marc Pracht - Lucile MORVAN - NC / NC Oui 20/07/2020
Afficher les détails
Acronyme : "BEVAMAINT PRODIGE 71 NCT04188145"
Spécialité : Digestif
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Active Comparator: Fluoropyrimidine
Intervention: Drug: Fluoropyrimidine
Active Comparator: Fluoropyrimidine + Bevacizumab

Informations

Cancer colo-rectal métastatique

2ème ligne et +

Phase: 3

Promoteur: Centre Hospitalier Universitaire Dijon
Autre(s) acronyme(s): PRODIGE 71
NCT04188145
Contact promoteur: Thomas Aparicio
Mail promoteur: (0)1 42 49 95 97 ext +33
Tel promoteur: (0)1 42 49 95 97 ext +33 thomas.aparicio@aphp.fr


-
Source: Clinical Trial"

Cet essai dans d'autres annuaires :

Titre :

A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer

Critères d'inclusion :
  1. "Histologically confirmed metastatic colorectal adenocarcinoma before induction treatment

  2. Measurable or non-measurable lesion before the induction treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  3. Metastatic, unresectable disease according local practice after induction treatment

  4. ECOG performance status ≤ 2

  5. Disease control (complete response, partial response or stable disease) after 4-6 months of frontline induction chemotherapy with doublet (fluoropyrimidine + irinotecan or oxaliplatin) or triplet (fluoropyrimidine + irinotecan + oxaliplatin) +/- (cetuximab, panitumumab, bevacizumab) or IAH chemotherapy

  6. Life expectancy > 3 months

  7. Age ≥ 18 years

  8. Patient is at least 4 weeks from any major surgery

  9. Total bilirubin < 25 µmol/L, ASAT < 3 x ULN, ALAT < 3 x ULN (ASAT , ALAT < 5 x ULN in case of hepatic metastasis) , PT >60% , PAL<2.5 x ULN ( < 5 x ULN in case of hepatic metastasis) - Neutrophils > 1500/mm3, platelets > 100 000/mm3, haemoglobin ≥ 9 g/dL

  10. Creatinin clearance > 30 ml/min (MDRD) - if creatinin clearance comprised between 30 and 50 ml/min, see smPCs for dose adjustments

  11. Proteinuria ≤ 2+ (dipstick urinalysis) (if more than 2+, so proteinuria at or ≤1g/24hour must be ≤1g)

  12. Patient is able to understand, sign, and date the written informed consent

  13. Evidence of post-menopausal status or negative urinary or serum pregnancy test for premenopausal female patients

  14. Male and female patients of childbearing potential agree to use a highly effective contraceptive measure

  15. Patient affiliated to a social security system"

Critères de non-inclusion :
  1. "Myocardial infarction, severe coronaropathy or severe cardiac dysfunction less than 6 months prior randomization

  2. Follow-up impossible

  3. Patients with all metastases resected (R0/R1) after induction chemotherapy

  4. Patient with a hand-foot syndrome > 1 before maintenance treatment

  5. Known brain or leptomeningeal metastases

  6. Other concomitant or previous malignancy, except: adequately treated in situ carcinoma in complete remission for > 5 years

  7. Uncontrolled hypertension (defined as systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy

  8. Pregnancy or breast feeding

  9. Treatment with sorivudine or analogs (brivudine)

  10. Treatment with phenytoin or analogs

  11. Partial or complete DPD deficiency (Uracilemia ≥ 16 ng/ml)

  12. Peptic ulcer not healed after treatment

  13. Any contraindication to bevacizumab or fluoropyrimidine treatments according to the updated SmPC

  14. Intestinal perforation or intestinal fistula

  15. Previous or active gastrointestinal bleeding

  16. Thromboembolic event and/or history of thromboembolic event

  17. Severe hepatic insufficiency"

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Vannes - Centre Hospitalier Bretagne Atlantique Dr RABILLOUD - JOUMARD Céline - / Oui 04/09/2020
Afficher les détails
Acronyme : "BI12800.18 1280.18 NCT03099174 ""BI12800.18 1280.18 NCT03099174 "
Spécialité : Gynécologie - Sénologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I
Descriptif

Experimental: Cohort A
Xentuzumab + Abemaciclib (Dose 1)

Experimental: Cohort B
Xentuzumab + Abemaciclib + Letrozole (Dose 2)

Experimental: Cohort C
Xentuzumab + Abemaciclib + Anastrozole (Dose 3)

Experimental: Cohort D
Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)

Experimental: Cohort E
Xentuzumab + Abemaciclib (Dose 1)

Experimental: Cohort F
Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)

Experimental: Cohort D1
Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)

Experimental: Cohort D2
Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)

Informations

 

Cancer du sein, avancé, métastatique

 

Phase: 1

Promoteur: Boehringer Ingelheim
Autre(s) acronyme(s): 1280.18
NCT03099174

Contact promoteur: Boehringer Ingelheim Call Center
Mail promoteur: clintriage.rdg@boehringer-ingelheim.com
Tel promoteur: 1-800-243-0127
-
Source: Clinical Trial

Cet essai dans d'autres annuaires :

Titre :

An Open Label, Phase Ib, Dose-escalation Study Evaluating the Safety and Tolerability of Xentuzumab and Abemaciclib in Patients With Locally Advanced or Metastatic Solid Tumours and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-positive, HER2-, Breast Cancer, Followed by Expansion Cohorts.

Critères d'inclusion :

Cohort A (Solid Tumours)

  1. Age >= 18 years (>=20 years for Japan only) at screening

  2. Signed and dated written informed consent in accordance with GCP (Good Clinical Practice and local legislation prior to admission to the trial

  3. WHO/ECOG (World Health Organization / Eastern Cooperative Oncology Group) performance status 0-1 assessed at screening

  4. Patient must be able to swallow oral capsules.

  5. Male or female patients ready and able to use highly effective methods of birth control during the study and for 3 weeks following the last dose of abemaciclib per ICH (International Conference on Harmonization) M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. Women of childbearing potential must have a negative serum pregnancy test at screening.

  6. Patients with histologically or cytologically confirmed diagnosis of advanced and/or metastatic, measurable or evaluable, non-resectable solid tumours

  7. Patients must have received and failed, or have been intolerant to, all treatment known to confer clinical benefit or have no therapeutic options available as deemed appropriate by their treating physician

  8. Life expectancy >= 3 months in the opinion of the investigator assessed at screening;

Cohorts B, C, D, F (Breast Cancer):

  1. Age >= 18 years (>=20 years for Japan only) at screening

  2. Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial

  3. WHO/ECOG performance status 0-1 assessed at screening

  4. Patient must be able to swallow oral capsules.

  5. Women who have postmenopausal status due to either surgical/natural menopause or chemical ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin or radiation-induced ovarian suppression.

  6. postmenopausal status due to surgical/natural menopause requires at least one of the following conditions:

  7. prior bilateral oophorectomy

  8. age ≥ 60 years

  9. age < 60 years and amenorrheic (in the absence of tamoxifen,toremifene, ovarian suppression, or chemotherapy) for at least 12 months; and follicle-stimulating hormone (FSH) and estradiol within the postmenopausal range as per institutional reference ranges.

  10. Postmenopausal status due to radiation-induced ovarian suppression must be confirmed by FSH and estradiol level in the postmenopausal range

  11. Histologically or cytologically proven diagnosis of breast cancer with evidence of locally advanced disease not amenable to curative resection or metastatic disease

  12. HR+ (local lab results at screening or, if not available, at the time of diagnosis) To fulfil the requirement of HR+ disease, the primary tumour or metastatic lesion of the breast cancer must express at least one of the hormone receptors (estrogen receptor [ER] or progesterone receptor [PgR]) by immunohistochemistry (IHC). Estrogen receptor and PgR assays are considered positive if there are at least 1% positive tumour nuclei in the sample as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines (Hammond et al. 2010).

  13. HER2 negative (local lab results at screening or, if not available, at the time of diagnosis) as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines (Hammond et al. 2010).

  14. Previous adjuvant and neoadjuvant chemotherapy is permitted. 0-2 prior lines of chemotherapy for the metastatic setting are allowed.

  15. At least 1 lesion (measurable or non-measurable) that can be accurately assessed at baseline with CT or MRI or PET-CT (CT portion of diagnostic quality) and which is suitable for accurate repeated measurement. For Cohort F only: patients should have at least one measurable lesion.

Cohort B, C, D, F Must be eligible for the corresponding hormonal therapy (letrozole, anastrozole or fulvestrant). For Cohorts B and C previous treatment with fulvestrant or exemestane is allowed. For Cohort D and F prior therapy with non steroidal aromatase inhibitors (anastrozole, letrozole) or exemestane are permitted

Cohort F only: Postmenopausal with locally advanced or metastatic HR+ breast cancer and refractory to aromatase inhibitors therapy and CDK4/6 inhibitor treatment (e.g., palbociclib or ribociclib) for locally advanced or metastatic breast cancer.Resistance to aromatase inhibitors therapy is defined as the following:

  1. disease recurrence while on, or within 12 months of end of adjuvant treatment with letrozole, anastrozole, or exemestane;

  2. or disease progression while on, or within one month of end of letrozole, anastrozole, or exemestane.

  3. Cohort E (NSCLC (Non-Small Cell Lung Cancer)):

  4. Age >= 18 years (>=20 years for Japan only) at screening

  5. Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial

  6. WHO/ECOG performance status 0-1 assessed at screening

  7. Patient must be able to swallow oral capsules.

  8. Male or female patients ready and able to use highly effective methods of birth control during the study and for 12 weeks following the last dose of abemaciclib per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. Women of childbearing potential must have a negative serum pregnancy test at screening.

  9. Histologically or cytologically confirmed diagnosis of stage IV NSCLC.

  10. The participant must have progressed after platinum-based chemotherapy AND immunotherapy (unless deemed inappropriate candidates for immunotherapy by their treating physician) AND have received a maximum of 2 other prior chemotherapy for advanced and/or metastatic disease OR must be judged by the physician as ineligible for further standard second-line chemotherapy. Prior treatment with epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) and anaplastic lymphoma kinase (ALK) inhibitors is mandatory in participants whose tumour has EGFR-activating mutations or ALK translocations. Prior targeting agents and neoadjuvant/adjuvant therapies are permitted.

  11. Have adequate organ function including haematology, renal, and liver.

  12. Have measureable disease per Response Evaluation Criteria In Solid Tumours (RECIST) 1.1.

  13. Further inclusion criteria apply

Critères de non-inclusion :
  1. Cohorts A, B, C, D (dose finding), E and F:

  2. Any documented active or suspected malignancy or history of malignancy, other than the disease under study, within 3 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix or ductal carcinoma in situ (DCIS) if properly treated in opinion of the investigator.

  3. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial

  4. Previous treatment in this trial

  5. Currently enrolled in another investigational device or drug study, or less than 21 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s).

  6. Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable study subject or unlikely to complete the trial

  7. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Men who plan to father a child while in the trial.

  8. Prior anti-cancer chemotherapy, biological or radiation therapy, androgens, thalidomide, other anticancer agents, or any investigational drug within 21 days (14 days for nonmyelosuppressive agents); and/or 4 weeks for immunotherapy, before starting any of the trial drugs.

  9. Prior anti CDK (Cyclin-dependent Kinase) agents (except cohort F)

  10. Prior radiotherapy to >= 25% of bone marrow regardless of when it was received

  11. Unresolved treatment related toxicity from previous therapy of > CTCAE grade 1 at study entry (except for stable sensory neuropathy ≤ CTCAE grade 2 and alopecia)

  12. Previous treatment with IGF (Insulin-like Growth Factor)-1R targeting compounds

  13. Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease, as indicated by clinical symptoms, cerebral oedema, and/or progressive growth. History of CNS metastases or cord compression are eligible if they have been definitively treated (e.g. radiotherapy, stereotactic surgery) and are clinically stable, off anticonvulsants and steroids for at least 4 weeks. Patients with brain metastases are eligible if they are asymptomatic, completed radiotherapy for at least 4 weeks or are on a stable dose of steroids for at least 4 weeks. Patients are not eligible if they have spinal cord compression.

  14. Any evidence of severe or uncontrolled systemic disease as judged by the Investigator.

  15. Inadequate bone marrow reserve or organ function as demonstrated by any of the following: ANC < 1.5 x 109/L, platelets < 100 x 109/L, haemoglobin <90g/L, ALT > 2.5 x ULN or > 5 x ULN in the presence of liver metastases, total bilirubin >1.5 x ULN or >3 x ULN in patients with Gilbert's Syndrome, serum creatinine > 1.5 x ULN concurrent with creatinine clearance <= 50 mL/min.

  16. Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis

  17. Refractory nausea and vomiting, chronic GI diseases, inability to swallow the product, or previous significant bowel resection that would preclude adequate absorption of abemaciclib or resulting in baseline Grade 2 or higher diarrhoea.

  18. History of hypersensitivity to active or inactive excipients of xentuzumab, abemaciclib or letrozole/anastrozole/fulvestrant, or loperamide hydrochloride, or drugs with similar chemical structures

  19. Patients with Diabetes Type I or uncontrolled Type II (defined by HgBA1C > 8%)

  20. Patients with advanced/metastatic, symptomatic, visceral spread, that are at risk of life threatening complications in the short term including patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and over 50% of liver involvement in metastases.

  21. Prior hematopoietic stem cell or bone marrow transplant

  22. Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Subjects with controlled atrial fibrillation for >30 days prior to study treatment are eligible.

  23. Erythropoietin, G-CSF, and GM-CSF are not allowed within 2 weeks prior to study. The primary prophylactic use of G-CSF is not permitted but it may be used to treat treatment emergent neutropenia.

  24. Have had major surgery (excluding biopsy) < 28 days of the initial dose of any of the study drugs or planned major surgery during study participation.

  25. Have active bacterial or fungal infection (that is, requiring IV antibiotics or therapy at time of initiating study treatment), and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen, or hepatitis C antibodies). Screening is not required for enrolment.

  26. Patients with baseline Grade >=2 hyperglycaemia or patients with baseline Grade >= 2 diarrhoea

  27. Patients needing treatment with CYP3A4 inhibitors/inducers cannot be included in the trial.

  28. Further exclusion criteria apply

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - Aude Vincent - a.vincent@bec22.fr NC / NC Oui 02/10/2019
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Acronyme : "BP41054 2018-003872-11 NCT03875079"
Spécialité : Dermatologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I
Descriptif

Experimental: Part I Safety Run in: RO6874281 + Pembrolizumab
Cohort 1.1 (CPI naive and experienced melanoma participants):

Participants will receive RO6874281 in combination with Pembrolizumab every 3 weeks (Q3W) and will be observed for 2 cycles (ie: 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part II of this study.

Cohort 1.2 (CPI experienced melanoma participants only):

Participants will receive RO6874281 in combination with Pembrolizumab via an induction and maintenance schedule for RO6874281: QW three times (D1, D8, D15) followed by Q3W dosing (D22 and subsequent). Pembrolizumab is to be administered Q3W, starting on Day 1. Participants will be observed for 2 pembrolizumab cycles (ie: 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part III of this study.


Experimental: Part II Expansion: RO6874281 + Pembrolizumab
Part II will start once all participants in Part I Cohort 1.1 have completed the observation period. Approximately 34 participants will receive RO6874281 in combination with Pembrolizumab every 3 weeks (Q3W) and will be observed for 2 cycles (ie: 6 weeks).

Experimental: Part III Expansion: RO6874281 + Pembrolizumab
Part III will start once all participants in Part I Cohorts 1.1 and 1.2 have completed the observation period. Approximately 80 participants will be randomised to receive RO6874281 in combination with Pembrolizumab in either a Q3W or QW/Q3W schedule.

Informations

Mélanome avancé, inopérable, BRAF connu

1ère ligne et 2ème ligne

 

Phase: 1

Promoteur: Hoffmann-La Roche
Autre(s) acronyme(s): 2018-003872-11
NCT03875079
Contact promoteur: 888-662-6728 (U.S. and Canada
Mail promoteur : global-roche-genentech-trials@gene.com
Source: Clinical Trial"

Cet essai dans d'autres annuaires :

Titre :

An Open-Label, Multicenter, Phase Ib Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), In Combination With Pembrolizumab (Anti-PD-1), In Participants With Advanced Or Metastatic Melanoma

Critères d'inclusion :
  1. Histologically confirmed unresectable stage III or stage IV cutaneous or mucosal melanoma (AJCC v8.0).

  2. Participants need to have known BRAF status.

  3. CPI naïve melanoma population: Participants with unresectable stage III or stage IV cutaneous or mucosal melanoma who have not received prior treatment for advanced disease. BRAF mutation-positive patients are eligible without prior treatment or after failure of BRAF directed inhibitor therapy.

  4. CPI experienced melanoma population: Participants with unresectable stage III or stage IV cutaneous melanoma. Participants must have progressed during or after treatment with anti PD-1 antibody therapy, either as monotherapy or in combination with other agent(s).

  5. Participants should have adequate cardiovascular, hematological, liver, and renal function.

  6. Participants with unilateral pleural effusion are eligible if they fulfill both of the following: NYHA Class 1; Forced expiratory volume 1 (FEV1) >70% and forced vital capacity (FVC) >70% of predicted value; participants with lung metastases should present with DLCO >60% of predicted value.

Critères de non-inclusion :
  1. Rapid disease progression or suspected hyperprogression (as determined by the Investigator) or threat to vital organs or critical anatomical sites requiring urgent alternative medical intervention.

  2. Known active CNS metastases and/or carcinomatous meningitis/leptomeningeal disease:

    Participants with previously treated brain metastases may participate.

  3. History of treated asymptomatic CNS metastases.

  4. An active second malignancy (exceptions are non-melanoma skin cancer, cervical carcinoma in situ, or prostate carcinoma that is in remission under androgen deprivation therapy for ≥ 2 years, or participants who have a history of malignancy and have been treated with curative intent and the participant is expected to be cured as per Investigator's assessment).

  5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, and known autoimmune diseases or other disease with ongoing fibrosis (such as scleroderma, pulmonary fibrosis. and emphysema).

  6. Episode of significant cardiovascular/cerebrovascular acute disease within 6 months before study treatment administration.

  7. Active or uncontrolled infections, including latent tuberculosis.

  8. Known HIV infection.

  9. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

  10. Severe infection within 4 weeks before study treatment administration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.

  11. History of chronic liver disease or evidence of hepatic cirrhosis.

  12. Dementia or altered mental status that would prohibit informed consent.

  13. History of autoimmune disease.

  14. Adverse events related to any previous radiotherapy, chemotherapy, targeted therapy, CPI therapy or surgical procedure that have not resolved to Grade =< 1, except alopecia (any grade) and Grade 2 peripheral neuropathy.

  15. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan.

  16. Bilateral pleural effusion.

  17. Severe dyspnea at rest or requiring supplementary oxygen therapy.

  18. Concurrent therapy with any other investigational drug (defined as a treatment for which there is currently no regulatory authority approved indication).

  19. Immunomodulating agents: Last dose with any of the following agents, for example, etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept, or efalizumab (or similar agents) < 28 days before study treatment administration. Regular immunosuppressive therapy (i.e., for organ transplantation, chronic rheumatologic disease)

  20. Treatment with systemic immunosuppressive medications including, but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents within 2 weeks prior to Cycle 1 Day 1.

  21. Radiotherapy within the last 4 weeks before start of study treatment administration, with the exception of limited field palliative radiotherapy.

  22. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.

  23. Major surgery or significant traumatic injury < 28 days before study treatment administration (excluding fine needle biopsies) or anticipation of the need for major surgery during study treatment.

  24. Known hypersensitivity to any of the components of the RO6874281 drug product or pembrolizumab drug product, including but not limited to hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.

  25. No prior cytotoxic therapy for unresectable stage III or stage IV disease is permitted.

  26. Toxicity from prior anti-PD-1 antibody therapy (including adjuvant treatment)

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CLIP² Dr Thierry Lesimple - Damien Denis - damien.denis@chu-rennes.fr NC / NC Oui 12/05/2020
Rennes - Centre Eugène Marquis Dr Thierry Lesimple - - NC / NC Oui 12/05/2020
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