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362 essais correspondent à votre recherche

Fiche détaillée de l'essai

Acronyme : " COMBO D5330C00004"
Spécialité : Digestif
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase Ia, Phase Ib
Descriptif

Experimental: Module 1 Part A
Module 1 Part A: ascending doses of AZD6738 in combination with carboplatin AUC5 will be administered to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD).
Intervention: Drug: Administration of AZD6738 in combination with carboplatin

Experimental: Module 1 Part B
Module 1 Part B: patients with advanced lung adenocarcinoma with low expression of ATM will receive AZD6738 and carboplatin, at the dose, frequency and schedule recommended from Module 1 Part A.
Intervention: Drug: Administration of AZD6738 in combination with carboplatin

Experimental: Module 2 Part A1
Module 2 Part A1: ascending doses of AZD6738 will be administered alone to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD) to take into Module 2 Part A2.
Intervention: Drug: Administration of AZD6738

Experimental: Module 2 Part A2
Module 2 Part A2: ascending doses of AZD6738 will be administered in combination with olaparib to patients to define the dose, frequency and schedule of AZD6738 and olaparib to take into Module 2 Part B.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B1
Module 2 Part B1: Patients with second line 'ATM deficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B2
Module 2 part B2: Patients with second line 'ATM proficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B3
Module 2 Part B3: Patient with second or third line breast cancer with BRCA mutations (somatic or germline), excluding HER2 positive breast cancer will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B4
Module Part B4: Patients with second or third line triple negative breast cancer with no known BRCA mutations. This expansion will be enriched for patients with disease harbouring a HRR-related gene mutation (HRRm) will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 3 Part A
Module 3 Part A: cohort escalation of AZD6738 in combination with MEDI4736 in HNSCC or NSCLC patients to define the dose, frequency and schedule of AZD6738 and MEDI4736 to take into Module 3 Part B.
Intervention: Drug: Administation of AZD6738 in combination with MEDI4736

Experimental: Module 3 Part B
Module 3 Part B: cohort expansions of AZD6738 in combination with MEDI4736 in HNSCC or NSCLC patients at dose, frequency and schedule from Module 3 Part A.
Intervention: Drug: Administation of AZD6738 in combination with MEDI4736

Informations

ATM deficient, ATM proficient, HER2 negative, Breast, Gastric, Head & Neck, Lung

cancer métastatique

ligne de traitement variable selon les organes

 

12/12/2018
B3 : cancer du sein HER2 négatif avec mutation BRCA1 ou BRCA2 somatique ou germinale, en 2ème et 3ème ligne : Fermé
B4 : cancer du sein triple négatif sans mutation BRCA1 ou BRAC2 identifiée, en 2ème ou 3ème ligne : Ouvert

 

Phase: 1,1b,

Promoteur: AstraZeneca
Autre(s) acronyme(s): D5330C00004
Contact promoteur: AstraZeneca Clinical Study Information Center
AstraZeneca Cancer Study Locator Service

-
Source: Clinical trials.gov le 02/08/2018"

Cet essai dans d'autres annuaires :

Titre :

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies

Critères d'inclusion :
  1. "Aged at least 18

  2. The presence of a solid malignant tumour that is not considered appropriate for further standard treatment

  3. Module 1 and 2 Part B study expansions, and Module 3: patients must have a tumour at least 1 cm in size that can be measured using a CT or MRI scan

  4. Module 1 Part B Study expansion: second line lung adenocarcinoma with ATM deficient tumours.

  5. Module 2 Part B All - No previous treatment with PARP inhibitor.

  6. Module 2 Part B1 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM deficient tumours

  7. Module 2 Part B2 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM proficient tumours

  8. Module2 Part B3 Study expansion: Second or thrid line HER2 negative breast cancer

  9. Module 2 Part B4 Study expansion: Second or third line triple negative breast cancer (TNBC) Module 3: advanced recurrent or metastatic non-small cell lung cancer, or head and neck squamous cell carcinoma"

Critères de non-inclusion :
  1. "A diagnosis of ataxia telangiectasia

  2. Prior exposure to an ATR inhibitor

  3. Bad reaction to AZD6738

  4. Module 1: Contra-indicated for treatment with carboplatin

  5. Module 2: Contra-indicated for treatment with olaparib

  6. Module 3: Contra-indicated for treatment with MEDI4736"

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 Dr CAMPONE Mario - - / Oui 11/09/2018
Afficher les détails
Acronyme : "2017-A02058-45 PHRC-K16-164 STEREOPOSTOP"
Spécialité : ORL
Traitement : Traitement adjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: postoperative SBRT
SBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days
Intervention: Radiation: postoperative hypofractionated stereotactic radiotherapy

Informations

Carcinome épidermoide, stade 1, stade 2

Oropharynx, cavité buccale

Adjuvant

Phase: 2

Promoteur: Centre Jean Perrin
Autre(s) acronyme(s): PHRC-K16-164
STEREOPOSTOP
Contact promoteur: Julian BIAU
Mail promoteur: julian.biau@clermont.unicancer.fr
Tel promoteur: 33473278089

-
Source: Clinical Trial 2019

Cet essai dans d'autres annuaires :

Titre :

A Multicenter Prospective Phase II Study of Postoperative Hypofractionated Stereotactic Body Radiotherapy (SBRT) in the Treatment of Early Stage Oropharyngeal and Oral Cavity Cancers With High Risk Margins

Critères d'inclusion :
  1. Operated squamous cell carcinoma of oral cavity (lips excepted) or oropharynx

  2. pT1 or pT2 ((UICC 7th edition 2009)

  3. Indication of postoperative tumor site irradiation (retained in multidisciplinary tumor board) with at least one of the following criteria :

    positive R1 margin (re-resection not proposed)

    close margin < 5 mm (re-resection not proposed)

    Margin estimated at risk, with uncertain pathological margin (re-resection not proposed)

  4. N0 after surgical management of the neck (neck dissection or sentinel lymph node biopsy) or pN1 without extracapsular extension (carcinological neck dissection)

  5. Age ≥ 18 years

  6. ECOG status ≤ 2

  7. Written signed informed consent before any specific procedure of the protocol

  8. Affiliation to a social security scheme or beneficiary of such a scheme

Critères de non-inclusion :
  1. Other histology than squamous cell carcinoma

  2. pT3 or pT4

  3. pT2>3cm and R1 with concurrent chemoradiotherapy decided in multidisciplinary tumor board

  4. Lymphovascular invasion justifying neck irradiation

  5. Neck irradiation decided in multidisciplinary tumor board

  6. Lack of at least one of the following elements :

    pre-operative medical imaging (CT scan or MRI)

    endoscopy report

    surgery report

    pathological report

  7. Prior radiotherapy to the head and neck area

  8. Distant metastasis

  9. Pregnant or nursing (lactating) woman

  10. women or men of childbearing age not taking adequate contraceptive measure

  11. participation in another investigational study within 4 weeks prior to inclusion

  12. History of other malignancy within 5 years prior enrollment except for basal cell carcinoma of the skin or carcinoma in situ of the cervix

  13. Persons deprived of their liberty, under guardianship or curatorship, or unable to follow the trial for geographical, social or psychological reasons

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Saint-Grégoire - Centre Hospitalier Privé St Gregoire Dr Chamois - Stéphanie DUREL-PINSON - sdurelpinson@vivalto-sante.com NC / NC Oui 21/02/2019
Afficher les détails
Acronyme : "205801 GSK205801 Ombrelle"
Spécialité : Pneumologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: Subjects receiving GSK3359609 (ICOS Agonist) + Docetaxel
Subjects will receive the combination once every 3 weeks as an IV infusion. Subjects receiving docetaxel will be premedicated according to approved product label or standard practice.

Drug: Docetaxel
Drug: GSK3359609 (ICOS Agonist)
Active Comparator: Subjects receiving Docetaxel
Subjects will receive docetaxel once in every 3 weeks as an intravenous infusion.

Informations

Cancer du poumon non à petites cellules (CPNPC), avancé ayant progressé à un précédent traitement anti-PD(1) et aux chimiothérapies à base de sel de platine

2ème ligne et +

Phase: 2

Promoteur: GSK
Autre(s) acronyme(s): Ombrelle
Contact promoteur: US GSK Clinical Trials Call Center

Mail promoteur: GSKClinicalSupportHD@gsk.com
Tel promoteur: 877-379-3718



Cet essai dans d'autres annuaires :

Titre :

A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

Critères d'inclusion :
  1. Subjects capable of giving signed informed consent/assent.

  2. Male or female, aged 18 years or older at the time consent is obtained.

  3. Subjects with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and: a. Documented disease progression (for example, based on radiographic imaging) during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IV or metastatic disease: i. A maximum of 1 line of platinum-containing chemotherapy regimen in the metastatic setting, and ii. A maximum of 1 line of PD(L)1 monoclonal antibody (mAb) containing regimen. b. Participants with known BRAF molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration. Participants with this alteration could have received up to 3 lines of systemic anticancer therapy.

  4. Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.

  5. ECOG PS score of 0 or 1.

  6. A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable.

  7. Adequate organ function.

  8. A male subject must agree to use a highly effective 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.

  9. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply: a) Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.

Critères de non-inclusion :
  1. Subjects who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment): a. Docetaxel at any time. b. Any of the investigational agents being tested in the current study, including experimental ICOS agonist. c. Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered. d. Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required.

  2. Received >=3 prior lines of therapy for NSCLC, including subjects with BRAF molecular alternations.

  3. Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years.

  4. Central nervous system (CNS) metastases, with the following exception: Subjects with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to first dose of study treatment.

  5. Major surgery <= 28 days of first dose of study treatment.

  6. Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments.

  7. Receiving systemic steroids (>=10 milligram [mg] oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment.

  8. Prior allogeneic/autologous bone marrow or solid organ transplantation.

  9. Receipt of any live vaccine within 30 days prior to first dose of study treatment.

  10. Toxicity from previous anticancer treatment that includes: a. >= Grade 3 toxicity considered related to prior immunotherapy and that led to treatment discontinuation. b. Toxicity related to prior treatment that has not resolved to <= Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be <= Grade 2).

  11. History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for past-pneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia.

  12. Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions.

  13. Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.

  14. History or evidence of cardiac abnormalities within the 6 months prior to enrollment.

  15. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.

  16. Active infection requiring systemic therapy.

  17. Subjects with known human immunodeficiency virus infection, or positive test for hepatitis B active infection (presence of hepatitis B surface antigen), or hepatitis C active infection.

  18. Subjects with history of severe hypersensitivity to monoclonal antibodies or hypersensitivity to ingredients used in the formulation of docetaxel.

  19. Subjects requiring ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome 3A4 (CYP3A4) enzymes.

  20. Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.

  21. Pregnant or lactating female subjects.

  22. Subject 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

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES CHU Pneumologie Dr BENNOUNA - CORVAISIER Murielle - NC / NC Oui 23/05/2019
Afficher les détails
Acronyme : "2102-HEM-101 FT-2102 Forma FT-2102-HEM-101"
Spécialité : Hématologie
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase II
Descriptif

Experimental: PH1 Dose Escalation & Expansion FT-2102
Intervention: Drug: FT-2102


Experimental: PH1 Esc. and Exp. FT-2102+Azacitidine
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH1 Esc. and Exp. FT-2102+Cytarabine
Interventions:
Drug: FT-2102
Drug: Cytarabine


Experimental: PH2 Cohort 1 FT-2102 Single Agent
At the completion of Phase 1, Phase 2 Cohort 1 will commence enrollment wherein patients with relapsed or refractory (R/R) AML will be treated with the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 2 FT-2102 Single Agent
In Phase 2 Cohort 2, patients with AML/ MDS in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after cytotoxic-containing induction therapy with residual IDH-R132 mutation will be treated at the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 3 FT-2102 Single Agent
In Phase 2 Cohort 3, patients with R/R AML/MDS, previously treated with an IDH1 inhibitor will be treated at the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 4 FT-2102+Azacitidine
In Phase 2 Cohort 4, patients with R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH2 Cohort 5 FT-2102+Azacitidine
In Phase 2 Cohort 5, patients with R/R AML/MDS that have inadequately responded or have progressed immediately proceeding hypomethylating therapy will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH2 Cohort 6 FT-2102+Azacitidine
In Phase 2 Cohort 6, patients with R/R AML/MDS that have been previously treated with single-agent IDH1 inhibitor therapy as their last therapy prior to study enrollment will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine

Informations

Leucémie myéloïde aiguë ou de syndrome myélodysplasique

mutation IDH1

récidivant ou réfractaire

2ème ligne ou +

Phase: 1,2

Promoteur: NR
Acronymes: 2102-HEM-101 FT-2102
Promoteur : Forma FT-2102-HEM-101

Source: Clinical trial.gov 2018

Cet essai dans d'autres annuaires :

Titre :

A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation

Critères d'inclusion :
  1. Pathologically proven acute myeloid leukemia (AML) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy.

  2. Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site

  3. Good performance status

  4. Good kidney and liver function

Critères de non-inclusion :
  1. Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy

  2. Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias

  3. Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication

  4. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therap

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 Dr Nimubona - - 0 / 0 Oui 29/11/2018
Afficher les détails
Acronyme : "29BRC18-0005 VinMetAtezo NCT03801304"
Spécialité : Pneumologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: Atezolizumab associated with vinorelbine

Atezolizumab will be administered with IV infusions. The first one will be a 60-min IV infusion; the subsequent infusions will last 30 minutes when well-tolerated at the dose of 1200 mg on day 1 of each 21-day cycle.
Vinorelbine capsules are taken orally on days 1, 3 and 5 of each week of the 21-day cycle. Vinorelbine will be administered at the dose of 40 mg per day on days 1, 3 and 5 of each week of the 21-day cycle. In case of toxicity, the dose will be decreased to 30 mg.

Informations

Cancer des bronches non à petites cellules (CBNPC)

2ème ligne, récurrent, localement avancé ou métastatique

Phase: 2

Promoteur: University Hospital, Brest
Autre(s) acronyme(s): VinMetAtezo
Contact promoteur: Alain VERGNENEGRE, PUPH
Contact: Sophie LECANUET

Mail promoteur: alain.vergnenegre@unilim.fr
sophie.lecanuet.pro@gmail.com
Tel promoteur: 555056629 ext +33
617987516 ext +33

-
Source: Clinical Trials 2019

Cet essai dans d'autres annuaires :

Titre :

Open Label Phase II Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung Cancer

Critères d'inclusion :
  1. Histologically confirmed NSCLC;

  2. Locally advanced and/or metastatic stage IV NSCLC (according to American Joint Committee on Cancers) or recurrent NSCLC);

  3. Patients without activating EGFR mutation or ALK rearrangement and ROS1 fusions.

  4. Subject has provided a formalin-fixed tumor-tissue sample of a tumor-lesion biopsy, either at the time of or after metastatic disease was diagnosed AND from a site not previously irradiated to assess for PDL1 status. Archived tissue may be acceptable;

  5. Patients must have a measurable lesion (RECIST V1.1);

  6. Progressive disease after first-line platinum-doublet-based chemotherapy according to RECIST V.1.1;

  7. Age ≥18 years, either sex;

  8. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;

  9. Life expectancy exceeds 12 weeks;

  10. No history of other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell or spinocellular carcinoma of the skin;

  11. Adequate organ function, demonstrated by the following laboratory results within 3 weeks prior to randomization: Normal hepatic function: bilirubin <1.5 × normal (N), Alanine aminotransferase and Aspartate aminotransferase <2.5 × N or <5 × N if liver metastasis is present;

  12. Normal renal function (calculated creatinine clearance ≥45 mL/min);

  13. Normal calcemia;

  14. Normal hematological function (polynuclear neutrophils >1.5 G/L, platelets >100 G/L);

  15. Women of child-bearing potential must use effective contraception;

  16. Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment;

  17. Written informed consent to participate in the study

  18. Patient with social insurance

Critères de non-inclusion :
  1. ECOG PS >2;

  2. Known hypersensitivity to immunotherapy;

  3. Small-cell lung cancer, bronchioloalveolar cancer, neuroendocrine cancer;

  4. Tumor harbors EGFR-sensitizing (activating) mutations or ALK translocations or ROS1 fusions and that justify treatment with targeted therapy ;

  5. Chemotherapy, hormonotherapy, immunotherapy or tyrosine-kinase inhibitors within the past 4 weeks prior to treatment with the trial drug;

  6. Radiotherapy (except bone or brain) within the past 3 months prior to baseline imaging;

  7. Medical contraindication to oral vinorelbine;

  8. Persistence of clinical adverse events related to prior treatment;

  9. Active brain metastases (e.g. stable for <4 weeks, no adequate previous radiotherapy, symptomatic, requiring anticonvulsants; dexamethasone will be allowed if administered at a stable dose <10 mg/day for at least 1 month before randomization);

  10. Concurrent radiotherapy, except for palliative bone irradiation.

  11. Other concurrent severe illnesses (congestive heart failure, unstable angina, significant arrhythmia or myocardial infarction <12 months before study entry);

  12. Active or prior documented autoimmune or inflammatory disorders;

  13. Active B hepatitis, HIV infection …;

  14. Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial;

  15. Grade-3 peripheral neuropathy;

  16. Uncontrolled infection;

  17. Interstitial lung disease or pneumonitis requiring steroid management;

  18. Corticosteroid therapy exceeding 10 mg/day;

  19. Other severe organic disorders not allowing inclusion in the trial;

  20. Malabsorption syndrome;

  21. Pregnancy or breast-feeding;

  22. Follow-up not possible; and incarcerated or institutionalized patients.

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 Dr Hervé Lena - herve.lena@chu-rennes.fr ARCs/IRCs Pneumologie - ide-pneumo-arc@chu-rennes.fr NC / 3 Oui 29/03/2019
Afficher les détails
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

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 26/04/2019
Afficher les détails
Acronyme : "BGB-290-303 2017-003493-13"
Spécialité : Digestif
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

"Experimental: Arm A
Approximately 270 subjects to receive BGB-290 orally.
Intervention: Drug: BGB-290

Placebo Comparator: Arm B
Approximately 270 subjects to receive placebo orally.
Intervention: Drug: Placebo"

Informations

Cancer de l'estomac locallement avancé inopérable ou métastatique

Ayant répondu à une première ligne de platine

maintenance

Phase: 3

Promoteur: BeiGene
Acronymes: BGB-290-303
2017-003493-13
Contact promoteur: Heinrich Farin, MD

Mail promoteur: Clinicaltrials@beigene.com
Tel promoteur: 781-801-1800
Coordonnateur: NR
-
Source: Clinicaltrials.gov du 02/05/2018"

Cet essai dans d'autres annuaires :

Titre :

A Phase 3, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy

Critères d'inclusion :
  1. "Age ≥ 18 years.

  2. Signed informed consent.

  3. Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.

  4. Received platinum based first line chemotherapy for ≤ 28 weeks.

  5. Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).

  6. Able to be randomized to study ≤ 8 weeks after last platinum dose.

  7. ECOG performance status ≤ 1.

  8. Adequate hematologic, renal and hepatic function.

  9. Must be able to provide archival tumor tissue for central biomarker assessment.

  10. Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study and at least up to 6 months after last "

Critères de non-inclusion :
  1. "Unresolved acute effects of prior therapy ≥ Grade 2.

  2. Prior treatment with PARP inhibitor.

  3. Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days prior to randomization.

  4. Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.

  5. Diagnosis of myelodysplastic syndrome (MDS) or active bleeding disorder.

  6. Other diagnoses of significant malignancy

  7. Leptomeningeal disease or brain metastasis

  8. Inability to swallow capsules or disease affecting gastrointestinal function.

  9. Active infections requiring systemic treatment.

  10. Clinically significant cardiovascular disease

  11. Pregnant or nursing females."

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 Dr J. P. Metges - RASSOUL HAYAT AGATHE - hayat.guezi@chu-brest.fr / Oui 02/05/2018
Rennes - Centre Eugène Marquis Dr Le Sourd Samuel - Enora Lejeune - nc / nc Oui 17/09/2018
Afficher les détails
Acronyme : "Bladder-ART GETUG-AFU 30 UC-01610/1617"
Spécialité : Urologie
Traitement : Traitement adjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Sans phase
Descriptif

Experimental: Experimental Arm
adjuvant pelvic radiotherapy consisting of 28 x 1.8 Gy fractions (total dose of 50.4 Gy), 5 days per week, 1 fraction /day (duration of RT is 38 days).
Intervention: Radiation: pelvic radiotherapy


No Intervention: Standard Arm
Surveillance

Informations

Carcinome urothélial pur ou dominant supérieur ou égale à 50 % associé à des variants histologiques micropapillaire, épidermoïde ou adénocarcinome

Vessie

 

Radiothérapie adjuvante

Sans Phase

Promoteur: UNICANCER
Acronymes: Bladder-ART GETUG-AFU 30
UC-01610/1617
Contact promoteur: Sandra PELISSIER

Mail promoteur: s-pelissier@unicancer.fr
Tel promoteur: 33 1 44 23 55 68
Coordonnateur:
Paul SARGOS,
Stéphane LARRE, Prof
Mail coordonnateur: MD Institut Bergonié
CHU Robert Debré
-
Source: Clinical trial octobre 2018"

Cet essai dans d'autres annuaires :

Titre :

Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer: A Randomized Multicentre Phase II Study

Critères d'inclusion :

To be eligible, the patients must fulfil all of the following inclusion criteria:

  1. Patients with histologically-confirmed muscle-invasive bladder cancer, either with pure urothelial carcinomas, or dominant urothelial carcinomas (>50%) combined with other histological variants including: micropapillary, epidermoid, or adenocarcinomas, are eligible. Patients with small cell variants, pure adenocarcinomas, or pure epidermoid carcinomas are not eligible.

  2. Patients with radical cystectomy and pelvic lymph nodes dissection with no macroscopic residual disease (R0 and R1).

    Note that only R1 patients without urinary diversion as orthotropic neo-bladder replacement are eligible for the study, to limit cystectomy bed radiation induced toxicities

  3. Patients with tumours of TNM staging: pN0-2, M0 by imagery, and pT3a, pT3b, pT4a, and pT4b, as well as, pTX-pN1-2 are eligible.

  4. Patients having received neo-adjuvant or adjuvant chemotherapy treatment are eligible. Randomisation is allowed only if AE due to chemotherapy are ≤grade 2

  5. Patients ≥18 years old.

  6. ECOG performance status ≤2.

  7. Absolute neutrophil count (ANC) ≥1500 cells/mm3

  8. Platelets ≥100000 cells/mm3

  9. Haemoglobin ≥8 g/dL (Note: following a blood transfusion or another intervention if required).

  10. Adequate hepatic function: AST (SGOT) and ALT (SGPT) ≤2.5 x ULN; or ≤3.5 x ULN in the case of concurrent disease with known etiology and for which a corrective treatment is possible.

  11. Adequate renal function: clearance >30 mL/min (MDRD).

  12. Patients of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 6 months after the adjuvant radiotherapy. Acceptable method of contraception includes: hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal associated with inhibition of ovulation (oral, intravaginal, transdermal), intrauterine devices, sexual abstinence, bilateral tubal ligation, vasectomy, for female: partner who have had a vasectomy, for male: partner who is not of childbearing potential. Women must have a negative urine or serum pregnancy test within 14 days prior to randomization.

  13. Patients having provided written informed consent prior to any study-related procedures.

  14. Patients affiliated to the social security scheme.

  15. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.

Critères de non-inclusion :

Patient must not be enrolled if he/she fulfils any of the following non-inclusion criteria:

  1. Patients with R1 resection and with orthotropic neo-bladder reconstruction as urinary diversion are not eligible.

  2. Patients with clinical or radiological evidence of metastases or N3 staged bladder cancer are not eligible.

  3. Prior invasive solid tumours or haematological malignancies (except skin basal cell carcinoma, in situ epithelioma of the cervix, or prostate cancer [incidentally discovered during cystoprostatetectomy and pelvic lymph node dissection)] and with a good prognosis [T stage <pT3b and/or Gleason <8 and pN- and/or post-operative PSA <0.1 nanogramm/mL]), unless disease free for a minimum of three years prior to inclusion.

  4. Prior pelvic radiotherapy.

  5. Patients with active inflammatory bowel disease.

  6. Patients who required surgical treatment for bowel obstruction before bladder cancer diagnosis or after cystectomy.

  7. Prior chemotherapy for other malignant diseases, except for neoadjuvant pre-cystectomy chemotherapy which is permitted.

  8. Patients with the following severe acute co-morbidity are not eligible:

    Unstable angina or congestive heart failure that required hospitalization in the 6 months before randomisation.

    Transmural myocardial infarction in the 6 months prior to randomisation.

    Acute bacterial or fungal infection requiring intravenous antibiotics at randomization.

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of inclusion.

    Severe hepatic disease: Child-Pugh Class B or C hepatic disease.

    Known acquired immune deficiency syndrome (AIDS); the study treatment could impact blood count.

  9. Patients with any other disease or illness which requires hospitalization or is incompatible with the study treatment are not eligible.

  10. Patients unable to comply with study obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the study.

  11. Patients enrolled in another therapeutic study within 30 days prior of randomisation.

  12. Pregnant or breast feeding mothers.

  13. 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
Saint-Grégoire - Centre Hospitalier Privé St Gregoire Dr Artignan - Stéphanie DUREL-PINSON - sdurelpinson@vivalto-sante.com / Oui 26/11/2018
Afficher les détails
Acronyme : "CHEMOIMMUNE ET16-073 2016-002736-33 "
Spécialité : Sénologie
Traitement : Thérapie ciblée néoadjuvante (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

"Cyclophosphamide et pembrolizumab
The treatments received are:

  • cyclophosphamide (50 mg/day, daily, per os)
  • pembrolizumab (200 mg every 3 weeks, intravenously [IV]). On days 1, cyclophosphamide should be taken first and pembrolizumab infusion initiated within 1 hour after cyclophosphamide intake.

Interventions:
Drug: Cyclophosphamide 50mg
Drug: Pembrolizumab 100 MG in 4 ML Injection"

Informations

Cancer du sein métastatique - HER2- 

> ou = 2ieme ligne de traitement 

1iere ligne si prétraitée en néoadjuvant ou adjuvant par une thérapie à base de taxane ou anthracycline

Phase: 2

Promoteur: Centre Léon Berard
Autre(s) acronyme(s): ET16-073
2016-002736-33
Contact promoteur:
Contact: Olivier TREDAN, MD

Mail promoteur: olivier.tredan@lyon.unicancer.fr
Tel promoteur: 33478782828
-
Source: clinicaltrials.gov 18/06/2018"

Cet essai dans d'autres annuaires :

Titre :

CHEMOIMMUNE - A Phase II Study Evaluating an Anti-PD1 Monoclonal Antibody (Pembrolizumab) in Lymphopenic Metastatic Breast Cancer Patients Treated With Metronomic Cyclophosphamide

Critères d'inclusion :
  • Female patient>=18 years of age on day of signing informed consent.

  • Histologically proven HER2-negative metastatic breast cancer. HER2-negativity is defined as immunohistochemistry (IHC) score 0, 1+ or 2+ and fluorescent in situ hybridization (FISH) negative or just FISH negative, whichever was performed.

  • Patient previously treated with at least one prior line of standard chemotherapy either in the adjuvant setting or in the metastatic setting. Patients may be included in the first line metastatic setting if they have received anthracycline and/or taxane-based therapy in the neoadjuvant/adjuvant setting.

Note: Patients with ER-positive tumors must have received at least one prior endocrine therapy, either in the adjuvant setting or in the metastatic setting.
Documented lymphopenia defined by at least one value of lymphocyte count < 1.5 G/L within 15 days before treatment start (C1D1) and following at least 15 days since the last administration of chemotherapy.
Biopsiable disease i.e. at least one lesion with a diameter ≥ 10 mm, visible by medical imaging and accessible to percutaneous sampling.
Patient willing to undergo 2 tumor biopsies (at inclusion and at C3D1).
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2 and minimum life expectancy of 24 weeks.

  • Documented radiological disease progression at time of study entry.

  • At least one measurable lesion according to RECIST 1.1.

  • Adequate end organ and marrow function as defined below: all screening labs should be performed within 3 days before treatment start (C1D1).

Hematological Laboratory Values Absolute neutrophil count (ANC) ≥ 1.5G/L Platelets ≥ 100G/L Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (without transfusion within 7 days of assessment) Renal Laboratory Values Serum creatinine ≤ 1.5 X upper limit of normal (ULN) or Calculated creatinine clearance as per MDRD or CKD-EPI formula ≥ 60 mL/min /1.73m2 Hepatic Laboratory Values Serum total bilirubin ≤ 1.5 X ULN or Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN LDH ≤ 1.5 ULN Albumin ≥ 25 g/L Coagulation Laboratory Values International Normalized Ratio (INR) ≤ 1.5 ULN Ratio of activated Partial Thromboplastin Time (aPTT) ≤ 1.5 ULN

  • Absence of prior significant treatment-related toxicity i.e. treatment-related toxicity > Grade 1 as per CTCAE v4.03 (Appendix 2), except grade 2 alopecia, grade 2 neuropathy and biological values as described in I10.

  • Women of child-bearing potential must have a negative serum pregnancy test within 3 days before C1D1.

  • Women of child-bearing potential must agree to use 2 effective forms of contraception from the time of the negative pregnancy test up to 120 days after the last dose of study drugs. Effective forms are detailed in Appendix 5.

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

  • Patients must be covered by a medical insurance.

Critères de non-inclusion :
  • Previously treated with more than 3 prior lines of chemotherapy in the metastatic setting

  • Has previously received therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death 1 ligand 1(PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.

  • Presenting any contraindication to cyclophosphamide treatment including known hypersensitivity to cyclophosphamide, inflammation of the bladder (cystitis), urinary outflow obstruction or active infection.

  • Requiring the use of concomitant medications defined as forbidden in the SPC of cyclophosphamide.

  • Hypersensitivity to pembrolizumab or any of its excipients.

  • Has a known history of active Bacillus Tuberculosis.

Prior treatment with:

  1. any investigational agent within 4 weeks before C1D1 (or 5 half-lives whichever is shorter with a minimum of 2 weeks);
  2. any systemic corticosteroids at doses higher than 10 mg/d of prednisolone or equivalent or immunosuppressive agent within 4 weeks before C1D1;
  3. any monoclonal antibody within 4 weeks before C1D1;
  4. any chemotherapy, targeted small molecule therapy, radiation therapy, or surgery within 2 weeks prior to C1D1.

Note: If a patient underwent a major surgical procedure, they must have adequately recovered from the toxicity (i.e. wound healing) and/or complications from the intervention prior to starting therapy.
* any live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.

  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to C1D1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 28 days prior to C1D1. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.

  • Has active autoimmune disease that has required systemic treatment in the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids at doses higher than 10 mg/d of methylprednisolone or equivalent or immunosuppressive agents.

Note: Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Patients with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.

  • Has an history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active non-infectious pneumonitis.

  • Has an active infection requiring systemic therapy.

  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

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

  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) or active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).

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 FRENEL Jean Sébastien - - / Oui 28/01/2019
ANGERS - Institut de Cancérologie de l'Ouest Dr FRENEL Jean Sebastien - - / Oui 19/06/2018
Afficher les détails
Acronyme : "COMBIAPLUS-mélanome COMBI-Aplus CDRB436F2410"
Spécialité : Dermatologie
Traitement : Chimiothérapie adjuvante
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Dabrafenib and trametinib combination therapy
Subjects will receive dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.

Informations

Mélanome de stade III - Mutation BRAFV600- Adjuvant

Soins de support

05/03/2019 : nouveau critère d'exclusion : exclure les patients ayant déjà eu un mélanome de stade III

Phase: 3 b

Promoteur: Novartis
Autre(s) acronyme(s): COMBIAPLUS-mélanome COMBI-Aplus
Contact promoteur: Novartis Pharmaceuticals
Mail promoteur: novartis.email@novartis.com


Tel promoteur: 41613241111
81337978748
Coordonnateur: NR
-
Source: Clinical trials 2018

Cet essai dans d'autres annuaires :

Titre :

Open label, phase IIIB study of Dabrafenib in combination with trametinib in the adjuvant treatment of stage III V600 mutation-positive melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adaptated pyrexia AE-management algorythm.

Critères d'inclusion :
  1. Completely resected (R0) histologically confirmed cutaneous melanoma stage IIIA (LN metastasis >1 mm), IIIB, IIIC, IIID [AJCC (ed 8)]

  2. V600E/K mutation positive using a validated local test

  3. Subjects presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible.

  4. Subjects with an unknown primary melanoma are not eligible.

  5. Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).

  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

Critères de non-inclusion :
  1. Uveal or mucosal melanoma

  2. Evidence of metastatic disease including unresectable in-transit metastasis

  3. Received any prior adjuvant treatment, including but not limited to chemotherapy, checkpoint inhibitors, targeted therapy [e.g., BRAF and/or MEK inhibitors], biologic therapy, vaccine therapy, investigational treatment, or radiotherapy for melanoma

  4. Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ

  5. History or current evidence of cardiovascular risk

  6. A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Lorient - Centre Hospitalier Bretagne Sud Dr Jacobzone - Nolwen Leissen - n.leissen@ch-bretagne-sud.fr

Tel: 02.97.06.74.61

NC / NC Oui 21/05/2019
Rennes - Centre Eugène Marquis Dr Thierry Lesimple - Sophie Gimenez - s.gimenez@rennes.unicancer.fr nc / nc Oui 21/05/2019
Afficher les détails

Fiche détaillée de l'essai