Sélectionnez un ou plusieurs critères :
Ou bien effectuez une recherche par mots-clés :
Recherche avancée
Signaler une étude manquante, non à jour ou une erreur
Avertissement : Ces informations sont données à titre indicatif. Veuillez vous reporter aux documents en vigueur fournis par le Promoteur. Toute utilisation d'un schéma thérapeutique non validé est sous la responsabilité du prescripteur.
348 essais correspondent à votre recherche

Fiche détaillée de l'essai

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 : "CA209-"CA209-8KX CA209 KX 2018-001585-42 EudraCT Numbe NCT03656718" CA209 KX 2018-001585-42 EudraCT Numbe NCT03656718"
Spécialité : Dermatologie
Traitement : Thérapie ciblée adjuvante (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase II
Descriptif

"
Experimental: SC nivolumab

Biological: Nivolumab
Drug: rHuPH20
Experimental: SC nivolumab with rHuPH20

Biological: Nivolumab
Drug: rHuPH20"

Informations

CBNC, Carcinome à cellules rénales, Carcinome hépato-cellulaire, Mélanome métastatique ou non résécable, Cancer Colo-rectal,

2ème ligne et +

Inclusion suspendues16/07/2019

Phase: 1-2

Promoteur: Bristol-Myers Squibb
Autre(s) acronyme(s):
CA209 KX
2018-001585-42 EudraCT Numbe
NCT03656718
Contact promoteur: Bristol-Myers Squibb

Source: Clinical Trial 2019

Cet essai dans d'autres annuaires :

Titre :

Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy

Critères d'inclusion :

Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types:

  1. Metastatic squamous or non-squamous NSCLC

  2. RCC, advanced or metastatic

  3. Melanoma

  4. HCC

  5. CRC, metastatic (MSI-H or dMMR)

  6. Measurable disease as per RECIST version 1.1 criteria

  7. ECOG performance status of 0 or 1

Critères de non-inclusion :
  1. Active brain metastases or leptomeningeal metastases

  2. Ocular melanoma

  3. Active, known, or suspected autoimmune disease

  4. Other protocol defined inclusion/exclusion criteria could apply

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 RAIMBOURG Judith - PARERE Adèle - NC / NC Oui 31/05/2019
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 : "CHIPOR FEDEGYN 02 0410-CHIPOR 2010-023035-42 ( EudraCT Number ) NCT01376752"
Spécialité : Gynécologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif


Arm Intervention/treatment
Active Comparator: maximal cytoreductive surgery without HIPEC
The participant will have a regular cytoreductive surgery without the adjunction of HIPEC.
Procedure: Maximal cytoreductive surgery
Maximal cytoreductive surgery

Experimental: maximal cytoreductive surgery with HIPEC
The participant will have a regular cytoreductive surgery, then the adjunction of HIPEC: hyperthermic cisplatin will be used at 75mg/m²
Procedure: Maximal cytoreductive surgery
Maximal cytoreductive surgery

Drug: HIPEC
HIPEC: Hyperthermic Intra-PEritoneal Chemotherapy. Administration of cisplatin at 75mg/m²

Informations

Cancer de l'ovaire en rechute, opérable

3ème ligne et +

Phase: 3

Promoteur: UNICANCER
Autre(s) acronyme(s): FEDEGYN 02
0410-CHIPOR
2010-023035-42 ( EudraCT Number )
Contact promoteur: Nicolas LACHAUX

Mail promoteur: n-lachaux@unicancer.fr
Tel promoteur: 33 1 71 93 61 60

-
Source: Clinical Trial 2019"

Cet essai dans d'autres annuaires :

Titre :

A Phase III Randomized Study Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer

Critères d'inclusion :
  1. Patient age ≥ 18 years

  2. Performance Status WHO < 2

  3. Initially treated for Epithelial Ovarian Carcinoma

  4. Patient with only peritoneal relapse occurred at least 6 month from the initial treatment, resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable lymph-nodes in the groin or retro peritoneal)

  5. Platinum based second-line chemotherapy before surgery with either carboplatine-paclitaxel, or carboplatine-caelyx

  6. Complete cytoreductive surgery

  7. The surgery has to be planned 5 to 8 weeks from the last 2nd of chemotherapy

  8. No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit

  9. No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine clearance > 80 mL/min). calculated with MDRD method

  10. Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L

  11. No contraindication to general anaesthesia for heavy surgery

  12. Patients having read, signed and dated Informed consent before any study procedure

  13. Childbearing patients have to take appropriate contraceptive methods during the treatment and until 6 months after the treatment

Critères de non-inclusion :
  1. Patient age <18 years

  2. Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma)

  3. Hypersensitivity to Platinum compound

  4. Distant metastasis

  5. Use of anti-angiogenic treatment

  6. Patient with other concurrent severe life threatening disease

  7. The need to perform more than two segmental digestive resections during the CRS +/- HIPEC surgery

  8. Any progressive disease during the IV systemic second-line chemotherapy (platine-based)

  9. Incomplete cytoreductive surgery with macroscopical residual disease (Sugarbaker > CC1)

  10. Early relapse: less than 6 mois after the end of the first treatment

  11. Ovarian tumor other than Epithelioma Ovarian Cancer

  12. Uncontrolled infection

  13. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

  14. Clinically significant cardiovascular disease contraindicating the hyper hydratation, which is necessary for HIPEC

  15. Patient already treated with HIPEC for the ovarian cancer

  16. Individual 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
Brest - Clinique Pasteur Lanroze Dr Lucas - - NC / NC Oui 04/06/2019
Afficher les détails
Acronyme : "COSMIC-021 XL184-021 NCT03170960"
Spécialité : Pneumologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

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

Drug: cabozantinib

Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
Cabometyx
XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Name: Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
Cabometyx
XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
Cabometyx
XL184

Informations

Cancer du rein, prostate, vessie, uretère, urètre, CNBPC

Localement avancé ou métastatique

Phase: 1b

Promoteur: EXELIXIS
Autre(s) acronyme(s): NCT03170960
Contact promoteur: Exelixis Clinical Trials
Mail promoteur: 888-393-5494
Tel promoteur: druginfo@exelixis.com
Coordonnateur: NR
-
Source: Clinical Trial

Cet essai dans d'autres annuaires :

Titre :

A Phase 1b Dose- Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination with Atezolizumab to Subjects with Locally Advanced or Metastatic Solid Tumors

Critères d'inclusion :
  1. Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent:

  2. Dose-Escalation Stage:

  3. Subjects with UC (including renal pelvis, ureter, bladder, urethra) after prior platinum-based therapy, or

  4. Subjects with RCC (clear cell, non-clear cell histology) with or without prior systemic anticancer therapy

  5. Expansion Stage:

  6. Inoperable locally advanced or metastatic solid tumor (UC, RCC, CRPC, NSCLC, TNBC, OC, EC, HCC, GC/GEJC/LEC, CRC, H&N cancer, and DTC as outlined above)

  7. Measurable disease per RECIST 1.1 as determined by the investigator.

  8. Tumor tissue material available (archival or recent tumor biopsy)

  9. Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.

  10. Age eighteen years or older on the day of consent.

  11. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

  12. Adequate organ and marrow function.

  13. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception.

  14. Female subjects of childbearing potential must not be pregnant at screening.

Critères de non-inclusion :
  1. Prior treatment with cabozantinib or immune checkpoint inhibitors including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy except in Expansion Cohorts 5, 7, 9, 11, 17, 19 and 20. Other restrictions regarding prior therapy may apply.

  2. Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 4 weeks before first dose of study treatment.

  3. Concomitant anticoagulation with oral anticoagulants.

  4. Subject is receiving systemic steroid therapy (>10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment.

  5. Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.

  6. The subject has uncontrolled, significant intercurrent or recent illness, including, but not limited to, an active or history of autoimmune disease or immune deficiency; idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV), AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).

  7. Pregnant or lactating females.

  8. Previously identified allergy or hypersensitivity to components of the study treatment formulations.

  9. Diagnosis of another malignancy within 2 years before 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
Saint-Grégoire - Centre Hospitalier Privé St Gregoire Dr Artignan - Stéphanie DUREL-PINSON - sdurelpinson@vivalto-sante.com NC / NC Oui 23/07/2020
Saint-Grégoire - Centre Hospitalier Privé St Gregoire Dr Artignan - Stéphanie DUREL-PINSON - sdurelpinson@vivalto-sante.com NC / NC Oui 23/07/2020
Afficher les détails
Acronyme : "COSMIC-313 XL184-313 NCT03937219"
Spécialité : Urologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Experimental Arm
Cabozantinib + nivolumab + ipilimumab (4 doses) followed by cabozantinib + nivolumab

Active Comparator: Control Arm
Cabozantinib-matched placebo + nivolumab + ipilimumab (4 doses) followed by cabozantinib-matched placebo + nivolumab

Informations

Cancer du rein, avancé ou métastatique,

1ère ligne

Phase: 3

Promoteur: Exelixis
Autre(s) acronyme(s): XL184-313
NCT03937219
Contact promoteur: Exelixis Clinical Trials 1-888-EXELIXIS
Mail promoteur: 888-393-5494
Tel promoteur: druginfo@exelixis.com

Source: Clinical Trial"

Cet essai dans d'autres annuaires :

Titre :

A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk

Critères d'inclusion :
  1. Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component.

  2. Intermediate- or poor-risk RCC as defined by International Metastatic RCC Database Consortium (IMDC) criteria.

  3. Measurable disease per RECIST 1.1 as determined by the Investigator.

  4. Karnofsky Performance Status (KPS) ≥ 70%.

  5. Adequate organ and marrow function.

Critères de non-inclusion :
  1. Prior systemic anticancer therapy for unresectable locally advanced or metastatic RCC including investigational agents.

  2. Uncontrolled, significant intercurrent or recent illness including, but not limited to serious cardiovascular disorders (including uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment), GI disorders associated with high risk for perforation or fistula formation, tumors invading GI tract, bowel obstruction, intra-abdominal abscess, clinically significant bleeding events, cavitating pulmonary lesions, or lesions invading major pulmonary blood vessels.

  3. Other clinically significant disorders such as:

    i. Autoimmune disease that has been symptomatic or required treatment within the past two years from the date of randomization.

    ii. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. iii. Active infection requiring systemic treatment. Acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active myobacterial infection.

  4. Major surgery (eg, nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization. Minor surgeries within 10 days prior to randomization. Subjects must have complete wound healing from major or minor surgery before randomization.

  5. Any other active malignancy at time of randomization or diagnosis of another malignancy within 3 years prior to randomization that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

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 Brigitte Laguerre - Enora Michel - e.michel@rennes.unicancer.fr NC / NC Oui 05/06/2020
Afficher les détails
Acronyme : "CR107947 63935937MDS3001 2015-002874-19
Spécialité : Hématologie
Traitement : Protocole de traitement
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Titre :

A Study to Evaluate Imetelstat (JNJ-63935937) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

Critères d'inclusion : Critères de non-inclusion :
Centres investigateurs

Afficher les détails
Acronyme : "CRUCIAL EORTC-1714 2018‐000053‐53 ( EudraCT Number ) NCT03437200 "
Spécialité : Digestif
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: Arm A: Chemoradiation + Nivolumab
All patients will receive standard fractionation radiation therapy (RT) scheme: 50Gy in 25 fractions over 5 weeks (i.e. 2Gy per fraction), concurrently with 3 cycles of 2 weeks of FOLFOX followed by 3 cycles of 2 weeks of FOLFOX without RT.
Induction phase: Nivolumab IV 240 mg on days 1, 15 and 29 followed by a maintenance phase (to start on day 43) of Nivolumab IV 240 mg q2 weekly for up to 1 year.

Experimental: Arm B: Chemoradiation + Nivolumab + Ipilimumab
Same as arm A + induction phase: Ipilimumab IV 1 mg/kg on day 1 followed by a maintenance phase (to start on day 43) of Ipilimumab IV 1 mg/kg q6 weekly for up to 1 year

Informations

Cancer de l'oesophage, non opérable, avancé ou métastatique

2ème ligne et +

 

Phase: 2

Promoteur: European Organisation for Research and Treatment of Cancer - EORTC
Autre(s) acronyme(s): EORTC-1714
2018‐000053‐53 ( EudraCT Number )
NCT03437200

Contact promoteur: EORTC HQ +@gmail.com

Mail promoteur: 32 2 7744 1611
Tel promoteur: 1714@gmail.com

Coordonnateur: Eric Deutsch
-
Source: Clinical Trial 2019

Titre :

Phase II Trial in Inoperable œsophageal Cancer Evaluating the Feasibility of the Combination of Definitive Chemoradiation With the Immune Checkpoint Blockers Nivolumab +/- Ipilimumab

Critères d'inclusion :
  1. Histologically proven oesophageal squamous cell carcinoma or adenocarcinoma

  2. Both early stage and locally advanced tumor patients (according to TNM staging version 8):

  3. T1, N1-3, M0 after complete work-up

  4. T2, N0-3, M0 after complete work-up

  5. T3, N0-3, M0

  6. Patient eligible for definitive chemoradiation and not considered for primary surgery after multidisciplinary meeting decision or patient refuses to undergo surgery

  7. Subject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease

  8. At least one measurable lesion by CT scan or MRI based on RECIST version 1.1 with radiographic tumor assessment performed within 28 days prior to randomization

  9. Availability of adequate tissue in terms of quality and quantity for immunohistochemical staining for PDL-1

  10. WHO performance status 0 or 1

  11. Adequate organ function within 14 days prior to randomization

Critères de non-inclusion :
  1. Cancer of cervical oesophagus (15 to 19 cm from dental ridge)

  2. Known Her2 positive adenocarcinoma

  3. Weight loss > 15 % over the last 3 months without improvement after nutritional support

  4. Patient with cardiac dysfunction e.g. symptomatic congestive heart failure, uncontrolled hypertension

  5. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.

  6. Any prior treatment for advanced disease including treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

  7. Live vaccines within 30 days prior to the first dose of study therapy. Examples of live vaccines include, but are not limited to the following: measles, mumps, rubella, chicken pox, yellow fever, H1N1 flu, rabies, BCG, and typhoid vaccine

  8. History of hypersensitivity to study drugs or any excipient (refer to SmPCs for ipilimumab, nivolumab, 5-FU and oxaliplatin)

  9. Current participation or treatment with an investigational agent or use of an investigational agent within 4 weeks of the first dose of study treatment

  10. Serious comorbidity or life expectancy less than one year

  11. Contraindication to chemoradiation therapy

  12. Treatment history of radiotherapy

  13. Child-Pugh B/C and patients with history of acute or chronic pancreatitis

  14. Patient with Type I diabetes mellitus, or skin disorders

  15. Known severe systemic autoimmune disease affecting the lungs or the bowel

  16. Known contraindication to CT scans with IV contrast

  17. Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 15 days prior to enrollment

  18. Active autoimmune disease that has required systemic treatment in past 2 years

  19. Autoimmune paraneoplastic syndrome requiring immunosuppressive or dedicated treatment

  20. History of any other hematologic or primary solid tumor malignancy, unless in remission for at least 5 years

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 03/06/2019
Afficher les détails
Acronyme : "DAISY UC-0105/1815 NCT04132960 "
Spécialité : Gynécologie - Sénologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Drug: DS-8201a
Anti-HER2-antibody drug conjugate (ADC)

Informations

Cancer du sein métastatique

2ème ligne et +

Experimental: HER2 status
Cohort 1: HER2 over-expressing (HER2 IHC3+ or HER2 IHC2+/ISH+) suspendue
Cohort 2: HER2 low-expressing (IHC1+ or IHC2+/ISH-) ré-ouverte le 14/05/2020
Cohort 3: HER2 non-expressing (IHC0+) suspendue

Phase: 2
Promoteur: UNICANCER
Autre(s) acronyme(s): UC-0105/1815
NCT04132960

Contact promoteur: Céline MAHIER AIT OUKHATAR
Marta JIMENEZ
Mail promoteur: c-mahier@unicancer.fr
m-jimenez@unicancer.fr

Tel promoteur: 01 44 23 55 84
01 44 23 55 58
Coordonnateur: Dr V. DIERAS CEM
Mail coordonnateur: NR
Tel Coordonnateur: NR
-
Source: Clinical Trial"

Cet essai dans d'autres annuaires :

Titre :

Phase II, Open Label Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC) for Advanced Breast Cancer Patients, With Biomarkers Analysis to Characterize Response/Resistance to Therapy

Critères d'inclusion :
  1. Patient must have signed a written informed consent form prior to any study specific procedures. When the patient is physically unable to give his/her written consent, a trusted person of his/her choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.

  2. Female or male subjects aged ≥18 years.

  3. Patient with histologically-confirmed diagnosis of invasive breast cancer. Tumors can be either HER2 immunohistochemistry (IHC)3+/in situ hybridization (ISH) positive or IHC2+/ISH positive or IHC2+/ISH negative or IHC1+ or IHC0+, of most recent tumor tissue sample available.

  4. Patient with a documented radiologic metastatic progression.

  5. Patient considered by the investigator as not amenable to any other validated therapeutic option, after at least 1 line of chemotherapy in metastatic setting. Patient must have been previously treated with anthracyclines and taxanes (in (neo-)adjuvant and/or metastatic setting). Additionally:

    Patient with HER2 over-expressing (IHC3+ and IHC2+/ISH+) tumor must have been treated and have progressed on trastuzumab and on TDM-1. Prior treatment with pertuzumab is not required.

    Patient with HER2 negative (IHC0, 1+, and 2+/ISH-) and hormone receptor positive (estrogene receptor (ER)+ and/or progesterone receptor (PR)+) tumor must be resistant to endocrine therapy and CDK4/6 inhibitors, and must have been treated with capecitabine.

  6. Non-bone metastatic site easily accessible to biopsy.

  7. Presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

  8. Patient with world health organization (WHO) performance status ≤1.

  9. Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, and hemoglobin ≥9 g/dL (transfusion is not allowed within 1 week prior to baseline assessment).

  10. Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range if no liver metastases or <3 x ULN in the presence of documented Gilbert's Syndrome or liver metastases. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤3 × ULN (AST and ALT≤ 5 ULN when documented liver metastasis).

  11. Adequate blood clotting function: International Normalized Ratio (INR)/Prothrombin Time (PT) and activated Partial Thromboplastin Time (aPTT) ≤1.5 x ULN.

  12. Adequate renal function: estimated creatinine clearance ≥30 mL/min according to the Cockcroft-Gault formula or serum creatinine ≤1.5 x ULN.

  13. Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before inclusion.

  14. Male and female subjects of reproductive/childbearing potential must agree to use of a highly effective contraception for subjects throughout the study and for at least 4.5 months after last study treatment administration if the risk of conception exists.

  15. Women of childbearing potential must have a negative serum pregnancy test within 14 days of enrolment or urine pregnancy test 72 hours prior to enrolment.

  16. Patient is willing to comply with 2 sequential tumor biopsies (baseline and at first progression), and with a series of blood samples throughout the study.

  17. Patients must be affiliated to a Social Security System

Critères de non-inclusion :
  1. Patient with a breast cancer amenable for resection or radiation therapy with curative intent.

  2. Patient has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy.

  3. Patient with bone metastatic disease only.

  4. Patient with multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.

  5. Persistent unresolved toxicities with grade ≥2 (except alopecia and renal function). Subject with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator after consultation with the Sponsor (eg, Grade 2 chemotherapy-induced neuropathy).

  6. Patient receiving treatments such as chemotherapy (including antibody drug therapy, retinoid therapy, hormonal therapy) within 3 weeks before inclusion (within 2 weeks or 5 half-lives, whichever is longer, for small-molecule targeted agents, within 6 weeks for nitrosureas or mitomycin C), immunotherapy within 4 weeks before inclusion, radiotherapy within 4 weeks (if palliative stereotactic radiotherapy: within 2 weeks) or major surgery within 4 weeks. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation.

  7. Patient using drugs that could have pharmacokinetics interaction with investigational drugs. Concomitant use of strong CYP3A4 inhibitors or OATP 1B inhibitors should be avoided. If concomitant use of strong CYP3A4 or OATP 1B inhibitors is unavoidable, consider delaying DS-8201a treatment until the inhibitors have cleared from the circulation (approximately 3 elimination half-lives of the inhibitors) when possible. If a strong CYP3A4 inhibitor or an OATP 1B inhibitor is co-administered and DS-8201a treatment cannot be delayed, patients should be closely monitored for adverse reactions.

  8. Patients with a concomitant use of chronic systemic (intravenous or oral) corticosteroids or other immunosuppressive medications except for managing adverse events (inhaled steroids or intra articular steroid injections are permitted in this study.) Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study.

  9. Patient with history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.

  10. Patient with clinically significant corneal disease in the opinion of the Investigator.

  11. Known prior severe hypersensitivity to investigational product or any component in its formulation, including known severe hypersensitivity reactions to study drug (National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 Grade ≥3).

  12. Patient has a history of severe hypersensitivity reactions to other monoclonal antibodies.

  13. Patients previously treated with topoisomerase 1 inhibitor.

  14. Patient has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the Investigator.

  15. Known history of testing positive for HIV or known acquired immunodeficiency syndrome.

  16. Known active hepatitis B virus or hepatitis C virus infection at screening.

  17. Active infection requiring systemic therapy (as intravenous antibiotics, antivirals, antifungals,…).

  18. Other severe acute or chronic medical conditions or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

  19. Patient with a history of symptomatic congestive heart failure (New York Heart Association Class II to IV), serious cardiac arrhythmia requiring treatment, history of myocardial infarction or troponin levels consistent with myocardial infarction 28 days prior to inclusion, or unstable angina within 6 months prior to inclusion, or current dyspnea at rest due to advanced malignancy.

  20. Patient with a corrected QT interval (QTc) prolongation to >470 ms (females) or >450 ms (males) based on average of the screening triplicate12-lead electrocardiogram (ECG).

  21. Pregnant women, women who are likely to become pregnant or are breastfeeding or women who want donate, or retrieve for their own use, ova from the time of screening and throughout the study and for at least 4.5 months after last study treatment administration.

  22. Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

  23. Patient unwilling to participate to the biological investigations.

  24. Individual deprived of liberty or placed under legal protection.

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 Oulimata Diop - o.diop@rennes.unicancer.fr NC / NC Oui 11/03/2020
ANGERS - Institut de Cancérologie de l'Ouest Dr AUGEREAU Paule - - / À venir 20/12/2019
CAEN- Centre Unicancer F. BACLESSE Dr George EMILE - g.emile@baclesse.unicancer.fr - NC / NC Oui 09/01/2020
Afficher les détails
Acronyme : "DENIVOS P_2017_007 2018-001105-85 "
Spécialité : Pneumologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: Denosumab-nivolumab combination
Both drugs to be continued until progression or unacceptable toxicity and for a maximum of two years

Informations

Carcinome Bronchique non à petites cellules (CBNPC)

2ème ligne avancée, métastatique 

avec métastase osseuse

Phase: 2

Promoteur: Centre Hospitalier de la Région d'Annecy
Autre(s) acronyme(s): P_2017_007
2018-001105-85
Contact promoteur: Florence Ennahdi
Pascale Cony-Makhoul
Mail promoteur: fennahdi@ch-annnecygenevois.fr
pconymakhoul@ch-annecygenevois.fr
Tel promoteur: 33450537031/3345063643

-
Source: Clinical trial.gov 2019

Cet essai dans d'autres annuaires :

Titre :

A Multicenter Phase II Study Evaluating Denosumab (XGEVA®) in Combination With Nivolumab (OPDIVO®) as Second-line Therapy for Patients With Stage IV Non-small-Cell Lung Cancer (Squamous and Non-squamous) With Bone Metastases: DENIVOS STUDY

Critères d'inclusion :
  1. Cytologically or histologically proven stage IV NSCLC

  2. Patients who had received first-line platin salt-based chemotherapy and will be given second-line nivolumab;

  3. Patients with bone metastases, symptomatic or not, confirmed by X-rays, CT scan, MRI, PET-CT scan or technetium bone scintigraphy

  4. Presence of at least 1 measurable target lesion, according to RECIST criteria 1.1, in a non-irradiated site

  5. For non-squamous cell NSCLC, patients without activating epidermal growth factor receptor mutation, anaplastic lymphoma kinase (ALK) or reactive oxygen species (ROS)-1 translocation, or B‐Raf proto‐oncogene, serine/threonine kinase (BRAF V600) mutation

  6. PD-L1 status known and expressed as a percentage of tumor cells; assessed at the diagnosis or the more recent PD-L1 expression status available.

  7. Eastern Cooperative Oncology Group Performance Status 0/1

  8. Estimated life-expectancy ≥12 weeks

  9. No prior malignant tumor during the previous 5 years, except for in situ carcinomas of the cervix or basal or squamous cell carcinomas of the skin adequately treated;

  10. Adequate organ function determined by laboratory analyses less than 7 days before inclusion:

    Normal hepatic function: bilirubin < 1.5× normal (N), alanine aminotransferase and aspartate aminotransferase <2.5× N or <5× N if hepatic metastases are present

    Renal function (renal clearance of creatinine at least ≥45 mL/min)

    Hematological function: absolute number of neutrophils ≥1.5×109/L and/or platelets ≥100×109/L, hemoglobin ≥8 g/dL

  11. Women of child-bearing age must use an effective contraceptive method and mechanical contraception during and up to 6 months after the end of treatment;

  12. Men must use effective contraception during and up to 6 months after the treatment period

  13. Subjects with cerebral metastases may be enrolled, provided that all lesions are controlled, and adequately treated by radiotherapy (stereotactic or not), craniotomy, or gamma knife therapy, with no evidence of progression, and have not required steroids for at least 2 months prior to enrolment. Carcinomatous meningitis is excluded regardless of clinical stability

  14. Subjects must have signed and dated an approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care

  15. Patient affiliated or benefitting from the French national health insurance program

Critères de non-inclusion :
  1. Patients previously treated with bisphosphonates and/or denosumab

  2. Patients previously treated with immunotherapy

  3. Patients with symptomatic cerebral metastases

  4. Contraindication to nivolumab use:

    Prior autoimmune disease(s), define as disease required systemic treatment in the past (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

    Prior diffuse interstitial pneumopathy

    Systemic immunosuppressive therapy; define as steroid medication at a dose greater than prednisone 10 mg/day or equivalent. For patients with mismatch repair-deficient high-grade gliomas, concurrent steroid medication at a dose greater than prednisone 20mg/day or equivalent

  5. Contraindication for denosumab use:

    Poor dental status requiring immediate specialized management, like oral surgery

    Prior or current signs of osteonecrosis of the jaw/osteomyelitis

    Invasive dental intervention schedule during the study or not yet healed

  6. Patient with known sensitivity to any of the products to be administered during the study

  7. Concomitant administration of bisphosphonates

  8. Hypocalcemia or severe uncorrected hypercalcemia

  9. Medical or psychological condition preventing informed consent

  10. Pregnant or breastfeeding woman

  11. PD-L1-status results unavailable

  12. Simultaneous participation of the patient in another clinical research trial

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 4 / 3 Oui 21/01/2020
Afficher les détails

Fiche détaillée de l'essai