Informations générales (source: ClinicalTrials.gov)
Multicentric Non-randomized Phase II of Pembrolizumab in Combination With Etoposide-cisplatin-based Chemotherapy in First-line Small Cell Ovarian Carcinoma of Hypercalcemic Type (PembroSCCOHT)
Interventional
Phase 2
ARCAGY/ GINECO GROUP (Voir sur ClinicalTrials)
août 2021
février 2030
04 juillet 2025
Small cell ovarian carcinomas are rare and have a very poor prognosis affecting a young
population. The objective of this study is to increase the efficacy of the initial
chemotherapy by providing immunotherapy and to be able to offer to more patients the
possibility of benefiting from an intensification of chemotherapy, which is a major
prognostic factor in this population.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Patricia PAUTIER | 22/02/2024 09:55:15 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Georges François Leclerc - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional Universitaire de Besançon - 25030 - Besançon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire d'Angers - 49933 - Angers - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59020 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU de Limoges - Hôpital Dupuytren - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| ICANS - Institut de cancérologie Strasbourg Europe - 67033 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| ICM Val d'Aurelle - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| ICO - Paul Papin - 49055 - Angers - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Oncopole Claudius Regaud - IUCT Oncopole - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
Inclusion Criteria:
1. Patient who are at least 12 years of age on the day of signing informed consent with
previously untreated, pathologically confirmed Small cell carcinoma of the
ovary.Patients could be included after one cycle of chemotherapy but have to start
treatment within 4 weeks after the first cycle of chemotherapy. They will start the
scheme at cycle 2.
2. Stage FIGO I to IV classification
3. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
4. Have adequate organ function:
- Adequate marrow function
- White blood cell (WBC) >2000/mm3 (stable off any growth factor within 4
weeks of first study drug administration)
- Neutrophils >1500/ mm3 (stable off any growth factor within 4 weeks of
first study drug administration)
- Platelets > 100 × 103/mm3 (transfusion to achieve this level is not
permitted within 2 weeks of first study drug administration)
- Haemoglobin > 9 g/dL (transfusion to achieve this level is not permitted
within 2 weeks of first study drug administration)
- Adequate other organ functions
- ALT and AST < 3× institutional ULN
- Total bilirubin < 1.5× institutional ULN (except Gilbert Syndrome: < 3.0
mg/dL)
- Normal thyroid function, subclinical hypothyroidism (thyroid-stimulating
hormone [TSH] < 10 mIU/mL) or have controlled hypothyroidism on
appropriate thyroid supplementation
- Left ventricular ejection fraction (LVEF) > 55 % measured by ECHO
(preferred) or MUGA scans
- Serum creatinine < 2× ULN or creatinine clearance (CrCl) > 60 mL/min
(measured using the Cockcroft-Gault formula below):
5. The participant (or legally acceptable representative if applicable) provides
written informed consent for the trial, prior to any study-specific procedure. The
participant may also provide consent for (140 - age in years) × weight in kg × 0.85
Female CrCl = 72 × serum creatinine in mg/dL GINECO-OV243b - PembroSCCOHT - Protocol
- Version 1.2 - 10/09/2020 Page 7 sur 83 Future Biomedical Research. However,
participant may participate in the main trial without participating in Future
Biomedical Research.
6. Covered by a medical insurance
7. Stated willingness to comply with all study procedures and availability for the
duration of the study
8. Women of childbearing potential must have a negative serum or urine pregnancy test
within 72 hours prior to treatment allocation
9. For females of reproductive potential: use of highly effective contraception
throughout the study period up to 120 days after the last dose of pembrolizumab and
180 days following the end of chemoradiotherapy (if applicable).
1. Patient who are at least 12 years of age on the day of signing informed consent with
previously untreated, pathologically confirmed Small cell carcinoma of the
ovary.Patients could be included after one cycle of chemotherapy but have to start
treatment within 4 weeks after the first cycle of chemotherapy. They will start the
scheme at cycle 2.
2. Stage FIGO I to IV classification
3. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
4. Have adequate organ function:
- Adequate marrow function
- White blood cell (WBC) >2000/mm3 (stable off any growth factor within 4
weeks of first study drug administration)
- Neutrophils >1500/ mm3 (stable off any growth factor within 4 weeks of
first study drug administration)
- Platelets > 100 × 103/mm3 (transfusion to achieve this level is not
permitted within 2 weeks of first study drug administration)
- Haemoglobin > 9 g/dL (transfusion to achieve this level is not permitted
within 2 weeks of first study drug administration)
- Adequate other organ functions
- ALT and AST < 3× institutional ULN
- Total bilirubin < 1.5× institutional ULN (except Gilbert Syndrome: < 3.0
mg/dL)
- Normal thyroid function, subclinical hypothyroidism (thyroid-stimulating
hormone [TSH] < 10 mIU/mL) or have controlled hypothyroidism on
appropriate thyroid supplementation
- Left ventricular ejection fraction (LVEF) > 55 % measured by ECHO
(preferred) or MUGA scans
- Serum creatinine < 2× ULN or creatinine clearance (CrCl) > 60 mL/min
(measured using the Cockcroft-Gault formula below):
5. The participant (or legally acceptable representative if applicable) provides
written informed consent for the trial, prior to any study-specific procedure. The
participant may also provide consent for (140 - age in years) × weight in kg × 0.85
Female CrCl = 72 × serum creatinine in mg/dL GINECO-OV243b - PembroSCCOHT - Protocol
- Version 1.2 - 10/09/2020 Page 7 sur 83 Future Biomedical Research. However,
participant may participate in the main trial without participating in Future
Biomedical Research.
6. Covered by a medical insurance
7. Stated willingness to comply with all study procedures and availability for the
duration of the study
8. Women of childbearing potential must have a negative serum or urine pregnancy test
within 72 hours prior to treatment allocation
9. For females of reproductive potential: use of highly effective contraception
throughout the study period up to 120 days after the last dose of pembrolizumab and
180 days following the end of chemoradiotherapy (if applicable).
1. Prior therapy for the disease with chemotherapy and/or 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 (eg, CTLA-4, OX-40, CD137).
2. Patients who have received a live vaccine within 30 days prior to the first dose of
study drug.
Examples of live vaccines include, but are not limited to, the following: measles,
mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus
Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for
injection are generally killed virus vaccines and are allowed; however, intranasal
influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not
allowed. Inactivated rabies vaccines are allowed.
3. Patients who have had an allogenic tissue/solid organ transplant.
4. Patient who has received more than one cycle of platinum-based chemotherapy, or any
prior systemic anti-cancer therapy including investigational agents for the SCCOHT.
(Patients could be included after one cycle of platinum-based therapy).
5. Patients who have a known diagnosis of immunodeficiency or is receiving chronic
systemic steroid therapy (in dosing exceeding 10 mg prednisone daily or equivalent)
or any other form of immunosuppressive therapy within 7 days prior the first dose of
study drug.
6. Patients who have a known additional malignancy that is progressing or has required
active treatment within the past 5 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of
the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma,
cervical cancer in situ) that have undergone potentially curative therapy are not
excluded.
7. Patients who have a contraindication to any component of cisplatin, adriamycine,
vepeside and cyclophosphamide.
Note: Investigators must use the local label for contraindications, prohibited
medications, and precautions for use.
8. Patients who have severe hypersensitivity (Grade 3 or higher) to pembrolizumab
and/or any of its excipients (refer to the IB for a list of excipients).
9. Patients who have a known severe hypersensitivity (Grade 3 or higher) to any of the
study chemotherapy agents and/or to any of their excipients (refer to the approved
product label(s) for a list of excipients).
10. Patients who have an active autoimmune disease that has required systemic treatment
in past 2 years (ie, 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) is not considered a form of systemic treatment and is allowed.
11. Patients who have a history of (non-infectious) pneumonitis/ interstitial lung
disease that required steroids or has current pneumonitis / interstitial lung
disease that requires steroids.
12. Has an active infection requiring systemic therapy.
13. Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is
not required unless mandated by local health authority.
14. Has a history of hepatitis B (defined as hepatitis B surface antigen [HBsAg]
reactive) or active hepatitis C virus (defined as HCV RNA [qualitative] is detected)
infection.
15. Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
16. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
participant's participation for the full duration of the study, or is not in the
best interest of the participant to participate, in the opinion of the treating
investigator.
17. Has a known psychiatric or substance abuse disorder that would interfere with
cooperating with the requirements of the study.
18. Breastfeeding women
19. Participation in another clinical study with an investigational product 30 days
prior and during the treatment course, and 30 days after end of treatment.