Advanced small cell ovarian carcinoma of hypercalcemic type MedDRA version: 21.1 Level: PT Classification code 10070908 Term: Ovarian cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10070907 Term: Ovarian cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 1007090
Conditions
Sponsors
ARCAGY-GINECO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient who are at least 16 years of age on the day of signing informed consent with previously untreated, pathologically confirmed Small cell carcinoma of the ovary 2) Stage FIGO II 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: =65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: 1) SCCOHT stage I 2) 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). 3) Patients who has 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. 4) Patients who has had an allogenic tissue/solid organ transplant. 5) Patient who has received prior systemic anti-cancer therapy including investigational agents 6) Patients who has 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. 7) Patients who has 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. 8)Patients who has 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. 9) Patients who has severe hypersensitivity (Grade 3 or higher) to pembrolizumab and/or any of its excipients (refer to the IB for a list of excipients). 10) Patients who has 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). 11) Patients who has 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. 12) Patients who has a history of (non-infectious) pneumonitis/ interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease that requires steroids. 13) Has an active infection requiring systemic therapy. 14) Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority. 15) 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. 16) Has a known history of active tuberculosis (TB; Bacillus tuberculosis) 17) 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 treat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the complete response rate after perioperative treatment by chemotherapy and immunotherapy, using the RECIST 1.1;Secondary Objective: -To assess the safety profile of the combination immunotherapy and chemotherapy -To assess Progression-Free Survival (PFS) -To assess Overall Survival (OS) -To assess the Partial response rate at the end of first-sequence therapy -To assess the Duration of Response, according to RECIST 1.1 ;Primary end point(s): Complete response rate is documented using RECIST 1.1;Timepoint(s) of evaluation of this end point: After perioperative treatment by chemotherapy + immunotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Safety will be assessed using NCI CTC AEv5.0 • Progression Free Survival (PFS) will be computed from the start date of treatment to the date of progression or death. • Overall Survival (OS) will be defined from the start date of treatment to the date of death, whatever the cause. • Partial Response Rate at the end of first-sequence therapy • Duration of Response (DoR): the time from complete response is first met until the first objective documented progression, according to RECIST v1.1. ;Timepoint(s) of evaluation of this end point: • Safety will be assessed using NCI CTC AEv5.0 • Progression Free Survival (PFS) will be computed from the start date of treatment to the date of progression or death. • Overall Survival (OS) will be defined from the start date of treatment to the date of death, whatever the cause. • Partial Response Rate at the end of first-sequence therapy • Duration of Response (DoR): the time from complete response is first met until the first objective documented progression, according to RECIST v1.1. | — |
Countries
France
Contacts
Public ContactProject Manager
ARCAGY-GINECO
Outcome results
None listed