Addition of Pembrolizumab to the Standard of Care Chemotherapy in Patient With SCCOHT

NCT04602377 | Recruiting Phase 2 DMC

• 1 other identifier: GINECO-OV243b
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Small Cell Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  CRR is defined as the proportion of patients who reached complete response (CR), according to RECIST v1.1 after the first sequence therapy including chemotherapy associated with immunotherapy and surgery.

  Around 4 to 6 months of the last patient included

Secondary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of pembrolizumab in combinaison with chemotherapy]

  30 days after the end of Cycle 6 (each cycle is 21 days)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of pembrolizumab in monotherapy]

  30 days after last treatment intake

• Progression Free Survival (PFS)

  from date of inclusion to date of event, assessed up to 5 years

• Overall Survival (OS)

  from date of inclusion to death, assessed up to 5 years

• Partial Response Rate (PRR)

  Around 4 to 6 months of the last patient included

Study Arms (1)

Pembrolizumab

EXPERIMENTAL

Single arm study

Drug: Pembrolizumab 25 MG/ML [Keytruda]

Interventions

Pembrolizumab 25 MG/ML [Keytruda] DRUG

Pembrolizumab (200mg flat dose) will be administred in combinaison with PAVEP chemotherapy for the first 6 cycles (21-day cycle) Then, Pembrolizumab (200mg flat dose) will be administred in monotherapy until one year for patients with complete response and up to two years for patients with Stable disease or Progression response after the end of first-sequence therapy (PAVEP chemotherapy +/- High dose chemotherapy) or until disease progression.

Also known as: MK-3475

Pembrolizumab

Eligibility Criteria

• Age: 12 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Stage FIGO I to IV classification
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• 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):

You may not qualify if:

• 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).
• 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.
• Patients who have had an allogenic tissue/solid organ transplant.
• 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).
• 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.
• 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.
• 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.
• 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).
• 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).
• 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.
• 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.
• Has an active infection requiring systemic therapy.

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (13)

ICO - Paul Papin

Angers, 49055, France

RECRUITING

Centre Hospitalier Universitaire d'Angers

Angers, 49933, France

ACTIVE NOT RECRUITING

Centre Hospitalier Régional Universitaire de Besançon

Besançon, 25030, France

ACTIVE NOT RECRUITING

Institut Bergonié

Bordeaux, 33076, France

ACTIVE NOT RECRUITING

Centre Georges François Leclerc

Dijon, 21079, France

ACTIVE NOT RECRUITING

Centre Oscar Lambret

Lille, 59020, France

ACTIVE NOT RECRUITING

CHU de Limoges - Hôpital Dupuytren

Limoges, 87042, France

RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

ICM Val d'Aurelle

Montpellier, 34298, France

WITHDRAWN

ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

RECRUITING

Hôpital de Hautepierre

Strasbourg, France

NOT YET RECRUITING

Oncopole Claudius Regaud - IUCT Oncopole

Toulouse, 31059, France

RECRUITING

Gustave Roussy

Villejuif, 94805, France

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Patricia PAUTIER, MD, PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Latifa BOUDALI

CONTACT

+33(0)-1-84-85-20-42; pembroSCCOHT@arcagy.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 26, 2020
• Study Start: August 4, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 1, 2030
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

FR (13)