Actively Recruiting
Addition of Pembrolizumab to the Standard of Care Chemotherapy in Patient With SCCOHT
Led by ARCAGY/ GINECO GROUP · Updated on 2025-11-28
27
Participants Needed
13
Research Sites
443 weeks
Total Duration
On this page
Sponsors
A
ARCAGY/ GINECO GROUP
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Addition of Pembrolizumab to the Standard of Care Chemotherapy in Patient With SCCOHT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 years or older with previously untreated, pathologically confirmed small cell carcinoma of the ovary
- May start treatment after one cycle of chemotherapy but must begin study treatment within 4 weeks of first chemotherapy cycle
- Disease stage FIGO I to IV
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow function with specified blood count levels
- Adequate liver and kidney function within defined laboratory limits
- Normal or controlled thyroid function
- Left ventricular ejection fraction over 55% measured by heart imaging
- Written informed consent provided before any study procedures
- Covered by medical insurance
- Willingness to comply with study procedures and availability for study duration
- Negative pregnancy test within 72 hours before treatment for women of childbearing potential
- Use of effective contraception during study and for specified periods after treatment
You will not qualify if you...
- Prior treatment with chemotherapy or immunotherapy (anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune agents) for this disease beyond one cycle of platinum-based chemotherapy
- Live vaccine received within 30 days before first study drug dose
- History of allogenic tissue or solid organ transplant
- Known immunodeficiency or recent immunosuppressive therapy
- Active or recent additional malignancy requiring treatment within past 5 years, except certain non-invasive cancers
- Contraindications to cisplatin, adriamycin, vepeside, or cyclophosphamide
- Severe hypersensitivity to pembrolizumab or any study chemotherapy agents
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Known HIV infection
- History of hepatitis B or active hepatitis C infection
- Active tuberculosis
- Any condition or therapy that could interfere with study participation
- Psychiatric or substance abuse disorder interfering with cooperation
- Breastfeeding women
- Participation in another clinical trial with investigational product within 30 days prior to or during this study and 30 days after treatment end
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
ICO - Paul Papin
Angers, France, 49055
Actively Recruiting
2
Centre Hospitalier Universitaire d'Angers
Angers, France, 49933
Active, Not Recruiting
3
Centre Hospitalier Régional Universitaire de Besançon
Besançon, France, 25030
Active, Not Recruiting
4
Institut Bergonié
Bordeaux, France, 33076
Active, Not Recruiting
5
Centre Georges François Leclerc
Dijon, France, 21079
Active, Not Recruiting
6
Centre Oscar Lambret
Lille, France, 59020
Active, Not Recruiting
7
CHU de Limoges - Hôpital Dupuytren
Limoges, France, 87042
Actively Recruiting
8
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
9
ICM Val d'Aurelle
Montpellier, France, 34298
Withdrawn
10
ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, France, 67033
Actively Recruiting
11
Hôpital de Hautepierre
Strasbourg, France
Not Yet Recruiting
12
Oncopole Claudius Regaud - IUCT Oncopole
Toulouse, France, 31059
Actively Recruiting
13
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
L
Latifa BOUDALI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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