Addition of Pembrolizumab to the Standard of Care Chemotherapy in Patient With SCCOHT
ConditionSmall Cell Ovarian Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age12+
SponsorARCAGY/ GINECO GROUP
About this trial
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.
Eligibility criteria
Qualifiers
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
Adequate marrow function
Disqualifiers
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.
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).
Trial design
Treatments tested in this trial
- Pembrolizumab 25 MG/ML [Keytruda]
Treatment groups
27 Participants
are divided into 1 treatment groupSponsors and collaborators
ARCAGY/ GINECO GROUP
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov