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

Sponsor
ARCAGY/ GINECO GROUP
Study ID
NCT04602377
Phase
PHASE2
Status
Recruiting
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Conditions

  • Small Cell Ovarian Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
12 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 4, 2021
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Feb 28, 2030

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab
    Single arm study

Primary Outcome Measure

Complete response rate [ Time Frame: Around 4 to 6 months of the last patient included ]

Central Contacts