Study of Pembrolizumab Combination With Chemotherapy in Platinum-sensitive Recurrent Low-grade Serous Ovarian Cancer
NCT04575961 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2025-05-23
Summary
This is a phase II, single arm, multi-centre study to assess the efficacy of pembrolizumab in combination with platinum-based chemotherapy (investigator's choice: carboplatin + gemcitabine or carboplatin + pegylated liposomal doxorubicin) administered concurrent to chemotherapy and in maintenance, in patients with low grade ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) having platinum-sensitive relapse (platinum-free interval \> 6 months).
Conditions
- Ovarian Cancer
- Low Grade Serous Carcinoma
- Primary Peritoneal Carcinoma
- Fallopian Tube Cancer
Interventions
- DRUG
-
Participants receive pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles
Sponsors & Collaborators
- collaborator INDUSTRY
-
North Eastern German Society of Gynaecological Oncology
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-22
- Primary Completion
- 2026-03-01
- Completion
- 2028-03-01
Countries
- Germany
Study Locations
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