Study of Pembrolizumab Combination With Chemotherapy in Platinum-sensitive Recurrent Low-grade Serous Ovarian Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Fallopian Tube Cancer
- Low Grade Serous Carcinoma
- Ovarian Cancer
- Primary Peritoneal Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
In this study, we will evaluate efficacy and safety of pembrolizumab in combination with chemotherapy (physician's choice) in subjects with low-grade ovarian cancer. Patients will receive Pembrolizumab 200mg q3w until progression or unacceptable toxicity, for a maximum of 35 cycles PLUS one of the f...
In this study, we will evaluate efficacy and safety of pembrolizumab in combination with chemotherapy (physician's choice) in subjects with low-grade ovarian cancer. Patients will receive Pembrolizumab 200mg q3w until progression or unacceptable toxicity, for a maximum of 35 cycles PLUS one of the following standard chemotherapies for LGSOC (investigators' choice): Carboplatin AUC 4 + Gemcitabine 1000mg/m² (q3w for 3-6 cycles) or Carboplatin AUC 5 + pegylated liposomal Doxorubicin 30mg/m² (q4w for 3-6 cycles) or Carboplatin AUC 5 monotherapy (q3w for 3-6 cycles). As primary objective 6-month progression free survival (PFS) rate will be analysed. About 2 sites in Germany will participate in this study to recruit 29 patients in 24 months.
Tracking Information
- NCT #
- NCT04575961
- Collaborators
- Merck Sharp & Dohme Corp.
- Investigators
- Not Provided
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