A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)

• Status: Recruiting
• Trial end date: 2029-12-31

Summary

Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +/- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma.

198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio.

1. Group A: Dostarlimab monotherapy

• First 3 cycles: Dostalimab 500mg every 3 weeks, IV

• 4 cycles ~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV

2. Group B: Dostarlimab + Bevacizumab combination therapy

• First 3 cycles: Dostalimab 500mg every 3 weeks, IV

• 4 cycles ~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV

• Bevacizumab administered IV at 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity

3. Group C: General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)

• Phase: Phase 2

Details

• Lead Sponsor: Yonsei University
• Treatments: Bevacizumab; Dostarlimab; Doxorubicin; Gemcitabine; Liposomal doxorubicin; Paclitaxel