A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV07/ ENGOT-ov80 Study)

What this Trial Is About

Researchers are evaluating the effects of Dostarlimab alone or combined with Bevacizumab compared to standard nonplatinum chemotherapy in women with recurrent gynecological clear cell carcinoma, including cancers of the ovary, endometrium, cervix, vagina, and vulva. This phase II, randomized, open-label study aims to understand which treatment approach may better control disease progression and improve outcomes in this patient population. Participants will be divided into three groups: Group A receives Dostarlimab alone with an initial dosing of 500 mg every 3 weeks for 3 cycles, followed by 1000 mg every 6 weeks for up to 24 months. Group B receives the same Dostarlimab schedule plus Bevacizumab at 15 mg/kg every 3 weeks until disease progression or unacceptable side effects. Group C receives general chemotherapy with one of the drugs Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, or Gemcitabine. All treatments are given intravenously. During the study, participants will be monitored for disease progression, with the primary measure being progression-free survival for up to about 48 months. Secondary outcomes include response rates, disease control, overall survival, and safety over up to 72 months. Tumor tissue samples will be collected for research, and participants will undergo regular evaluations including imaging and laboratory tests. The study follows patients for a long period to assess treatment effects and safety.

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)