Trials / Recruiting
RecruitingNCT06023862
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)
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 198 (estimated)
- Sponsor
- Yonsei University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
- Ovarian Neoplasms
- Endometrial Neoplasms
- Uterine Cervical Neoplasms
- Vulvar Cancer
- Vagina Neoplasm
- Clear Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dostarlimab | Intravenous (IV) infusion |
| DRUG | Bevacizumab | Intravenous (IV) infusion |
| DRUG | Doxorubicin | Intravenous (IV) infusion |
| DRUG | Gemcitabine | Intravenous (IV) infusion |
| DRUG | Paclitaxel | Intravenous (IV) infusion |
| DRUG | Pegylated liposomal doxorubicin | Intravenous (IV) infusion |
Timeline
- Start date
- 2024-01-22
- Primary completion
- 2027-08-31
- Completion
- 2029-12-31
- First posted
- 2023-09-05
- Last updated
- 2025-06-15
Locations
18 sites across 3 countries: Japan, Singapore, South Korea
Source: ClinicalTrials.gov record NCT06023862. Inclusion in this directory is not an endorsement.