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)

Sponsor
Yonsei University
Study ID
NCT06023862
Phase
PHASE2
Status
Recruiting
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Conditions

  • Clear Cell Carcinoma
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Uterine Cervical Neoplasms
  • Vagina Neoplasm
  • Vulvar Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab — DRUG
    Intravenous (IV) infusion
  • Bevacizumab — DRUG
    Intravenous (IV) infusion
  • Doxorubicin — DRUG
    Intravenous (IV) infusion
  • Gemcitabine — DRUG
    Intravenous (IV) infusion
  • Paclitaxel — DRUG
    Intravenous (IV) infusion
  • Pegylated liposomal doxorubicin — DRUG
    Intravenous (IV) infusion

Study Details

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)

Key Dates

Start date
Jan 22, 2024
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
198 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    Dostarlimab monotherapy
  • Experimental: Group B
    Dostarlimab + Bevacizumab combination therapy
  • Active Comparator: Group C
    General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)

Primary Outcome Measure

Progression Free Survival [ Time Frame: Up to approximately 48 months ]

Central Contacts

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