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DOVENCT06023862

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)

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints: details revised at 2 of 9 entries
    • Site details revised at 27 of 27 sites
    • Publications: details revised at 1 of 1 entry
  2. Study sites: 18 to 27v7
  3. Study sites: 9 to 18v6
  4. Study sites: 8 to 9
    • Collaborators expanded, about 1 word
    v5
  5. Study sites: 7 to 8v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 7
    v3
  2. Start date: Sep 25, 2023 to Jan 22, 2024
    • Interventions: Bevacizumab (Drug), Dostarlimab (Drug), Doxorubicin (Drug), Gemcitabine (Drug), Paclitaxel (Drug) to Bevacizumab (Drug), Dostarlimab (Drug), Doxorubicin (Drug), Gemcitabine (Drug), Paclitaxel (Drug), Pegylated liposomal doxorubicin (Drug)
    • Eligibility criteria shortened, about 11 words
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Progression Free Survival
Timeframe: Up to approximately 48 months

Secondary (9)

Objective Response Rate
Disease control rate
Clinical benefit rate
Progression Free Survival 2
Overall survival
Show 4 moreShow less
Duration of Response Rate
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time to first and second Subsequent Treatment
Response rate of subsequent therapies

Arms and interventions

Group AExperimental

Dostarlimab monotherapy

Group BExperimental

Dostarlimab + Bevacizumab combination therapy

Group CActive comparator

General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)

Drugs: Dostarlimab, Bevacizumab, Doxorubicin, Gemcitabine, Paclitaxel, Pegylated liposomal doxorubicin

Sites

27 sites in 7 countries

Japan 10, South Korea 7, Australia 3, Taiwan 3, Singapore 2, Hong Kong 1, United Kingdom 1