CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 198 target
Drug / intervention
Dostarlimab +5 moredrug
Likely dose
Not stated in record
Key inclusion· 12
  • Female patient at least 18 years old
  • Histologically confirmed recurrent or persistent clear cell carcinoma of ovary, endometrium, cervix, vagina, or vulva
  • ≥50% clear cell histology in mixed carcinoma; local gynecologic pathologist review required
  • WT-1 negative for ovarian cancer cases only
Key exclusion· 19
  • ≥6 prior lines of chemotherapy
  • Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • Prior anticancer therapy within 21 days or <5 times half-life, whichever is shorter
  • Contraindication to chemotherapy, immunotherapy, or anti-angiogenic therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06023862
NCT06023862Phase 2RecruitingOn Track

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)

Yonsei University·interventional·Posted Sep 5, 2023·Updated May 6, 2026

In Brief

A Phase 2 clinical trial evaluating Dostarlimab, Bevacizumab, and 4 other interventions for Ovarian Neoplasms and 5 related conditions. Currently recruiting, targeting 198 participants across 27 sites in 7 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Hong Kong, Japan, Singapore, South Korea, Taiwan, United Kingdom
CollaboratorsGlaxoSmithKline

Timeline

Phase 2Recruiting
2024202520262027202820292030
First PostedSep 5, 2023
Enrollment StartJan 22, 2024
Primary CompletionAug 31, 2027
Study CompletionDec 31, 2029
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 2.8 years agoPrimary completion in 1.2 years

Interventions

Dostarlimabdrug

Intravenous (IV) infusion

Bevacizumabdrug

Intravenous (IV) infusion

Doxorubicindrug

Intravenous (IV) infusion

Gemcitabinedrug

Intravenous (IV) infusion

Paclitaxeldrug

Intravenous (IV) infusion

Pegylated liposomal doxorubicindrug

Intravenous (IV) infusion