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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)

NCT06023862 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2026-05-06

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • JUNGYUN LEE, Ph.D. · Severance Hospital, Yonsei University Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2027-08-31
Completion
2029-12-31

Countries

  • Australia
  • Hong Kong
  • Japan
  • Singapore
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06023862 on ClinicalTrials.gov