NCT06023862: DOVE

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)

Recruiting now Phase 2 Last updated 15 June 2025

What this trial tests

Phase 2 trial testing Dostarlimab in Ovarian Neoplasms in 198 participants. Currently enrolling.

Timeline

22 January 2024

Primary endpoint
31 August 2027

31 December 2029

Quick facts

Lead sponsor	Yonsei University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	198
Start date	22 January 2024
Primary completion	31 August 2027
Estimated completion	31 December 2029
Sites	18 locations across Singapore, Japan, South Korea

Drugs / interventions tested

• Dostarlimab
• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
• Doxorubicin
• Gemcitabine (gemcitabine) — full drug profile →
• Paclitaxel — full drug profile →
• Pegylated liposomal doxorubicin

Conditions studied

• Ovarian Neoplasms — all drugs for Ovarian Neoplasms →
• Endometrial Neoplasms — all drugs for Endometrial Neoplasms →
• Uterine Cervical Neoplasms — all drugs for Uterine Cervical Neoplasms →
• Vulvar Cancer — all drugs for Vulvar Cancer →

Sponsor

Yonsei University

Who can join

18 and older, female only, with Ovarian Neoplasms or Endometrial Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ovarian clear cell carcinoma: open questions on the management and treatment algorithm.
   Rosso R, Turinetto M, Borella F, Chopin N, et al · · 2025 · cited 10× · PMID 39846983 · DOI 10.1093/oncolo/oyae325
2. Phase II randomized study of dostarlimab alone or with bevacizumab versus non-platinum chemotherapy in recurrent gynecological clear cell carcinoma (DOVE/APGOT-OV7/ENGOT-ov80).
   Lee JY, Tan D, Ray-Coquard I, Lee JB, et al · · 2025 · cited 7× · PMID 39710508 · DOI 10.3802/jgo.2025.36.e51
3. Targeted therapies in primary vaginal cancer.
   Padrón LT, Schröder C, Marinova M, Thiesler T, et al · · 2025 · PMID 40784918 · DOI 10.1007/s00432-025-06267-x