RecruitingPhase 2NCT06023862

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)

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)


Sponsor

Yonsei University

Enrollment

198 participants

Start Date

Jan 22, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing three treatment approaches for women with a rare gynecological cancer called recurrent clear cell carcinoma (found in the ovaries, uterus, cervix, vagina, or vulva). The three arms are: an immunotherapy drug alone (dostarlimab), immunotherapy plus bevacizumab (a drug that cuts off blood supply to tumors), or standard chemotherapy. Clear cell carcinoma often doesn't respond well to regular chemo, making new approaches important. **You may be eligible if...** - You are a woman aged 18 or older - You have a confirmed diagnosis of recurrent clear cell carcinoma of the ovary, endometrium, cervix, vagina, or vulva - Your cancer progressed within 12 months of completing platinum-based chemotherapy - You have had 1 to 5 prior treatment regimens - You are otherwise healthy enough to participate (ECOG performance status 0 or 1) **You may NOT be eligible if...** - You have had 6 or more prior chemotherapy regimens - You have previously received immunotherapy drugs (anti-PD-1/PD-L1) - You have uncontrolled high blood pressure or active bleeding problems - You have active, uncontrolled brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDostarlimab

Intravenous (IV) infusion

DRUGBevacizumab

Intravenous (IV) infusion

DRUGDoxorubicin

Intravenous (IV) infusion

DRUGGemcitabine

Intravenous (IV) infusion

DRUGPaclitaxel

Intravenous (IV) infusion

DRUGPegylated liposomal doxorubicin

Intravenous (IV) infusion


Locations(18)

Kurume University Hospital

Kurume, Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Mie University Hospital

Tsu, Mie-ken, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Tokushima University Hospital

Tokushima, Tokushima, Japan

The Jikei University Hospital

Tokyo, Tokyo, Japan

The Cancer Institute Hospital Of JFCR

Tokyo, Tokyo, Japan

University of Tsukuba Hospital

Tsukuba, ㅊ Ibaraki, Japan

National University Hospital

Singapore, Singapore

Severance Hospital, Yonsei Health System

Seoul, Seoul, South Korea

National Cancer Center

Goyang-si, South Korea

Bundang Seoul National University Hospital

Seongnam-si, South Korea

Asan Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06023862


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