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OncoMatch/Clinical Trials/NCT06023862

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)

Is NCT06023862 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for ovarian neoplasms.

Phase 2RecruitingYonsei UniversityNCT06023862Data as of Jun 2026Location: Japan · Singapore · South Korea

Treatment: Dostarlimab · Bevacizumab · Doxorubicin · Gemcitabine · Paclitaxel · Pegylated liposomal doxorubicinMulticenter, 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)

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Dostarlimab

Targeted therapy

Bevacizumab

Chemotherapy

DoxorubicinGemcitabinePaclitaxelPegylated liposomal doxorubicin

Cancer type

Ovarian Cancer

Endometrial Cancer

Cervical Cancer

Biomarker criteria

Required: WT1 wild-type (negative)

WT-1 neg (Only in case of ovarian cancer)

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Female only

Prior therapy

Max 5 prior lines
Min 1 prior line

Must have received: platinum-based chemotherapy

Disease progression within 12 months of completing platinum-based chemotherapy

Cannot have received: chemotherapy

Patient has had ≥ 6 prior lines of chemotherapy

Cannot have received: anti-PD-1 therapy

Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

Cannot have received: anti-PD-L1 therapy

Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

Cannot have received: anti-PD-L2 therapy

Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

Cannot have received: anticancer therapy

Exception: Palliative radiation therapy to a small field ≥ 1 week prior to Day 1 of study treatment may be allowed after discussion with the SPONSOR.

Patient has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy) within 21 days or < 5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter.

Lab requirements

Blood counts

absolute neutrophil count ≥ 1,500 cells/μl; platelets ≥ 100,000 cells/μl; hemoglobin ≥ 9 g/dl or ≥ 5.6 mmol/l

Kidney function

serum creatinine ≤ 1.5× uln or calculated creatinine clearance ≥ 50 ml/min using the cockcroft-gault equation for patients with creatinine levels > 1.5× institutional uln

Liver function

total bilirubin ≤ 1.5× uln (≤ 2.0 x uln in patients with known gilbert's syndrome) or direct bilirubin ≤ 1× uln; ast and alt ≤ 2.5× uln unless liver metastases are present, in which case they must be ≤ 5× uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06023862 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior chemotherapy, anti-PD-1 therapy, anti-PD-L1 therapy disqualifies patients from enrollment.

Does this trial require WT1?

Yes, WT1 wild-type is a required biomarker for enrollment.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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