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 (May 2026). This Phase 2 trial studies multiple treatments for ovarian neoplasms.
Treatment: Dostarlimab · Bevacizumab · Doxorubicin · Gemcitabine · Paclitaxel · Pegylated liposomal doxorubicin — 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)
Check if I qualifyExtracted eligibility criteria
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)
Prior therapy
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.
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