A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum… (NCT06023862) | Clinical Trial Compass
RecruitingPhase 2
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)
Australia, Hong Kong, Japan198 participantsStarted 2024-01-22
Plain-language 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)
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Female patient is at least 18 years of age,
✓. Patient has signed the Informed Consent (ICF) and is able to comply with protocol requirements.
✓. Patient with histologically proven confirmed recurrent or persistent clear cell carcinoma of the ovary, endometrium, cervix, vagina, and vulva
✓. Patient with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
✓. Disease progression within 12 months of completing platinum-based chemotherapy
✓. 1-5 prior lines of therapies
✓. Patient with measurable disease according RECIST 1.1 criteria
✓. Availability of Tumor tissue for translational research . - A formalin-fixed paraffin-embedded (FFPE) tumor block(preferred) or at least 20 slides (unstained, freshly cut, serial sections) must be submitted.
Exclusion criteria
✕. Patient has had ≥ 6 prior lines of chemotherapy. Surgery of the recurrence is allowed.
✕. Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
✕. 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.
✕. Patient with contraindication to chemotherapy or immune checkpoint inhibitor treatments or anti-angiogenic inhibitor
✕. Patients with uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥100 mmHg) based on an average of ≥ 3 BP readings on ≥ 2 sessions.
✕. Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
✕. Patients with current abdominal/pelvic fistula
✕. Patient has a concomitant malignancy, or patient has a prior non-gynecological malignancy who has been disease-free for \< 3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.