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)
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: 1. Female patient is at least 18 years of age, 2. Patient has signed the Informed Consent (ICF) and is able to comply with protocol requirements. 3. Patient with histologically proven confirmed recurrent or persistent clear cell carcinoma of the ovary, endometrium, cervix, vagina, and vulva * Local review by gynecologic pathologist required * ≥50% clear cell histology in case of mixed carcinoma * WT-1 neg (Only in case of ovarian cancer) Note: In the case of including non-ovarian clear cell carcinoma with more than 20 cases, the decision is made through discussion with the SPONSOR. 4. Patient with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. Disease progression within 12 months of completing platinum-based chemotherapy 6. 1-5 prior lines of therapies 7. Patient with measurable disease according RECIST 1.1 criteria 8. Availability of Tumor tissue for translational research . - A formalin-fixed paraffin-embedded (FFPE) tumor bloc