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)
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
Local review by gynecologic pathologist required
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
Yonsei University
Lead sponsor
GlaxoSmithKline
Collaborator