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
Parallel
Dostarlimab
DrugIntravenous (IV) infusion
Bevacizumab
DrugIntravenous (IV) infusion
Doxorubicin
DrugIntravenous (IV) infusion
Gemcitabine
DrugIntravenous (IV) infusion
Paclitaxel
DrugIntravenous (IV) infusion
Pegylated liposomal doxorubicin
DrugIntravenous (IV) infusion
Progression Free Survival
The time from the date of randomization until first documentation of disease progression, as determined by investigator assessment based on RECIST 1.1, or death due to any cause, whichever occurs first.
Objective Response Rate
the proportion of patients who have best overall response of either complete response (CR) or partial response (PR), as investigator assessment based on RECIST 1.1
Disease control rate
the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by investigator assessment per RECIST 1.1 . SD must be achieved at ≥ 7 weeks after randomization to be considered best overall response.
Clinical benefit rate
the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by investigator assessment per RECIST 1.1 . (duration of SD ≥ 23 weeks after randomization)
Progression Free Survival 2
the time from initial randomization to the second objective disease progression (ie, after the first subsequent therapy) or death.
Disease-related or Treatment-related Biomarkers
Translational research including NGS as well as MMRd, MSI-H, PD1/L1, TMB, Immune signature, and Tie-2.
Comparison of RECIST1.1 and i-RECIST assessment
By comparing RECIST 1.1 and iRECIST, evaluate the accuracy of iRECIST for assessing the therapeutic efficacy of ICIs.
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Yonsei University
Lead sponsor
GlaxoSmithKline
Collaborator
