Dostarlimab and Cobolimab in Advanced Cervical Cancer

Conditions

Dostarlimab — DRUG
Humanized monoclonal antibody, 50mg/mL type 1 borosilicate clear glass vial, via intravenous infusion per protocol.
Cobolimab — DRUG
Humanized anti-TIM-3 monoclonal antibody, 20mg/mL single-use vial, via intravenous infusion per protocol.

This research is being done to determine how effective dostarlimab in combination with cobolimab is in metastatic or recurrent cervical cancer.

Experimental: Cohort A: Immunotherapy Naive
10 Participants will complete study procedures as follows: * Baseline visit. * Imaging tests at baseline visit, at week 9, and then every 12 weeks. * Cycle 1 through End of Treatment (up to 2 years of treatment): • Day 1 of 21 Day cycle: Dostarlimab 1x daily and Cobolimab 1x daily. * End of Treatment visit with blood tests and imaging tests. * Follow Up Period: Every 3 months for 2 years and then every 6 months for an additional 5 years. Includes imaging tests. If \>= 2 participants with objective responses, then 19 additional participants will be enrolled.
Experimental: Cohort B: Immunotherapy Exposed
14 Participants will complete study procedures as follows: * Baseline visit. * Imaging tests at baseline visit, at week 9, and then every 12 weeks. * Cycle 1 through End of Treatment (up to 2 years of treatment): • Day of 21 Day cycle: Predetermined dose of Dostarlimab 1x daily. Predetermined dose of Cobolimab 1x daily. * End of Treatment visit with blood tests and imaging tests. * Follow Up Period: Every 3 months for 2 years and then every 6 months for an additional 5 years. Includes imaging tests. If \>= 2 participants with objective responses, then 23 additional participants will be enrolled.

Objective Response Rate (ORR) Based on irRECIST [ Time Frame: Up to 2 years ]

Facility	City	State	ZIP	Site coordinators
Beth Israel Deaconess Medical Center	Boston	Massachusetts	02215	-
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	-

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