University of Alabama at Birmingham
Rebecca Arend
Immunotherapy has gained a significant amount of attention recently, but its efficacy as a single agent in gynecological cancers has been disappointing. Pre-clinical evidence supports the combination of using Vascular Endothelial Growth Factors (VEGF) inhibitors with immunotherapy. VEGF inhibitors suppress the activation of tumor-associated macrophages (TAMs) and VEGF has been shown to affect the functional maturation of dendritic cells; therefore, VEGF inhibitors could improve the function of antigen presentation. In this study, Cabozantinib (VEGF inhibitor) and Dostarlimab (immunotherapeutic drug) will be admnistered as a combination to patients with recurrent gynecologic carcinosarcoma.
Gynecologic Cancer
Carcinoma
Uterine Cancer
Endometrial Cancer
Cabo + Dostarlimab
Phase 1
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 37 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Phase Ib/II Single Arm Study of Cabozantinib Plus Dostarlimab in Women With Recurrent Gynecologic Carcinosarcoma |
Actual Study Start Date : | August 20, 2023 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Cabo + Dostarlimab Cabozantinib 40 mg by mouth every day + Dostarlimab 500 mg intravenous every 3 weeks followed by maintenance therapy: Cabozantinib 40 mg by mouth every day + Dostarlimab 1000 mg intravenous every 6 weeks |
Drug: Cabo + Dostarlimab |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
O'Neal Comprehensive Cancer Center at UAB
Birmingham, alabama, United States, 35294