A Phase Ib/II Single Arm Study of Cabozantinib Plus Dostarlimab in Women With Recurrent Gynecologic Carcinosarcoma
University of Alabama at Birmingham
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically confirmed diagnosis of carcinosarcoma (independent of organ of gynecologic origin) 2. Received at least one prior chemotherapy regimen for their cancer 3. Must have measurable or evaluable lesion defined by iRECIST 4. Recovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy 5. ECOG Performance Status of 0-2 6. Age ≥ 18 years 7. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days befo…
Interventions
- DrugCabo + Dostarlimab
Combination of standard dose of cabozantinib and 500 mg dostarlimab for first 4 cycles followed by standard dose of cabozantinib and 1000 mg of dostarlimab until 2 years of treatment
Location
- O'Neal Comprehensive Cancer Center at UABBirmingham, Alabama