RecruitingPhase 1Phase 2NCT05559879

Cabozantinib and Dostarlimab in Recurrent Gynecologic Carcinosarcoma

A Phase Ib/II Single Arm Study of Cabozantinib Plus Dostarlimab in Women With Recurrent Gynecologic Carcinosarcoma


Sponsor

University of Alabama at Birmingham

Enrollment

37 participants

Start Date

Aug 20, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — cabozantinib (a targeted therapy) and dostarlimab (an immunotherapy) — for people with recurrent gynecologic carcinosarcoma, a rare and aggressive cancer that can arise in the uterus, ovaries, or other gynecologic organs. **You may be eligible if:** - You have been diagnosed with gynecologic carcinosarcoma confirmed by biopsy - You have received at least one prior chemotherapy regimen for this cancer - You have measurable or evaluable disease - You are in reasonably good health (ECOG performance status 0–2) - You are 18 or older with adequate organ function (blood counts, liver, kidneys) **You may NOT be eligible if:** - You have uncontrolled high blood pressure or active liver disease - You have significant bleeding problems or blood clotting disorders - You have active autoimmune disease requiring treatment - You are pregnant or breastfeeding - You have had prior treatment with cabozantinib or a similar drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

O'Neal Comprehensive Cancer Center at UAB

Birmingham, Alabama, United States

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NCT05559879


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