Actively Recruiting
Cabozantinib and Dostarlimab in Recurrent Gynecologic Carcinosarcoma
Led by University of Alabama at Birmingham · Updated on 2026-04-15
37
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cabozantinib and Dostarlimab in Recurrent Gynecologic Carcinosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of carcinosarcoma of gynecologic origin
- Received at least one prior chemotherapy regimen for cancer
- Measurable or evaluable lesion defined by iRECIST
- Recovery to baseline or 4 Grade 1 CTCAE v5.0 from prior treatment toxicities unless stable on supportive therapy
- ECOG Performance Status of 0-2
- Age 18 years or older
- Adequate organ and marrow function based on specific laboratory criteria within 14 days before first dose
- Able to understand and comply with protocol requirements and signed informed consent
- Women of childbearing potential and their partners agree to use accepted contraception during and 5 months after study
- Female patients must not breastfeed during treatment
- Female patients of childbearing potential must not be pregnant at screening
You will not qualify if you...
- Prior treatment with cabozantinib
- Use of any small molecule kinase inhibitor within 2 weeks or 5 half-lives before first dose
- Cytotoxic, biologic, or systemic anticancer therapy within 4 weeks before first dose
- Radiation therapy for bone metastasis within 2 weeks or other radiation within 4 weeks before first dose
- Known brain metastases or cranial epidural disease unless treated and stable for at least 4 weeks
- Use of certain anticoagulants except allowed low-dose aspirin or stable LMWH and factor Xa inhibitors without bleeding complications
- Prothrombin time (PT)/INR or PTT test 4 1.3 times ULN within 7 days before first dose
- Uncontrolled or significant cardiac, gastrointestinal, bleeding, pulmonary, or other disorders that increase risk
- Major surgery within 2 weeks or minor surgery within 10 days before first dose without complete healing
- QTcF interval > 500 ms on ECG within 28 days before first dose
- Inability to swallow tablets
- Allergy or hypersensitivity to study treatment components
- Another malignancy within 2 years except certain skin cancers or low-grade tumors
- Concurrent cytotoxic chemotherapy or radiation therapy
- Serious chronic or acute illness deemed high risk by investigator
- Medical or psychological conditions impairing protocol compliance
- Active infection including urinary tract infection, HIV, or viral hepatitis
- Live attenuated vaccine within 30 days before first dose
- History or evidence of pneumonitis, active autoimmune disease (with exceptions), malabsorption, dialysis requirement, or organ/stem cell transplant
AI-Screening
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Trial Site Locations
Total: 1 location
1
O'Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
M
Michael Toboni, MD, MSPH
CONTACT
M
Margaret A Thomas, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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