Actively Recruiting
Phase Ib/II Study of Cabozantinib Plus Dostarlimab in Women With Recurrent Gynecologic Carcinosarcoma
Led by University of Alabama at Birmingham · Updated on 2026-04-15
37
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a combination treatment for women with recurrent gynecologic carcinosarcoma, a type of cancer affecting female reproductive organs. This study explores the effects of combining Cabozantinib, a drug that blocks vascular endothelial growth factors (VEGF), with Dostarlimab, an immunotherapy drug. This combination is being studied to understand if it can improve the body's immune response against cancer, as VEGF inhibitors might help enhance the function of cells that present cancer antigens to the immune system. Participants will receive Cabozantinib at a dose of 40 mg taken orally every day along with Dostarlimab given intravenously at 500 mg every 3 weeks for the first four treatment cycles. After this initial phase, maintenance therapy will continue with Cabozantinib 40 mg daily and Dostarlimab 1000 mg every 6 weeks. This treatment will continue for up to two years or until disease progression or unacceptable side effects. During the study, women will be closely monitored through regular assessments to measure how long their cancer remains stable without worsening, specifically focusing on progression-free survival at 6 months. Participants will undergo laboratory tests to ensure adequate organ function and will be evaluated for side effects and overall health. The total duration of participation depends on individual response and treatment tolerance, with ongoing safety monitoring throughout the study period.
CONDITIONS
Brief 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 Grade 1 CTCAE v5.0 from prior treatment toxicities, unless clinically nonsignificant and stable
- ECOG Performance Status of 0-2
- Age 18 years or older
- Adequate organ and marrow function based on laboratory tests within 14 days before treatment
- Ability to understand and comply with the study protocol and provide informed consent
- Women of childbearing potential and their partners must agree to use accepted contraception during and 5 months after treatment
- Females must not breastfeed during the trial
- 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 treatment
- Use of cytotoxic, biologic, or systemic anticancer therapy within 4 weeks before treatment
- Radiation therapy to bone metastasis within 2 weeks or other radiation within 4 weeks before treatment
- Known brain metastases or cranial epidural disease unless treated and stable for 4 weeks
- Use of certain anticoagulants except specific allowed agents
- Abnormal blood clotting tests within 7 days before treatment
- Uncontrolled or significant recent illness including serious heart conditions, uncontrolled hypertension, recent stroke or thromboembolic event
- Gastrointestinal conditions with high risk of perforation or fistula
- Recent major or minor surgery without complete healing
- Corrected QT interval > 500 ms on ECG within 28 days before treatment
- Inability to swallow tablets
- Allergy or hypersensitivity to study drugs
- Diagnosis of another malignancy within 2 years except certain low-risk tumors
- Concurrent chemotherapy or radiation therapy
- Serious chronic or acute illness posing high risk
- Medical or psychological issues impairing protocol compliance
- Active infection including urinary tract infection, HIV, or viral hepatitis unless treated
- Live vaccine within 30 days before treatment
- History or evidence of certain lung diseases or autoimmune disorders
- Malabsorption syndrome
- Requirement for dialysis
- History of organ or stem cell transplant
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants receive cabozantinib by mouth daily and dostarlimab intravenously every 3 weeks for the first 4 cycles, followed by cabozantinib daily and dostarlimab every 6 weeks as maintenance therapy, for up to 2 years of treatment.
Regular intravenous dosing visits every 3 weeks for the first 4 cycles, then every 6 weeks for maintenance
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
M
Margaret A Thomas, MPH
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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