Cabozantinib and Dostarlimab in Recurrent Gynecologic Carcinosarcoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05559879
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabo + Dostarlimab — DRUG
    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

Study Details

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.

Key Dates

Start date
Aug 20, 2023
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Progression-Free Survival at 6 months [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
O'Neal Comprehensive Cancer Center at UABBirminghamAlabama35294
Margaret Thomas, MPH
[email protected]
Michael Toboni, MD (PRINCIPAL_INVESTIGATOR)
Rebecca Arend, MD (SUB_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
O'Neal Comprehensive Cancer Center at UAB· Birmingham, AL

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