Cabozantinib Plus Nivolumab and Ipilimumab in Women With Recurrent Gynecologic Carcinosarcoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: University of Alabama at Birmingham
Study ID: NCT04149275
Phase: PHASE2
Status: Withdrawn

Conditions

Carcinosarcoma of Ovary
Carcinosarcoma of Uterus
Carcinosarcoma of Vagina

Eligibility Criteria

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

Interventions

Cabozantinib — DRUG
Treatment with oral Cabozantinib once daily
Ipilimumab — DRUG
IV administration of Ipilimumab on 21 day cycles
Nivolumab — DRUG
IV administration of Nivolumab on 21 day cycles, followed by Nivolumab maintenance on 28 day cycles

Study Details

The purpose of this study is to test the safety of Cabozantinib in combination with Nivolumab and Ipilimumab and see what affects that this combination treatment has on those with recurrent carcinosarcomas.

Key Dates

Start date: Feb 28, 2021
Status verified: Feb 2021
Primary completion: Feb 28, 2021
Completion: Feb 28, 2021

Study Design

Enrollment: 0 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Cabozantinib + Nivolumab + Ipilimumab
All recurrent carcinosarcomas

Primary Outcome Measure

Percent progression free survival according to RECIST v1.1 [ Time Frame: Baseline through 6 months ]

Locations (1)

Facility	City	State	ZIP	Site coordinators
University of Alabama at Birmingham	Birmingham	Alabama	35233	-

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By research site

University of Alabama at Birmingham· Birmingham, AL