Spots Global Cancer Trial Database for Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer
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Trial Identification
Brief Title: Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer
Official Title: A Phase 2 Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer
Study ID: NCT05502315
Study Description
Brief Summary: This is a multicenter, single-arm, two-stage open-label phase 2 study of the combination of cabozantinib + nivolumab in subjects with advanced castration-resistant prostate cancer (CRPC).
Detailed Description: Eligible subjects will undergo a baseline biopsy prior to treatment initiation. They will then initiate treatment with cabozantinib (40 mg orally daily) and nivolumab (480 mg intravenously every four weeks). An on-treatment biopsy will be performed during Cycle 2. Subjects will continue treatment until radiographic progression, toxicity or withdrawal. Prostate-specific antigen (PSA) levels will be evaluated once every cycle. Radiographic assessments will occur every two cycles for one year and then every three cycles thereafter. Cycle length is 28 days.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
University of California San Diego, La Jolla, California, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
University of Wisconsin, Madison, Wisconsin, United States
Contact Details
Name: Rana R. McKay, MD
Affiliation: University of California, San Diego
Role: PRINCIPAL_INVESTIGATOR
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