Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer

Part of paid clinical trials in La Jolla, California.

Sponsor
Rana McKay, MD
Study ID
NCT05502315
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Castration-resistant Prostate Cancer
  • Metastatic Cancer

Eligibility Criteria

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

Interventions

Study Details

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).

Key Dates

First listed
Aug 16, 2022
Start date
Feb 2, 2023
Status verified
Jul 2026
Primary completion
Jul 12, 2026
Completion
Jul 12, 2027

Study Design

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

Arms

  • Experimental: Experimental Group
    40 mg of cabozantinib taken orally every day (days 1-28) of a 28 day cycle 480 mg of nivolumab given intravenously on the first day (day 1) of each 28 day cycle

Primary Outcome Measure

Radiographic Progression Free Survival (rPFS) [ Time Frame: 6 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093-
University of Chicago Medical CenterChicagoIllinois60637-
University of Texas Southwestern Medical CenterDallasTexas75390-
University of WisconsinMadisonWisconsin53705-

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