Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around
Principal Investigator
by Rana R. McKay, MD
Headshot of Rana R. McKay
Rana R. McKay

Description

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).

Official Title

A Phase 2 Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer

Details

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.

Keywords

Castration-resistant Prostate Cancer, Metastatic Cancer, Castration resistant prostate cancer, Immunotherapy, Targeted therapy, Bone metastases, Prostatic Neoplasms, Nivolumab, Cabozantinib

Eligibility

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States
  • University of Texas Southwestern Medical Center accepting new patients
    Dallas Texas 75390 United States
  • University of Wisconsin accepting new patients
    Madison Wisconsin 53705 United States
  • University of Chicago Medical Center accepting new patients
    Chicago Illinois 60637 United States

Lead Scientist at UCSD

  • Rana R. McKay, MD
    Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 328 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rana McKay, MD
ID
NCT05502315
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 47 study participants
Last Updated