NCT05502315

Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Rana McKay, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Castration-resistant Prostate Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Cabozantinib	40 mg taken orally
DRUG	Nivolumab	480 mg by infusion

Timeline

• Start date: 2023-02-02
• Primary completion: 2026-04-12
• Completion: 2027-04-12
• First posted: 2022-08-16
• Last updated: 2026-01-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study