Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial)

Conditions

• Metastatic Hormone Refractory Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cabozantinib — DRUG
  Supplied by Exelixis
• Nivolumab — DRUG
  Supplied by Bristol-Myers Squibb
• Abiraterone acetate — DRUG
  Commercially available
• Prednisone — DRUG
  Commercially available
• Peripheral blood collection — PROCEDURE
  Prior to start of treatment, after 8 weeks of combination therapy, with every subsequent imaging (every 12 weeks), end of treatment

Study Details

The goal of this study is to determine the recommended phase 2 dose of the multi-drug combination of abiraterone, cabozantinib, and nivolumab in conjunction with ongoing androgen deprivation therapy in previously untreated metastatic hormone-sensitive prostate cancer patients. The investigators hypothesize that the combination of cabozantinib and abiraterone acetate/prednisone in conjunction with nivolumab will have an acceptable safety profile and will be feasible to administer in patients with hormone-sensitive metastatic prostate cancer.

Key Dates

Start date

Feb 19, 2021

Status verified

Nov 2025

Primary completion

Sep 9, 2021

Completion

Sep 10, 2025

Study Design

Enrollment

18 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Level 1: Cabozantinib+Abiraterone acetate +Nivolumab
  -Abiraterone acetate is an oral medication given at a dose of 1000 mg daily. Prednisone is an oral medication given at a dose of 5 mg daily. Nivolumab is given intravenously over 30 minutes on Day 1 of each 28-day cycle at a dose of 480 mg. Cabozantinib is an oral drug given daily; dosing will be 20 mg. Participants can continue to receive treatment for up to 2 years.
• Experimental: Level 2: Cabozantinib+Abiraterone acetate +Nivolumab
  -Abiraterone acetate is an oral medication given at a dose of 1000 mg daily. Prednisone is an oral medication given at a dose of 5 mg daily. Nivolumab is given intravenously over 30 minutes on Day 1 of each 28-day cycle at a dose of 480 mg. Cabozantinib is an oral drug given daily; dosing will be 40 mg. Participants can continue to receive treatment for up to 2 years.
• Experimental: Expansion: Cabozantinib+Abiraterone acetate +Nivolumab
  -Abiraterone acetate is an oral medication given at a dose of 1000 mg daily. Prednisone is an oral medication given at a dose of 5 mg daily. Nivolumab is given intravenously over 30 minutes on Day 1 of each 28-day cycle at a dose of 480 mg. Cabozantinib is an oral drug given daily; dosing will be dependent on recommended dose found in first part of study. Participants can continue to receive treatment for up to 2 years.

Primary Outcome Measure

Frequency of dose-limiting toxicities (DLTs) [ Time Frame: Completion of 1st cycle of treatment for patients in dose level 1 & dose level 2 (estimated to be 11 months) ]

Locations (1)

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