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Steroid Hormone Synthesis Inhibitor

Cabozantinib + Abiraterone + Immunotherapy for Prostate Cancer

Phase 1

Waitlist Available

Led By Russell K Pachynski, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence of metastatic disease on CT or MRI of the chest, abdomen, and pelvis, or technetium bone scan

Normal bone marrow and organ function as defined

Must not have

Prior treatment with cabozantinib

Prior exposure to second-generation androgen receptor inhibitors (e.g., enzalutamide, apalutamide, darolutamide)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completion of 1st cycle of treatment for patients in dose level 1 & dose level 2 (estimated to be 11 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat hormone-sensitive metastatic prostate cancer. The goal is to find the safe dosage and to see if the combination is feasible to administer.

Who is the study for?

This trial is for adults with hormone-sensitive prostate cancer that has spread, who haven't had chemotherapy or immunotherapy before. They should be on hormone therapy for no more than 12 weeks and agree to use contraception. Excluded are those with certain types of prostate cancer, prior treatments like cabozantinib, ongoing severe illnesses, active infections like hepatitis B/C or HIV, recent surgeries, or known brain metastases.

What is being tested?

The CABIOS Trial is testing a combination of drugs (cabozantinib and abiraterone acetate/prednisone) alongside nivolumab in patients continuing androgen deprivation therapy. The aim is to find the safest dose for phase 2 trials while assessing if this regimen can be safely given to men with advanced prostate cancer.

What are the potential side effects?

Potential side effects include high blood pressure from cabozantinib; liver issues from abiraterone; immune-related reactions such as inflammation in organs from nivolumab; fatigue; digestive problems; changes in blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My scans show cancer has spread to other parts of my body.

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My bone marrow and organs are functioning normally.

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My prostate cancer is confirmed to be sensitive to hormones.

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My testosterone levels are low due to treatment or surgery for cancer.

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I am 18 years old or older.

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My prostate cancer is confirmed to be sensitive to hormones.

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I am 18 years old or older.

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I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with cabozantinib before.

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I have been treated with advanced prostate cancer medications like enzalutamide.

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I do not have any other cancer that needs treatment right now.

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I haven't had major surgery in the last 2 weeks or minor surgery in the last 10 days.

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I do not have any severe illnesses that would make it unsafe for me to join the study.

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My prostate cancer is aggressive or resistant to hormone therapy.

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I have received chemotherapy for prostate cancer before.

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I cannot swallow pills.

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I do not have active hepatitis B, C, or HIV.

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I am not on any strong medications that affect liver enzymes.

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I have or had an autoimmune or inflammatory disorder.

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I have received an organ transplant from another person.

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I have previously received immunotherapy treatments.

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I have previously been treated with medications like abiraterone.

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I am currently taking blood thinners like warfarin or aspirin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of 1st cycle of treatment for patients in dose level 1 & dose level 2 (estimated to be 11 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completion of 1st cycle of treatment for patients in dose level 1 & dose level 2 (estimated to be 11 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of 1st cycle of treatment for patients in dose level 1 & dose level 2 (estimated to be 11 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of dose-limiting toxicities (DLTs)

Secondary study objectives

Disease free survival (DFS)

Disease specific survival (DSS)

Duration of response (DoR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Level 2: Cabozantinib+Abiraterone acetate +NivolumabExperimental Treatment5 Interventions

-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.

Group II: Level 1: Cabozantinib+Abiraterone acetate +NivolumabExperimental Treatment5 Interventions

-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.

Group III: Expansion: Cabozantinib+Abiraterone acetate +NivolumabExperimental Treatment5 Interventions

-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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Abiraterone acetate

2014

Completed Phase 3

~3440