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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of dose-limiting toxicities (DLTs)
Secondary outcome measures
Disease free survival (DFS)
Disease specific survival (DSS)
Duration of response (DoR)
+5 moreTrial 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
Cabozantinib
2020
Completed Phase 2
~1080
Abiraterone acetate
2014
Completed Phase 3
~3440
Peripheral blood collection
2016
Completed Phase 1
~110
Prednisone
2014
Completed Phase 4
~2370
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,496 Total Patients Enrolled
42 Trials studying Prostate Cancer
5,447 Patients Enrolled for Prostate Cancer
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,533 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,296 Patients Enrolled for Prostate Cancer
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,691 Total Patients Enrolled
18 Trials studying Prostate Cancer
4,271 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My scans show cancer has spread to other parts of my body.Your white blood cell count needs to be at least 2,500 K/cumm.My cancer has returned or spread to other parts after initial treatment.I have been treated with cabozantinib before.I completed radiation for bone metastasis over 14 days ago or other radiation over 28 days ago.I have been on hormone therapy for prostate cancer for 12 weeks or less.I have been treated with advanced prostate cancer medications like enzalutamide.I have had radiation therapy for prostate cancer when it was only in the prostate.My scans show cancer has spread to other parts of my body.My bone marrow and organs are functioning normally.I do not have any other cancer that needs treatment right now.My brain metastases have been treated and stable for at least 4 weeks.I have no allergies to cabozantinib, nivolumab, abiraterone, or similar medications.I haven't had major surgery in the last 2 weeks or minor surgery in the last 10 days.My prostate cancer is confirmed to be sensitive to hormones.I do not have any severe illnesses that would make it unsafe for me to join the study.My prostate cancer is aggressive or resistant to hormone therapy.My side effects from previous treatments are mild or back to normal.I haven't taken any kinase inhibitor medication in the last 2 weeks.I have been on steroids or other immune-weakening drugs in the last 2 weeks.I had both testicles removed no more than 12 weeks ago.My testosterone levels are low due to treatment or surgery for cancer.I have received chemotherapy for prostate cancer before.I had both testicles removed no more than 12 weeks ago.Your white blood cell count is high enough without any additional medication to boost it.I cannot swallow pills.I do not have active hepatitis B, C, or HIV.I am not on any strong medications that affect liver enzymes.I have had hormone therapy for prostate cancer when it was only in the prostate.I have or had an autoimmune or inflammatory disorder.I have received an organ transplant from another person.I have previously received immunotherapy treatments.I have previously been treated with medications like abiraterone.You are currently participating in another study that involves testing an experimental drug.I am currently taking blood thinners like warfarin or aspirin.I am 18 years old or older.My prostate cancer is confirmed to be sensitive to hormones.My cancer has spread to other parts of my body, such as bones or organs.I had radiation for bone metastasis over 14 days ago or other radiation over 28 days ago. Radiation for prostate cancer was also done.I am 18 years old or older.I am fully active and can carry on all pre-disease activities without restriction.I may have started hormone therapy for prostate cancer less than 12 weeks ago.My side effects from previous treatments are mild or back to normal.
Research Study Groups:
This trial has the following groups:- Group 1: Level 1: Cabozantinib+Abiraterone acetate +Nivolumab
- Group 2: Level 2: Cabozantinib+Abiraterone acetate +Nivolumab
- Group 3: Expansion: Cabozantinib+Abiraterone acetate +Nivolumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Abiraterone acetate been tested in any other clinical investigations?
"Currently, a total of 1149 clinical studies on Abiraterone acetate are in progress with 187 trials already at Phase 3. Multiple sites across the globe are conducting research for this drug, and 59641 locations have hosted or currently host pivotal investigations on its efficacy. Notably, some of these centres reside within Duarte, California."
Answered by AI
What health conditions is Abiraterone acetate typically employed to address?
"Abiraterone acetate is a common solution for unresectable melanoma and has been explored as a potential treatment for squamous cell carcinoma, ulcerative colitis and cases of high recurrence risk."
Answered by AI
Are there vacancies available for trial participants?
"Affirmative, the details posted to clinicaltrials.gov demonstrate that this medical investigation is recruiting for participants. First published on February 19th 2021 and last edited June 6th 2022, this trial demands 22 patients from a single site."
Answered by AI
How many participants are currently partaking in this research?
"Indeed, the records on clinicaltrials.gov confirm that this research is actively seeking participants. The study was initially listed in February 2021 and edited most recently in June 2022 with a need for 22 patients from one facility."
Answered by AI
What is the regulatory approval status of Abiraterone acetate?
"The perceived safety of abiraterone acetate is estimated to be a 1 on the scale due to this being an early Phase 1 trial, with only minimal evidence supporting its effectiveness and security."
Answered by AI
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