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Tyrosine Kinase Inhibitor
Cabozantinib + Nivolumab for Advanced Prostate Cancer (CANOPY Trial)
Phase 2
Recruiting
Led By Rana R. McKay, MD
Research Sponsored by Rana McKay, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a drug combo to treat advanced prostate cancer.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join this trial. They must have tried one chemo drug and one hormone-targeting treatment, be willing to use birth control, and have their disease getting worse. HIV-positive men are eligible if treated and stable. People can't join if they've had certain other treatments recently or have specific health issues like severe lung conditions or brain metastases.
What is being tested?
The study is testing a combination of two drugs, Cabozantinib and Nivolumab, in men with metastatic castration-resistant prostate cancer (CRPC). It's an open-label phase 2 trial where all participants receive the same treatment without being compared to a placebo or another drug.
What are the potential side effects?
Cabozantinib may cause diarrhea, mouth sores, hand-foot syndrome (redness and pain on palms/soles), high blood pressure, fatigue. Nivolumab might lead to immune-related side effects such as inflammation in organs like lungs or intestines, skin rash, hormonal gland problems (like thyroid), liver inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Radiographic Progression Free Survival (rPFS)
Secondary study objectives
6-month ORR in predefined subgroups
6-month PSA response in predefined subgroups
6-month rPFS in predefined subgroups
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental GroupExperimental Treatment2 Interventions
40 mg of cabozantinib taken orally every day (days 1-28) of a 28 day cycle
480 mg of nivolumab given intravenously on the first day (day 1) of each 28 day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1760
Nivolumab
2014
Completed Phase 3
~5220
Find a Location
Who is running the clinical trial?
Rana McKay, MDLead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
ExelixisIndustry Sponsor
120 Previous Clinical Trials
20,080 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,471 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that prevents my body from absorbing nutrients properly.My prostate cancer has been confirmed by lab tests.My brain metastases have been treated and stable for at least 4 weeks.I am a man aged 18 or older.I have or am at immediate risk of having spinal cord compression.I have had more than one chemotherapy treatment, not counting first-generation anti-androgens.I do not have active hepatitis B/C or TB requiring treatment.My cancer is of small cell or neuroendocrine type.I have a history of lung scarring or inflammation not caused by infections.I have not had radiation therapy in the week before starting the study treatment.I have had a solid organ or bone marrow transplant.I haven't taken any cancer treatment drugs in the last 4 weeks.I have not received a live vaccine in the last 30 days.I do not have any major health issues that are not under control.I can take care of myself and am up and about more than 50% of my waking hours.I require dialysis.I do not take more than 10 mg of prednisone daily for an autoimmune disease.I have been treated with a taxane and a hormone therapy for my cancer, or I cannot or will not take taxane.I am HIV-positive, on stable treatment, with undetectable viral load and CD4 count over 350.I haven't taken any kinase inhibitor medication in the last 2 weeks.I have previously been treated with cabozantinib or checkpoint inhibitors.My recent tests show my organs are functioning well.I cannot swallow pills.My side effects from previous treatments are mild or back to normal.My prostate cancer is worsening despite low testosterone levels.I am currently taking certain blood thinners not allowed in the study.I haven't taken abiraterone, apalutamide, darolutamide, or enzalutamide in the last 2-4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Group
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.
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