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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 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

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 more

Awards & 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

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05502315 — Phase 2
Cancer Research Study Groups: Experimental Group
Cancer Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT05502315 — Phase 2
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05502315 — Phase 2
~22 spots leftby Apr 2026