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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
Histological or cytological proof of prostate adenocarcinoma.
Males 18 years of age and above.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

CANOPY Trial 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.Check my eligibility
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.See study design
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.

CANOPY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer has been confirmed by lab tests.
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I am a man aged 18 or older.
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I can take care of myself and am up and about more than 50% of my waking hours.

CANOPY Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiographic Progression Free Survival (rPFS)
Secondary outcome measures
6-month ORR in predefined subgroups
6-month PSA response in predefined subgroups
6-month rPFS in predefined subgroups
+9 more

CANOPY 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
~1080
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

ExelixisIndustry Sponsor
116 Previous Clinical Trials
18,037 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,296 Patients Enrolled for Prostate Cancer
Bristol-Myers SquibbIndustry Sponsor
2,631 Previous Clinical Trials
4,126,618 Total Patients Enrolled
42 Trials studying Prostate Cancer
5,447 Patients Enrolled for Prostate Cancer
Rana McKay, MDLead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Prostate Cancer
32 Patients Enrolled for Prostate Cancer

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05502315 — Phase 2
Prostate Cancer Research Study Groups: Experimental Group
Prostate 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards may be associated with participation in the Experimental Group?

"Our team at Power assigns a score of 2 to Experimental Group, due to its Phase 2 status. This signifies that clinical data exists regarding the treatment's safety but none yet related to efficacy."

Answered by AI

How many participants are currently contributing to this medical experiment?

"Affirmative. According to the information published on clinicaltrials.gov, this medical research is actively recruiting participants since it was posted on February 2nd 2023 and recently updated with the same date. 50 volunteers need to be recruited from a single centre."

Answered by AI

Is there currently an opportunity for individuals to partake in this medical investigation?

"Affirmative. Clinicaltrials.gov provides evidence of this medical trial's active recruitment, beginning on February 2nd 2023 and updated at the same time. The research is enrolling 50 participants from a single site."

Answered by AI
~3 spots leftby May 2024