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Castration-resistant Prostate CancerPhase 2CANOPYNCT05502315

Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer

A Phase 2 study testing Cabozantinib and Nivolumab in people with Castration-resistant Prostate Cancer and Metastatic Cancer, run by Rana McKay, MD at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multicenter, single-arm, two-stage open-label phase 2 study of the combination of cabozantinib + nivolumab in subjects with advanced castration-resistant prostate cancer (CRPC). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Cabozantinib and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
4 sitesUnited States
Study dates
2 Feb 2023to 12 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following applicable inclusion criteria to participate in this study:
  • Willing and able to provide, or have a legally authorized representative provide, written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
  • Males 18 years of age and above.
  • Histological or cytological proof of prostate adenocarcinoma or mixed adenocarcinoma/neuroendocrine tumors. Pure small cell of the prostate is not allowed.
  • ECOG status of ≤ 2
  • Progressive mCRPC as defined: 1) castrate levels of serum testosterone < 50 ng/dL AND 2) progressive disease as defined by PSA or radiographic progression. Subjects with measurable and non-measurable disease (i.e., bone only metastases) are allowed. NOTE: ENROLLMENT of subjects with non-measurable disease (i.e., bone only metastases) will be capped at 50% of enrollment target (n=25).
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  • Must have exposure to one prior taxane (or be taxane ineligible or refuse taxane) AND one prior AR-targeting agent (for example, abiraterone, enzalutamide, apalutamide, darolutamide). Receipt of taxane or AR-targeting agent may be in the hormone sensitive or castration resistant setting. Subjects may have received more than 1 prior Androgen receptor signaling inhibitors (ARSI). Subjects may have had prior 177Lu-PSMA-617.
  • Recovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
  • Normal organ function with acceptable initial laboratory values within 14 days of treatment start:
  • WBC: ≥ 2,500/mcL
  • ANC: ≥ 1,500/mcL
  • Hemoglobin: ≥ 9 g/dL (transfusions are permitted)
  • Platelet count: ≥ 100,000/mcL
  • Serum creatinine or calculated Creatinine Clearance: Serum creatinine ≤ 1.5 x ULN or calculated CrCl ≥ 30 mL/min as defined by Cockcroft-Gault equation
  • Total Bilirubin: ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert's disease)
  • SGOT (AST): ≤ 3 x ULN
  • SGPT (ALT): ≤ 3 x ULN
  • Alkaline Phosphatase (ALP): ≤ 5 x ULN with documented bone metastases
  • Serum Albumin: ≥ 2.8 g/dL
  • Urine protein/creatinine ratio (UPCR): ≤ 2 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 2 g
  • Subjects must agree to use a medically acceptable method of birth control as outlined in the protocol
  • HIV-positive with negative viral loads on stable antiretroviral regimen will be considered eligible. Subjects must have CD4 count > 350.

Who cannot join

  • Subjects meeting any of the criteria below may not participate in the study:
  • Disease progression on prior checkpoint inhibitor treatment.
  • Prior cabozantinib.
  • Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
  • Receipt of any type of cytotoxic, biologic or investigational systemic anti-cancer agent within 4 weeks before first dose of study treatment.
  • Treatment with abiraterone, apalutamide, or darolutamide within 2 weeks of treatment initiation. Treatment with investigational prostate cancer directed therapy within 4 weeks of treatment initiation. Treatment with enzalutamide within 4 weeks of treatment initiation.
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  • Receipt of more than 1 line of chemotherapy (including both hormone sensitive and CRPC). First-generation anti-androgen use (such as bicalutamide) will not be tabulated as a line of therapy.
  • Administration of a live, attenuated vaccine within 30 days prior to first dose of study treatment.
  • Active autoimmune disease or condition requiring prednisone >10 mg daily (or equivalent). Physiologic replacement is permitted. Topical, ocular, intra-articular steroids or inhaled corticosteroids are permitted.
  • Imminent or established spinal cord compression based on clinical and/or imaging findings.
  • Radiation therapy within 1 week of study treatment start.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
  • Malabsorption syndrome.
  • Requirement for hemodialysis or peritoneal dialysis.
  • History of solid organ or allogenic stem cell transplant.
  • Active hepatitis B/C or positive TB test with active mycobacterial infection requiring systemic treatment.
  • Active treatment (within 5 days of registration) with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:
  • Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose molecular weight heparins (LMWH).
  • Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
  • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
  • Cardiovascular disorders:
  • Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.
  • Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment.
  • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose of study treatment.
  • Subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion above) for at least 1 week before first dose of study treatment.
  • Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation
  • The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.
  • Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.
  • Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.
  • Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.
  • Lesions invading or encasing any major blood vessels.
  • Other clinically significant disorders that would preclude safe study participation.
  • Serious non-healing wound/ulcer/bone fracture.
  • Uncompensated/symptomatic hypothyroidism.
  • Moderate to severe hepatic impairment (Child-Pugh B or C).
  • Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
  • Corrected QT interval calculated by Fridericia formula (QTcF) >500 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment [add reference for Fridericia formula]. NOTE: If a single ECG shows a QTcF with an absolute >500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility.
  • Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer or superficial bladder cancer.
  • Known allergy to any of the compounds under investigation.
  • Inability to swallow tablets.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • University of California San Diego

    La Jolla, California, 92093

  • University of Wisconsin

    Madison, Wisconsin, 53705

Other trials in United States

About this study

Official title: A Phase 2 Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer

This is a multicenter, single-arm, two-stage open-label phase 2 study of the combination of cabozantinib + nivolumab in subjects with advanced castration-resistant prostate cancer (CRPC).

Read the detailed description

Eligible subjects will undergo a baseline biopsy prior to treatment initiation. They will then initiate treatment with cabozantinib (40 mg orally daily) and nivolumab (480 mg intravenously every four weeks). An on-treatment biopsy will be performed during Cycle 2. Subjects will continue treatment until radiographic progression, toxicity or withdrawal. Prostate-specific antigen (PSA) levels will be evaluated once every cycle. Radiographic assessments will occur every two cycles for one year and then every three cycles thereafter. Cycle length is 28 days.

Being tested
Cabozantinib, Nivolumab
Keywords
Castration resistant prostate cancer, Immunotherapy, Targeted therapy, Bone metastases
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05502315
Study groupRoleWhat they receive
Experimental GroupExperimental40 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
Receives: Drug: Cabozantinib; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic Progression Free Survival (rPFS)

    The primary endpoint is the efficacy of treatment via assessment of 6 month rPFS defined by RECIST version 1.1 for soft tissue and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases. rPFS is defined as the duration of time from the first day of the start of study treatment to time of radiographic progression or death due to any cause, whichever occurs first.

    Measured: 6 months

Secondary outcomes (12)

  1. PSA Response

    PSA response per PCWG3. PSA response defined as a ≥50% decline in PSA from baseline (measured twice at least 3 weeks apart).

    Measured: 3 years

  2. Overall Response Rate (ORR)

    ORR by RECIST version 1.1 in subjects with measurable disease. ORR will be defined using RECIST version 1.1 criteria for subjects with measurable disease.

    Measured: 3 years

  3. 6-month rPFS in predefined subgroups

    Defined as 1) subjects with and without visceral metastases and 2) subjects with and without bone metastases. 6 month rPFS defined by RECIST version 1.1 for soft tissue and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases. rPFS is defined as the duration of time from the first day of the start of study treatment to time of radiographic progression or death due to any cause, whichever occurs first.

    Measured: 6 months

  4. 6-month PSA response in predefined subgroups

    Defined as 1) subjects with and without visceral metastases and 2) subjects with and without bone metastases. PSA response per PCWG3. PSA response defined as a ≥50% decline in PSA from baseline (measured twice at least 3 weeks apart).

    Measured: 6 months

  5. 6-month ORR in predefined subgroups

    Defined as 1) subjects with and without visceral metastases and 2) subjects with and without bone metastases. ORR by RECIST version 1.1 in subjects with measurable disease.

    Measured: 6 months

  6. rPFS

    Defined by radiographic progression by RECIST 1.1 for soft tissue and PCWG3 version 1.1 for bone metastases.

    Measured: 3 years

  7. Overall Survival (OS)

    Overall survival (OS) is defined as time from start of study treatment to the date of death from any cause. Subjects who are alive will be censored at last follow up date.

    Measured: 3 years

  8. Assess conversion of circulating tumor cell (CTC) count

    Conversion of CTC count from ≥ 5 cells/7.5 mL blood at baseline to < 5 cells/7.5 mL blood confirmed by at least two readings 4 weeks apart.

    Measured: 3 years

  9. Assess adverse events

    Safety and tolerability as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: 3 months

  10. Time to PSA Progression

    Time to PSA progression as defined by PCWG3 criteria.

    Measured: 3 years

  11. Time to occurrence of first symptomatic skeletal event.

    A skeletal related event is the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumor related orthopedic surgical intervention.

    Measured: 3 years

  12. Time from treatment discontinuation to first subsequent anti-cancer therapy

    Evaluate time from treatment discontinuation to first subsequent anti-cancer therapy (including androgen receptor signaling agents, cytotoxic chemotherapy, immunotherapy, or investigational agents) or death.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2022
  2. Study start2 Feb 2023
  3. Primary completion12 Nov 2026 (estimated)
  4. Study completion12 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05502315
Sponsor's protocol ID
HCRN GU21-517
Acronym
CANOPY
Status last verified
Oct 2026
First submitted
18 Jul 2022
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabozantinib and Nivolumab in people with Castration-resistant Prostate Cancer and Metastatic Cancer, run by Rana McKay, MD at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression Free Survival (rPFS) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05502315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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