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Clinical Trials in the UK / NCT04446117
Active, not recruiting Phase 3

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

NCT04446117 · tracked via the Priya Life Science UK tracker
Sponsor
Exelixis
Phase
Phase 3
Started
2020-10-19
Last updated
2025-12-18

Condition(s) studied

Metastatic Prostate CancerProstate Adenocarcinoma

Investigational drug(s) / intervention(s)

CabozantinibAtezolizumabAbiraterone AcetateEnzalutamidePrednisone

Cabozantinib: Supplied as 20-mg tablets; administered orally daily at 40mg

Atezolizumab: Supplied as 1200 mg/20 mL vials; administered as an IV infusion once every 3 weeks (q3w)

Abiraterone Acetate: Supplied as 500 mg tablets; administered orally daily at 1000mg with prednisone 5 mg orally bid

Enzalutamide: Supplied as 40 mg capsules; administered orally daily at 160mg

Prednisone: Supplied as 5 mg tablets; administered orally bid at 5 mg with abiraterone 1000mg orally daily

Study summary

This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Men with histologically or cytologically confirmed adenocarcinoma of the prostate * Prior treatment with one, and only one, NHT (eg, abiraterone, apalutamide, darolutamide, or enzalutamide) for castration-sensitive locally advanced (T3 or T4) or mCSPC, M0 CRPC, or mCRPC * Surgical or medical castration, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening * Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment defined by at least one of the following: measurable visceral disease (eg, adrenal, kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic adenopathy (ie, adenopathy above the aortic bifurcation) * Progressive disease at study entry as defined by specific criteria for prostate specific antigen (PSA) progression OR soft tissue disease progression in the opinion of the Investigator (Note: subjects with bone disease progression alone are not eligible) * Age ≥ 18 years old or meeting country definition of adult, whichever is older, on the day of consent * ECOG performance status of 0 or 1 * Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator * Adequate organ and marrow function based upon specific laboratory assessments obtained within 21 days prior to randomization * Understanding and ability to comply with protocol requirements Exclusion Criteria: * Any prior nonhormonal therapy initiated for the treatment of mCRPC * Receipt of abiraterone within 1 week; cyproterone within 10 days; or flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within 2 weeks before randomization * Radiation therapy within 4 weeks (2 weeks for bone metastases) prior to randomization (subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible) * Known brain metastases or cranial epidural disease unless adequately treated and clinically stable at least 4 weeks prior to randomization * Symptomatic or impending spinal cord compression or cauda equina syndrome * Concomitant anticoagulation with oral anticoagulants (some specific exceptions apply) * Administration of a live, attenuated vaccine within 30 days prior to randomization * Systematic treatment with, or any condition requiring, either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization * Uncontrolled, significant intercurrent or recent illness * Major surgery within 4 weeks prior to randomization * Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms per ECG within 21 days before randomization * Inability or unwillingness to swallow pills or receive IV administration * Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies * Any other active malignancy at time of randomization or diagnosis of another malignancy within 2 years prior to randomization that requires active treatment (some exceptions apply such as locally curable cancers that have apparently been cured).

Primary outcome measure(s)

Trial sites (280)

FacilityCityRegionStatus
Exelixis Clinical Site #4 Tucson Arizona
Exelixis Clinical Site #42 Duarte California
Exelixis Clinical Site #2 Fullerton California
Exelixis Clinical Site #224 La Jolla California
Exelixis Clinical Site #3 Marina del Rey California
Exelixis Clinical Site #114 San Diego California
Exelixis Clinical Site #125 Santa Monica California
Exelixis Clinical Site #245 Stanford California
Exelixis Clinical Site #91 Aurora Colorado
Exelixis Clinical Site #14 Denver Colorado
Yale University School of Medicine New Haven Connecticut
Yale University, School of Medicine New Haven Connecticut
Exelixis Clinical Site #108 Miami Florida
Winship Cancer Institute of Emory University Atlanta Georgia
Exelixis Clinical Site #215 Westwood Kansas
Exelixis Clinical Site #242 Louisville Kentucky
Exelixis Clinical Site #6 Baltimore Maryland
Non-participating Site Detroit Michigan
Exelixis Clinical Site #203 Rochester Minnesota
Exelixis Clinical Site #19 Omaha Nebraska
Exelixis Clinical Site #144 Las Vegas Nevada
Exelixis Clinical Site #123 East Brunswick New Jersey
Non-participating Site Lawrenceville New Jersey
Weill Cornell Medical College New York New York
Exelixis Clinical Site #198 The Bronx New York
Exelixis Site #159 Cleveland Ohio
Exelixis Clinical Site #221 Oklahoma City Oklahoma
Exelixis Clinical Site #18 Philadelphia Pennsylvania
Exelixis Clinical Site #201 Pittsburgh Pennsylvania
Exelixis Clinical Site #1 Nashville Tennessee
Exelixis Clinical Site #5 Houston Texas
Exelixis Clinical Site #177 Houston Texas
Exelixis Clinical Site #259 Houston Texas
Exelixis Clinical Site #41 Temple Texas
Exelixis Clinical Site #67 Salt Lake City Utah
Exelixis Clinical Site #143 Roanoke Virginia
Exelixis Clinical Site #122 Ciudad Autonoma de Buenos Aire Buenos Aires
Exelixis Clinical Site #120 Mar del Plata Buenos Aires
Exelixis Site #170 Pergamino Buenos Aires
Exelixis Clinical Site #210 Córdoba Córdoba Province

+ 240 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04446117 on ClinicalTrials.gov ↗ ← All trials in the UK