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)
Duration of Progression Free Survival (PFS) Per Response Evaluable Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Radiology Committee (BIRC) — Up to a maximum of approximately 30 months (Median duration of follow-up was 14.31 months) Duration of PFS was defined as the time from randomization to the earlier of either the date of radiographic progression (defined as progressive disease \[PD\] per RECIST 1.1) per BIRC or the date of death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions, with an absolute increase of ≥ 5 mm, unequivocal progression of non-target lesions and/or the appearance of new lesions.
Duration of Overall Survival (OS) — Up to a maximum of approximately 45 months (Median duration of follow-up was 24.05 months) Duration of OS was defined as the time from randomization to death due to any cause. For participants, who were not known to have died at the time of data cutoff and were permanently lost to follow-up, duration of OS was censored at the earlier of the following dates: date the participant was last known to be alive or date of full withdrawal of consent (including survival follow-up), or date of data cutoff.
OS was calculated as earlier of date of death or censoring - date of randomization + 1)/30.4375
Trial sites (280)
Facility
City
Region
Status
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.
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.