Status:
ACTIVE_NOT_RECRUITING
Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
Lead Sponsor:
Exelixis
Collaborating Sponsors:
Roche-Genentech
Takeda
Conditions:
Metastatic Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 horm...
Detailed Description
The primary objective of this study is to evaluate the efficacy of cabozantinib (XL184) in combination with atezolizumab versus a second NHT (abiraterone or enzalutamide) in subjects with mCRPC who ha...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2026
Estimated Enrollment :
575 Patients enrolled
Trial Details
Trial ID
NCT04446117
Start Date
October 19 2020
End Date
October 16 2026
Last Update
December 18 2025
Active Locations (280)
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1
Exelixis Clinical Site #4
Tucson, Arizona, United States, 85741
2
Exelixis Clinical Site #42
Duarte, California, United States, 91010
3
Exelixis Clinical Site #2
Fullerton, California, United States, 92835
4
Exelixis Clinical Site #224
La Jolla, California, United States, 92093-0698