Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
- Conditions
- Metastatic Prostate CancerProstate Adenocarcinoma
- Registration Number
- NCT04446117
- Lead Sponsor
- Exelixis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 575
Inclusion Criteria:<br><br> - Men with histologically or cytologically confirmed adenocarcinoma of the prostate<br><br> - Prior treatment with one, and only one, NHT (eg, abiraterone, apalutamide,<br> darolutamide, or enzalutamide) for castration-sensitive locally advanced (T3 or T4)<br> or mCSPC, M0 CRPC, or mCRPC<br><br> - Surgical or medical castration, with serum testosterone = 50 ng/dL (= 1.73 nmol/L)<br> at screening<br><br> - Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment<br> defined by at least one of the following: measurable visceral disease (eg, adrenal,<br> kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic<br> adenopathy (ie, adenopathy above the aortic bifurcation)<br><br> - Progressive disease at study entry as defined by specific criteria for prostate<br> specific antigen (PSA) progression OR soft tissue disease progression in the opinion<br> of the Investigator (Note: subjects with bone disease progression alone are not<br> eligible)<br><br> - Age = 18 years old or meeting country definition of adult, whichever is older, on<br> the day of consent<br><br> - ECOG performance status of 0 or 1<br><br> - Recovery to baseline or = Grade 1 per Common Terminology Criteria for Adverse Events<br> (CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are<br> clinically nonsignificant and/or stable on supportive therapy in the opinion of the<br> Investigator<br><br> - Adequate organ and marrow function based upon specific laboratory assessments<br> obtained within 21 days prior to randomization<br><br> - Understanding and ability to comply with protocol requirements<br><br>Exclusion Criteria:<br><br> - Any prior nonhormonal therapy initiated for the treatment of mCRPC<br><br> - Receipt of abiraterone within 1 week; cyproterone within 10 days; or flutamide,<br> nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within<br> 2 weeks before randomization<br><br> - Radiation therapy within 4 weeks (2 weeks for bone metastases) prior to<br> randomization (subjects with clinically relevant ongoing complications from prior<br> radiation therapy are not eligible)<br><br> - Known brain metastases or cranial epidural disease unless adequately treated and<br> clinically stable at least 4 weeks prior to randomization<br><br> - Symptomatic or impending spinal cord compression or cauda equina syndrome<br><br> - Concomitant anticoagulation with oral anticoagulants (some specific exceptions<br> apply)<br><br> - Administration of a live, attenuated vaccine within 30 days prior to randomization<br><br> - Systematic treatment with, or any condition requiring, either corticosteroids (>10<br> mg daily prednisone equivalent) or other immunosuppressive medications within 14<br> days prior to randomization<br><br> - Uncontrolled, significant intercurrent or recent illness<br><br> - Major surgery within 4 weeks prior to randomization<br><br> - Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per ECG<br> within 21 days before randomization<br><br> - Inability or unwillingness to swallow pills or receive IV administration<br><br> - Previously identified allergy or hypersensitivity to components of the study<br> treatment formulations or history of severe infusion-related reactions to monoclonal<br> antibodies<br><br> - Any other active malignancy at time of randomization or diagnosis of another<br> malignancy within 2 years prior to randomization that requires active treatment<br> (some exceptions apply such as locally curable cancers that have apparently been<br> cured).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of Progression Free Survival per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1);Duration of Overall Survival (OS)
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR)