Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
Trial ID or NCT#
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.
A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer
- - 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
- - 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).
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Noel Jaclyn Del Toro