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

Trial number:
NCT04446117
Trial phase:
3
Study type:
Immunotherapy, Targeted therapy
Overall status:
Recruiting

Study start date

June, 2020

Scientific title

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

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.

Men with histologically or cytologically confirmed adenocarcinoma of the prostatePrior 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

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Intervention model description: Approximately 580 eligible subjects will be randomized in a 1:1 fashion to the experimental arm receiving cabozantinib and atezolizumab in combination (290) or to the control arm receiving a second NHT (290)., Masking: None (Open Label),

Conditions

Metastatic Prostate Cancer, Prostate Adenocarcinoma

Other study ID numbers

XL184-315

Choose trial site (300)