Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
On this site
📄 Cabometyx (cabozantinib) drug profile → 📄 Tecentriq (atezolizumab) drug profile → 📄 Xtandi (enzalutamide) drug profile → 📄 Deltasone (prednisone) drug profile →More Exelixis trials in South Korea
Other trials for the same condition
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.
View NCT04446117 on ClinicalTrials.gov ↗ ← All trials in South Korea