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ACTIVE NOT RECRUITING Phase 3

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

NCT04446117 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Atezolizumab
  • DRUG Prednisone
  • DRUG Cabozantinib
  • DRUG Enzalutamide
  • DRUG Abiraterone Acetate

Study Locations (20)

California

  • Exelixis Clinical Site #42 — Duarte
  • Exelixis Clinical Site #2 — Fullerton
  • Exelixis Clinical Site #224 — La Jolla
  • Exelixis Clinical Site #3 — Marina del Rey
  • Exelixis Clinical Site #114 — San Diego
  • Exelixis Clinical Site #125 — Santa Monica
  • Exelixis Clinical Site #245 — Stanford

Colorado

  • Exelixis Clinical Site #91 — Aurora
  • Exelixis Clinical Site #14 — Denver

Connecticut

  • Yale University School of Medicine — New Haven
  • Yale University, School of Medicine — New Haven

Arizona

  • Exelixis Clinical Site #4 — Tucson

Florida

  • Exelixis Clinical Site #108 — Miami

Georgia

  • Winship Cancer Institute of Emory University — Atlanta

Kansas

  • Exelixis Clinical Site #215 — Westwood

Kentucky

  • Exelixis Clinical Site #242 — Louisville

Trial Details

FieldValue
Enrollment Target 575 participants
Start Date 2020-10-19
Est. Completion 2026-10-16
Phase Phase 3

Sponsor

Exelixis

54 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04446117

The ClinicalTrials.gov registry entry for NCT04446117 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 575 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Exelixis, which has 54 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions — of which Atezolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04446117 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Colorado, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04446117 about?

NCT04446117 is a clinical study titled "Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC". 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 prev...

What is the current status of trial NCT04446117?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 575 participants. The study started on 2020-10-19. Estimated completion is 2026-10-16.

What conditions does trial NCT04446117 study?

This clinical trial studies the following conditions: Prostate Adenocarcinoma, Metastatic Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04446117?

The interventions under investigation include: Atezolizumab (DRUG), Prednisone (DRUG), Cabozantinib (DRUG), Enzalutamide (DRUG), Abiraterone Acetate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04446117?

This trial is sponsored by Exelixis, which has 54 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04446117 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial