Cabozantinib + Atezolizumab for Prostate Cancer

(CONTACT-02 Trial)

Recruiting at312 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Exelixis

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Men with advanced prostate cancer that has resisted castration and have already tried one hormonal therapy can join. They must be adults with good organ function, able to follow the study plan, and not have other active cancers or severe illnesses. Men who've had major surgery recently or those on certain medications are excluded.

Inclusion Criteria

Understanding and ability to comply with protocol requirements

I have cancer that has spread outside my pelvis and can be measured.

I am fully active or can carry out light work.

Exclusion Criteria

Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per ECG within 21 days before randomization

I haven't taken any prostate cancer hormone treatments recently.

I haven't taken high-dose steroids or immunosuppressants in the last 14 days.

Treatment Details

Interventions

• Atezolizumab (Checkpoint Inhibitor)
• Cabozantinib (Tyrosine Kinase Inhibitor)

Trial Overview The trial is testing Cabozantinib combined with Atezolizumab against a second novel hormonal therapy (NHT) in men whose prostate cancer has spread despite castration. It's a Phase 3 study where participants are randomly assigned to either treatment group.

Participant Groups

Group I: Experimental Arm Experimental Treatment 2 Interventions

Subjects with mCRPC will receive cabozantinib 40mg oral, qd + atezolizumab 1200mg infusion, q3w

Group II: Control Arm Active Control 3 Interventions

Subjects with mCRPC will receive active comparator of EITHER abiraterone 1000mg oral, qd + prednisone 5 mg oral, bid; OR enzalutamide 160mg oral, qd as designated by the Investigator prior to randomization

Who Is Running the Clinical Trial?

Exelixis

Lead Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Takeda

Industry Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Roche-Genentech

Industry Sponsor

Trials

27

Recruited

3,800+