Apalutamide + Cetrelimab for Prostate Cancer

Overseen By UCSF Genitourinary Medical Oncology Recruitment

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Rahul Aggarwal

Must be taking: Apalutamide

Must not be taking: Immune checkpoint inhibitors

Disqualifiers: Autoimmune disease, Cardiac condition, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

2 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a combination of two drugs, apalutamide and cetrelimab, in patients with a hard-to-treat form of prostate cancer. Apalutamide blocks male hormones that help cancer grow, and cetrelimab boosts the immune system to fight the cancer. The goal is to see if this combination can effectively treat patients who haven't responded to other treatments.

Research Team

Rahul Aggarwal, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for men aged 18+ with prostate cancer that has become resistant to hormone therapy and shows small cell neuroendocrine features. They must have had no more than one prior chemo in the metastatic setting, be able to perform daily activities (ECOG <=1), and agree to use contraception. Excluded are those with certain immune conditions, recent vaccines or other treatments, infections needing IV antibiotics, gastrointestinal absorption issues, or a history of seizures.

Inclusion Criteria

I haven't had cancer treatments except for LHRH analogues in the last 14 days or 5 half-lives, and my side effects from previous treatments are minimal.

My PSA level is over 2 ng/mL or my cancer can be measured by scans.

I have had only one taxane-based chemotherapy for advanced prostate cancer.

Exclusion Criteria

I had radiotherapy less than 2 weeks before starting the trial.

I am HIV positive without effective treatment and have had an undetectable viral load for 6 months.

I do not have another cancer that needs treatment during this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Apalutamide tablets combined with infusions of Cetrelimab in 28-day cycles

Up to 24 months

Follow-up

Participants are monitored for safety evaluations 30 days and 100 days after treatment completion and for overall survival every 90 days

Variable, until death, withdrawal of consent, or end of study

Treatment Details

Interventions

• Apalutamide
• Cetrelimab

Trial Overview The study tests if adding apalutamide (a drug blocking male hormones) to cetrelimab (an immunotherapy drug) can help patients whose prostate cancer has changed into a form not driven by male hormones. Participants will receive both drugs and their response will be monitored through clinical assessments.

Participant Groups

Group I: Single Arm: Apalutamide + Cetrelimab Experimental Treatment 2 Interventions

Participants will be given Apalutamide tablets combined with infusions of Cetrelimab in 28-day cycles, for up maximum of two years.

Apalutamide is already approved in United States, European Union for the following indications:

Approved in United States as Erleada for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic castration-sensitive prostate cancer (mCSPC)

Approved in European Union as Erleada for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic castration-sensitive prostate cancer (mCSPC)

Who Is Running the Clinical Trial?

Rahul Aggarwal

Lead Sponsor

Trials

13

Recruited

550+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD