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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two drugs, apalutamide (Erleada) and cetrelimab (an experimental treatment), to determine if they work better together than alone in treating a specific type of prostate cancer. The focus is on patients with prostate cancer that has spread and become resistant to standard treatments, particularly those with small cell neuroendocrine features. The goal is to assess whether this drug combination can control the cancer more effectively. Suitable candidates for this trial include those whose prostate cancer has become resistant to hormone therapy and exhibits small cell neuroendocrine features. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you must not take any other systemic anti-cancer therapies besides LHRH analogue within 14 days before starting the study treatment. If you are already taking apalutamide, you can continue it without a break.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of apalutamide and cetrelimab is under evaluation for safety in people. In studies, apalutamide demonstrated promising results, achieving a 100% success rate in preventing cancer recurrence within 24 months for patients who underwent surgery for high-risk prostate cancer. This indicates it is well-tolerated in certain situations.

For cetrelimab, ongoing research is assessing its safety when used with apalutamide. Although specific side effect information is not yet available, the combination is actively studied to ensure safety. Since this trial is in Phase 2, the treatment has already undergone basic safety testing in earlier trials, but more data is needed to fully understand its safety in larger populations. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Apalutamide and Cetrelimab for prostate cancer because it introduces a novel approach to treatment. Unlike traditional therapies that primarily focus on androgen deprivation, Apalutamide is an androgen receptor inhibitor that directly targets and blocks the action of male hormones driving the cancer. Cetrelimab, on the other hand, is an immune checkpoint inhibitor, aiming to enhance the body's own immune response against cancer cells. This dual action not only targets cancer cells more comprehensively but also has the potential to improve outcomes by reducing tumor growth and boosting immune attack, offering hope for more effective management of prostate cancer.

What evidence suggests that the combination of Apalutamide and Cetrelimab could be effective for prostate cancer?

Research has shown that using apalutamide and cetrelimab together holds promise for improving prostate cancer treatment. In this trial, participants will receive a combination of apalutamide and cetrelimab. Apalutamide has been shown to lower the risk of death by 23% over two years in patients with hormone-responsive prostate cancer. It also extends survival when combined with standard hormone treatments. When cetrelimab is used with apalutamide, it improves PSA (prostate-specific antigen) levels, suggesting it may help control cancer growth. This combination targets both the hormones that fuel cancer and the immune system, enhancing the fight against cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Rahul Aggarwal, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03551782

NCT03551782 | A Study of Cetrelimab (JNJ-63723283), a ... The primary hypothesis is that treatment with cetrelimab and apalutamide is safe and leads to improvement in the 12-week PSA response rate.

2. jnj.com jnj.com/media-center/press-releases/erleada-apalutamide-demonstrates-statistically-significant-and-clinically-meaningful-improvement-in-overall-survival-compared-to-enzalutamide-in-patients-with-metastatic-castration-sensitive-prostate-cancer

ERLEADA® (apalutamide) demonstrates statistically ... Largest head-to-head real-world study in mCSPC demonstrated that ERLEADA® reduced risk of death by 23 percent at 24 months compared to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03551782

A Study of Cetrelimab (JNJ-63723283), a Programmed ... The primary hypothesis is that treatment with cetrelimab and apalutamide is safe and leads to improvement in the 12-week PSA response rate.

4. erleadahcp.com erleadahcp.com/efficacy/

Efficacy | ERLEADA® (apalutamide) HCP The survival rate at 48 months was 65.1% for ERLEADA ® + ADT patients vs 51.8% for placebo + ADT patients. ... OS improved regardless of Gleason score, age, high- ...

5. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT03551782/

Clinical Trial: NCT03551782 The primary hypothesis is that treatment with cetrelimab and apalutamide is safe and leads to improvement in the 12-week PSA response rate.

6. jnj.com jnj.com/media-center/press-releases/phase-2-data-for-erleada-apalutamide-plus-androgen-deprivation-therapy-following-radical-prostatectomy-in-patients-with-high-risk-localized-prostate-cancer-show-100-biochemical-free-recurrence-rate-more-than-two-years-post-surgery

Phase 2 data for ERLEADA® (apalutamide) plus androgen ... Following RP, patients who received the treatment regimen showed a 100% biochemical recurrence (BCR)–free rate at 24 months.

7. jnj.com jnj.com/media-center/press-releases/johnson-johnson-highlights-ambition-to-transform-the-treatment-of-prostate-cancer-and-bladder-cancer-through-data-presentations-at-asco-gu

Clinical and real-world evidence data support treatment ... Key presentations will include new real-world evidence data adding to the strong and differentiated clinical profile of ERLEADA® (apalutamide) ...

8. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/398979

A Study of JNJ-78278343 in Combination With Either ... The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation)