Combination treatment for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and optimal dosing regimen of two investigational drugs, JNJ-87189401 and JNJ-78278343, in patients with advanced prostate cancer. The trial consists of two parts: the first part focuses on dose escalation to determine the recommended phase 2 regimen, while the second part involves dose expansion to further assess safety. Participants must have metastatic castration-resistant prostate cancer and meet specific eligibility criteria, including prior androgen deprivation therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
* Measurable or evaluable disease per PCWG3 criteria
* Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* History of an autoimmune disease within the 12 months prior to signing consent
* Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association \[NYHA\] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident

Where it's running

• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• Emory University Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• University Of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• START New Jersey
  East Brunswick, New Jersey, United States Recruiting
• Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
  New York, New York, United States Recruiting
• Montefiore Medical Center
  The Bronx, New York, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.