A Phase 1 interventional study of Cetrelimab 480 mg and Apalutamide 240 mg in Castration-Resistant Prostatic Neoplasms, sponsored by Janssen Research & Development, LLC. Completed at 34 sites in 7 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-25.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety of the combination of cetrelimab, with apalutamide and to define a population of participants with metastatic castration-resistant prostate cancer (mCRPC) who respond to treatment with the combination of cetrelimab and apalutamide.
This study is of participants originally diagnosed with adenocarcinoma of the prostate who have now developed mCRPC and who have progressed on therapy with abiraterone acetate plus prednisone/prednisolone (AA-P), apalutamide, darolutamide, or enzalutamide. Participants with treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) assessed by the screening biopsy may be considered for this study. Participants must have confirmed prostate-specific antigen (PSA) progression per Prostate Cancer Clinical Trials Working Group (PCWG3) criteria. The primary hypothesis is that treatment with cetrelimab and apalutamide is safe and leads to improvement in the 12-week PSA response rate. The study consists of an Optional Pre-screening Period, Screening period (28 days prior to Cycle 1 Day 1), Treatment Period, End-of-Treatment Visit (performed after the last dose of study drug is administered), and Follow-up Period (participants will have Follow-up assessment every 12 weeks after the End-of-Treatment Visit). The efficacy, safety, and pharmacokinetics of cetrelimab in combination with apalutamide will be evaluated.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 33 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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Exclusion Criteria:
Biomarker-negative or biomarker-unknown participants with adenocarcinoma (and not treatment-emergent small-cell neuroendocrine prostate cancer \[t-SCNC\]) who progressed on abiraterone acetate plus prednisone/prednisolone (AA-P) will be enrolled in this cohort. Participants will receive cetrelimab 480 milligram (mg) plus apalutamide 240 mg daily starting Cycle 1 (each cycle of 28 days).
Drug: Cetrelimab 480 mg · Drug: Apalutamide 240 mg
Biomarker-negative or biomarker-unknown participants with adenocarcinoma (and not t-SCNC) who progressed on apalutamide, darolutamide, or enzalutamide will be enrolled in this cohort. Participants will receive cetrelimab 480 mg plus apalutamide 240 mg daily starting Cycle 1.
Drug: Cetrelimab 480 mg · Drug: Apalutamide 240 mg
Biomarker-positive participants who progressed on AA-P will be enrolled in this cohort. Participants will receive cetrelimab 480 mg plus apalutamide 240 mg daily starting Cycle 1 (each cycle of 28 days).
Drug: Cetrelimab 480 mg · Drug: Apalutamide 240 mg
Biomarker-positive participants who progressed on apalutamide, darolutamide, or enzalutamide will be enrolled in this cohort. Participants will receive cetrelimab 480 mg plus apalutamide 240 mg daily starting Cycle 1 (each cycle of 28 days).
Drug: Cetrelimab 480 mg · Drug: Apalutamide 240 mg
Biomarker-negative participants with t-SCNC who progressed on treatment with AA-P, apalutamide, darolutamide, or enzalutamide will be enrolled in this cohort. Participants will receive cetrelimab 480 mg plus apalutamide 240 mg daily starting Cycle 1 (each cycle of 28 days).
Drug: Cetrelimab 480 mg · Drug: Apalutamide 240 mg
Cetrelimab 480 mg will be administered intravenously (IV) on Cycle 1 Day 1, then every 4 weeks thereafter (Q4W).
Also known as: JNJ-63723283
Apalutamide 240 mg (4\*60 mg) tablets per day will be administered orally.
Also known as: JNJ-56021927
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Approximately 2 years
Number of Participants with AEs by Severity
Severity of AEs will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Any AE not listed in the NCI CTCAE will be graded according to the investigator clinical judgment by using the standard grades as follows: Grade 1 Mild: Awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 Moderate: Sufficient discomfort is present to cause interference with normal activity; Grade 3 Severe: Extreme distress, causing significant impairment of functioning or incapacitation. Prevents normal everyday activities; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to the AE.
Time frame: Approximately 2 years
Percentage of Participants with Prostate-Specific Antigen (PSA) Response at Week 12
Percentage of participants with baseline in PSA level response (greater than or equal to \[\>=\]50 percent \[%\] decrease from baseline in PSA) will be reported at Week 12.
Time frame: Week 12
Maximal PSA Decline
Maximal PSA decline is defined as maximal percent decrease in PSA at any time during treatment.
Time frame: Approximately 2 years
Percentage of Participants with Circulating Tumor Cell (CTC) Response
Percentage of participants with CTC response (either CTC less than \[\<\]5 cells/7.5 milliliter \[mL\] with CTC \>=5 at baseline or CTC = 0 cells/7.5 mL with CTC \>=1 at baseline) will be reported.
Time frame: Approximately 2 years
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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