NCT03551782|CompletedPhase 1FDA Drug

A Study of Cetrelimab (JNJ-63723283), a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, Administered in Combination With Apalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer

An Open-label, Multicenter, Phase 1b Study of JNJ-63723283, a PD-1 Inhibitor, Administered in Combination With Apalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer

Janssen Research & Development, LLC ClinicalTrials.gov

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3 other identifiers

CR1084762018-000182-3756021927PCR2032

Study Type

interventional

Target

Locations

7 countries

Sites

Timeline

RegisteredJun 2018

StartedJun 2018

CompletionNov 2021

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Jun 2018

Typical duration for phase_1

Geographic Reach

7 countries

34 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.4 years study duration

First Submitted

Initial submission to the registry

May 30, 2018

Completed

12 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed

17 days until next milestone

Study Start

First participant enrolled

June 28, 2018

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2021

Completed

Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

3.4 years

First QC Date

May 30, 2018

Last Update Submit

February 24, 2022

Conditions

Castration-Resistant Prostatic Neoplasms

Outcome Measures

Primary Outcomes (3)

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.
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.
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.
Week 12

Secondary Outcomes (2)

Maximal PSA Decline
Approximately 2 years
Percentage of Participants with Circulating Tumor Cell (CTC) Response
Approximately 2 years

Study Arms (5)

Cohort 1

EXPERIMENTAL

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).