Trial Outcomes & Findings for Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer (NCT NCT04926181)

Results Overview

The composite response rate is determined by a combination of a decline from baseline in serum PSA of \>= 50%, confirmed by repeat measurement ≥ 4 weeks later (PSA50) AND a complete response (CR) or partial response (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria confirmed by repeat scan ≥ 4 weeks later.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2025-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm: Apalutamide + Cetrelimab Participants will be given Apalutamide tablets combined with infusions of Cetrelimab in 28-day cycles, for up maximum of two years.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm: Apalutamide + Cetrelimab n=2 Participants Participants will be given Apalutamide tablets combined with infusions of Cetrelimab in 28-day cycles, for up maximum of two years.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: Confirmatory data required to determine response was not collected.

The composite response rate is determined by a combination of a decline from baseline in serum PSA of \>= 50%, confirmed by repeat measurement ≥ 4 weeks later (PSA50) AND a complete response (CR) or partial response (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria confirmed by repeat scan ≥ 4 weeks later.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Proportion of participants with an adverse event determined to be related to study treatment, and classified using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0)

Outcome measures

Outcome measures
Measure	Single Arm: Apalutamide + Cetrelimab n=2 Participants Participants will be given Apalutamide tablets combined with infusions of Cetrelimab in 28-day cycles, for up maximum of two years.
Proportion of Participants With Treatment-related Adverse Events (AEs)	1.00 proportion of participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Confirmatory data required to determine response was not collected.

PFS is defined as the time from initiation of study treatment until radiographic progression by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death, whichever occurs first. Response required to determine median PFS must be confirmed by repeat measurement ≥ 4 weeks later.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Defined as the proportion of participants with a demonstrated \>= 50% decline from baseline serum PSA confirmed by repeat measurement \>= 4 weeks after first time point at any time during the course of the study.

Outcome measures

Outcome measures
Measure	Single Arm: Apalutamide + Cetrelimab n=2 Participants Participants will be given Apalutamide tablets combined with infusions of Cetrelimab in 28-day cycles, for up maximum of two years.
Proportion of Participants With a >=50% Decline in PSA	0.5 proportion of participants

SECONDARY outcome

Timeframe: Up to 2 years

Defined as the proportion of participants with a demonstrated \>= 90% decline from baseline serum PSA confirmed by repeat measurement \>= 4 weeks after first time point at any time during the course of the study.

Outcome measures

Outcome measures
Measure	Single Arm: Apalutamide + Cetrelimab n=2 Participants Participants will be given Apalutamide tablets combined with infusions of Cetrelimab in 28-day cycles, for up maximum of two years.
Proportion of Participants With a >=90% Decline in PSA	0.5 proportion of participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Confirmatory data required to determine response was not collected.

PSA progression-free survival is defined as the time from initiation of study treatment until PSA progression as determined by PCWG3 criteria or death, whichever occurs first. Response required to determine median PFS must be confirmed by repeat measurement ≥ 4 weeks later.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

The overall survival rate is the percentage of participants still alive from date of initiation of study treatment until death from any cause or censored at time of study closure.

Outcome measures

Outcome measures
Measure	Single Arm: Apalutamide + Cetrelimab n=2 Participants Participants will be given Apalutamide tablets combined with infusions of Cetrelimab in 28-day cycles, for up maximum of two years.
Overall Survival Rate	50 percentage of participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Confirmatory data required to determine response was not collected.

From initiation of study treatment until maximal percent decline from baseline in sum of longest diameter (SLD) of target lesions by RECIST 1.1 criteria, confirmed by repeat scan ≥ 4 weeks later.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Confirmatory data required to determine response was not collected.

The length of time from a confirmed response per PCWG3 criteria until progression or death, whichever comes first.

Outcome measures

Outcome data not reported

Adverse Events

Single Arm: Apalutamide + Cetrelimab

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm: Apalutamide + Cetrelimab n=2 participants at risk Participants will be given Apalutamide tablets combined with infusions of Cetrelimab in 28-day cycles, for up maximum of two years.
Gastrointestinal disorders Diarrhea	50.0% 1/2 • Number of events 1 • Up to 2 years
Renal and urinary disorders Acute kidney injury	50.0% 1/2 • Number of events 1 • Up to 2 years
Infections and infestations Sepsis	50.0% 1/2 • Number of events 1 • Up to 2 years

Other adverse events

Other adverse events
Measure	Single Arm: Apalutamide + Cetrelimab n=2 participants at risk Participants will be given Apalutamide tablets combined with infusions of Cetrelimab in 28-day cycles, for up maximum of two years.
Renal and urinary disorders Hematuria	50.0% 1/2 • Number of events 1 • Up to 2 years
Nervous system disorders Peripheral sensory neuropathy	50.0% 1/2 • Number of events 1 • Up to 2 years
Nervous system disorders Dysgeusia	50.0% 1/2 • Number of events 2 • Up to 2 years
Musculoskeletal and connective tissue disorders Arthritis	50.0% 1/2 • Number of events 6 • Up to 2 years
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 1/2 • Number of events 1 • Up to 2 years
Investigations Weight Loss	50.0% 1/2 • Number of events 1 • Up to 2 years
Injury, poisoning and procedural complications Fall	50.0% 1/2 • Number of events 1 • Up to 2 years
Infections and infestations Sepsis	50.0% 1/2 • Number of events 1 • Up to 2 years
Infections and infestations Urinary Tract infection	100.0% 2/2 • Number of events 6 • Up to 2 years
General disorders Fatigue	100.0% 2/2 • Number of events 3 • Up to 2 years
Gastrointestinal disorders Diarrhea	50.0% 1/2 • Number of events 1 • Up to 2 years
Gastrointestinal disorders Nausea	100.0% 2/2 • Number of events 3 • Up to 2 years

Additional Information

Dr. Rahul Aggarwal, MD

University of California, San Francisco

Phone: (415) 476-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place