18 and older, male only, with Small Cell Neuroendocrine Carcinoma or Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Participants With Treatment-related Adverse Events (AEs)Secondary· 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)
Group
Value
95% CI
Single Arm: Apalutamide + Cetrelimab
1.00
Proportion of Participants With a >=50% Decline in PSASecondary· 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.
Group
Value
95% CI
Single Arm: Apalutamide + Cetrelimab
0.5
Proportion of Participants With a >=90% Decline in PSASecondary· 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.
Group
Value
95% CI
Single Arm: Apalutamide + Cetrelimab
0.5
Overall Survival RateSecondary· 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.
Group
Value
95% CI
Single Arm: Apalutamide + Cetrelimab
50
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 2 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Despite the low androgen receptor (AR) transcriptional activity of treatment-emergent small cell neuroendocrine prostate cancer, there is persistent AR expression observed in the majority of treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) biopsies. This indicates that epigenetic dysregulation leads to reprogramming away from an AR-driven transcriptional program. Therefore, continuation of AR blockade in the form of apalutamide may provide additive benefit compared to immune checkpoint blockade alone. The investigators hypothesize that the combination of apalutamide plus cetrelimab will achieve a clinically significant composite response rate with sufficient durability of response in mCRPC patients with evidence of treatment-emergent small cell neuroendocrine prostate cancer
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06931340 — Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastati
· Phase 3
· recruiting
NCT07406282 — A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitor
· recruiting
NCT07086651 — A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prost
· completed
NCT06592924 — Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and S
· Phase 3
· recruiting
NCT06274047 — PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life i
· Phase 3
· recruiting
Other Rahul Aggarwal trials
Trials by the same sponsor.
NCT06942104 — Imaging of Solid Tumors Using 18F-TRX
· Phase 1
· recruiting
NCT05888532 — 64Cu-GRIP B in Patients With Advanced Malignancies
· Phase 1, PHASE2
· recruiting
NCT05011188 — FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer
· Phase 1, PHASE2
· active not recruiting
NCT04927663 — 11C-YJH08 PET Imaging for Detection of Glucocorticoid Receptor Expression
· Phase 1
· terminated
NCT04471974 — ZEN-3694, Enzalutamide, and Pembrolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer
· Phase 2
· active not recruiting
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rahul Aggarwal
Last refreshed: 15 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04926181.