Trial results for a Phase 2 study (NCT05169684) investigating BMS-986218 in combination with Docetaxel, with or without Nivolumab, in participants with metastatic castration-resistant prostate cancer (mCRPC) were posted on ClinicalTrials.gov on 2025-06-10. The study was terminated, and results showed that the combination of BMS-986218 plus Nivolumab and Docetaxel (Treatment 2) led to a 57.1% Prostate Specific Antigen Response Rate (PSA-RR), compared to 33.3% for BMS-986218 plus Docetaxel (Treatment 1), though Treatment 2 also reported more treatment-related adverse events.
Background
The study, titled "A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer," aimed to assess the safety, efficacy, tolerability, and toxicity of different treatment combinations in men with metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel antiandrogen therapy and who had not received chemotherapy for mCRPC.
Trial design
The study (NCT05169684) was a Phase 2 trial that enrolled 10 participants. The trial investigated BMS-986218, Docetaxel, and Nivolumab in participants with Prostatic Neoplasms, Castration-Resistant. The study evaluated combinations of Docetaxel with BMS-986218 (referred to as Treatment 1 in results) or with Nivolumab plus BMS-986218 (referred to as Treatment 2 in results).
Key results
The trial reported safety and efficacy outcomes across the two treatment groups. For Prostate Specific Antigen Response Rate (PSA-RR):
- Treatment 1 (BMS-986218 + Docetaxel) showed a PSA-RR of 33.3%.
- Treatment 2 (BMS-986218 + Nivolumab + Docetaxel) showed a PSA-RR of 57.1%.
Regarding safety outcomes:
- Number of Participants With Treatment Related Adverse Events: 3 in Treatment 1 vs. 7 in Treatment 2.
- Number of Participants With Treatment Related Serious Adverse Events: 1 in Treatment 1 vs. 4 in Treatment 2.
- Number of Participants With Dose Limiting Toxicities: 1 in Treatment 1 vs. 0 in Treatment 2.
- Number of Participants With AEs Leading to Discontinuation: 2 in Treatment 1 vs. 4 in Treatment 2.
- Number of Participants Who Died: 2 in Treatment 1 vs. 2 in Treatment 2.
What this means
The termination of this Phase 2 trial, which enrolled a small number of participants, suggests that the study did not proceed as initially planned. While the combination of BMS-986218, Nivolumab, and Docetaxel (Treatment 2) demonstrated a numerically higher PSA response rate compared to BMS-986218 plus Docetaxel (Treatment 1), it was also associated with a higher incidence of treatment-related adverse events, serious adverse events, and discontinuations due to adverse events. These mixed safety and efficacy signals, combined with the trial's termination, indicate that further development of these specific combinations for mCRPC may require re-evaluation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05169684, titled "A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer," were posted on 2025-06-10 on clinicaltrials.gov.