Trial results for Nivolumab in patients with high-risk biochemically recurrent prostate cancer were posted on 2026-05-08. The study observed a median time to initiation of androgen deprivation therapy (ADT) after Nivolumab treatment of 17 months for PD-L1 negative patients and 19 months for PD-L1 positive patients.
Background
Nivolumab is an immune-based cancer drug being studied for various cancer types. This particular study investigated its role in patients with high-risk biochemically recurrent prostate cancer.
Trial design
This Phase 2 study (NCT03637543) enrolled 29 participants with Prostate Cancer. The trial investigated nivolumab as a treatment for high-risk biochemically recurrent prostate cancer. The specific primary outcomes were not detailed in the posted results.
Key results
Key results from the trial include:
- The Disease Control Rate at 12 Weeks was observed in 5 participants in the PD-L1 Negative group and 4 participants in the PD-L1 Positive group.
- Regarding the maximal change in Prostate Specific Antigen (PSA) during nivolumab treatment, 8 participants in the PD-L1 Negative group and 9 participants in the PD-L1 Positive group were noted.
- The median change in PSA Doubling Time (PSADT) prior to end of treatment relative to baseline was 25 Months for the PD-L1 Negative group and 27 Months for the PD-L1 Positive group, both reported with an Inter-Quartile Range.
- The median time to radiographic progression to metastatic disease was 17 Months (95% Confidence Interval) for PD-L1 Negative patients and 14 Months (95% Confidence Interval) for PD-L1 Positive patients.
- The median time to initiation of androgen deprivation therapy (ADT) after nivolumab treatment was 17 Months (95% Confidence Interval) for the PD-L1 Negative group and 19 Months (95% Confidence Interval) for the PD-L1 Positive group.
What this means
The posted results provide initial insights into the activity of nivolumab in patients with high-risk biochemically recurrent prostate cancer. The observed median times for radiographic progression and ADT initiation, along with disease control rates, offer preliminary data on patient outcomes in this Phase 2 setting. These findings contribute to the understanding of nivolumab's potential role in this specific prostate cancer population, warranting further investigation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03637543, titled "Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer," were posted on 2026-05-08 on clinicaltrials.gov.