Trial results for a Phase 2 study evaluating nivolumab in combination with docetaxel and androgen deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (mHSPC) were posted on ClinicalTrials.gov on 2026-05-27. The study explored outcomes in patients with DNA damage repair defects (DDRD) or inflamed tumors, showing a 3-year overall survival rate of 72% in patients with inflamed tumors without DDRD.
Background
The study investigated a combination of androgen deprivation therapy (ADT), docetaxel, and nivolumab as a potential treatment for metastatic hormone-sensitive prostate cancer (mHSPC). This approach aimed to explore the efficacy of chemoimmunotherapy in specific biomarker-defined patient populations.
Trial design
The Phase 2 study (NCT04126070) enrolled 47 participants diagnosed with hormone-sensitive prostate cancer, including those with prostate adenocarcinoma and metastatic prostate adenocarcinoma. The trial evaluated a combination of androgen deprivation therapy (ADT), docetaxel, and nivolumab, stratifying participants into three cohorts based on biomarker status: DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor, Inflamed Tumor (PD-L1/CD8 High) without DDRD, and Biomarker Negative.
Key results
The trial reported several key measurements across the three cohorts:
- Percentage of Subjects With Prostate Specific Antigen (PSA) Less Than or Equal to 0.2 ng/mL at 7 Months From Start of Chemoimmunotherapy:
- COHORT 1 (DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor): 38 percentage of subjects in each cohort
- COHORT 2 (Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)): 16 percentage of subjects in each cohort
- COHORT 3 (Biomarker Negative): 15 percentage of subjects in each cohort
- Percentage of Subjects With PSA Less Than or Equal to 0.2 ng/mL During the Chemoimmunotherapy Combination:
- COHORT 1 (DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor): 50 percentage of subjects in each cohort
- COHORT 2 (Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)): 21 percentage of subjects in each cohort
- COHORT 3 (Biomarker Negative): 20 percentage of subjects in each cohort
- Best Objective Response Rate in Subjects With Measurable Disease Per RECIST 1,1 Criteria:
- COHORT 1 (DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor): 0 Participants
- COHORT 2 (Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)): 4 Participants
- COHORT 3 (Biomarker Negative): 6 Participants
- Overall Survival Rate at 3-years:
- COHORT 1 (DNA Damage Repair Defects (DDRD) +/- Inflamed Tumor): 55 percentage of subjects in each cohort (95% Confidence Interval)
- COHORT 2 (Inflamed Tumor (PD-L1/CD8 High ) Without DNA Repair Defects (DDRD)): 72 percentage of subjects in each cohort (95% Confidence Interval)
- COHORT 3 (Biomarker Negative): 59 percentage of subjects in each cohort (95% Confidence Interval)
What this means
The results from this Phase 2 study suggest varying responses to the combination of nivolumab, docetaxel, and ADT in different biomarker-defined populations of metastatic hormone-sensitive prostate cancer. Patients with inflamed tumors without DNA damage repair defects (DDRD) showed the highest 3-year overall survival rate at 72%, indicating a potential benefit for this specific subgroup. While the PSA response rates varied, the highest PSA response during chemoimmunotherapy was observed in patients with DDRD +/- inflamed tumors at 50%. These findings highlight the importance of biomarker stratification in identifying patient populations that may derive the most benefit from this combination therapy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04126070, titled "Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors", were posted on 2026-05-27 on clinicaltrials.gov.