Trial results for nivolumab (NCT02553642) in patients with advanced melanoma or bladder cancer were posted on ClinicalTrials.gov on 2025-07-22. The study reported a 23 percentage of participants with PR/CR for nivolumab monotherapy in bladder cancer participants.
Background
This Phase 2 study investigated nivolumab, an immunotherapy, as a monotherapy or in combination with ipilimumab, in patients with advanced melanoma or bladder cancer. The trial aimed to understand tumor characteristics and predict treatment response.
Trial design
The study (NCT02553642) was a Phase 2 trial with an enrollment of 81 participants. It investigated the relationship between tumor mutation burden and predicted neo-antigen burden in patients with advanced melanoma or bladder cancer. Participants received either nivolumab monotherapy or nivolumab plus ipilimumab combination therapy. The study's purpose was to identify features predicting response to nivolumab.
Key results
The trial reported several key measurements:
- For "Confirmed Objective Response in Bladder Cancer Participants to Nivolumab Monotherapy," the response rate was 23 percentage of participants with PR/CR.
- For "Confirmed Objective Response for Bladder Cancer Patients to Ipilimumab and Nivolumab Combination Therapy in Patients Progressing on Initial Nivolumab Monotherapy," specific participant counts were reported: 16 Participants and 53 Participants for bladder cancer patients. For melanoma cancer patients in this outcome, 0 Participants were reported for two separate instances.
- The "Tumor Mutational Burden for Evaluable Bladder Cancer Participants" showed median values of 502 mut/Mb and 92 mut/Mb, both reported with a Full Range dispersion type.
What this means
The results from this Phase 2 study provide insights into the efficacy of nivolumab in advanced bladder cancer and melanoma. The observed 23 percentage of participants with PR/CR objective response rate for nivolumab monotherapy in bladder cancer patients suggests its activity in this population. The data also explored the potential of nivolumab plus ipilimumab combination therapy and tumor mutational burden as a predictive biomarker, with specific participant counts reported for combination therapy responses and median tumor mutational burden values for bladder cancer patients. These findings contribute to understanding treatment responses and patient selection in these advanced cancers.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02553642, titled "Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated With Nivolumab or Nivolumab Plus Ipilimumab (CA209-260)," were posted on 2025-07-22 on clinicaltrials.gov.