Is neoadjuvant nivolumab alone or with ipilimumab an option for cisplatin-ineligible muscle-invasive bladder cancer?
For patients with muscle-invasive bladder cancer (MIBC) who cannot take cisplatin, finding effective neoadjuvant therapy is important. A phase II trial tested nivolumab alone or combined with ipilimumab before cystectomy. The results show that these immunotherapy options are possible, but they have limited response rates and the combination did not perform as well as hoped.
What the research says
A phase II trial enrolled 15 patients in each cohort: one received nivolumab alone, the other received ipilimumab plus nivolumab 37. The main goal was whether patients could undergo cystectomy within 60 days after treatment. In the nivolumab-alone group, 12 of 15 patients (80%) met this goal; in the combination group, only 8 of 15 (53%) did, which failed the study's primary endpoint 37. Tumor response was modest: with nivolumab alone, 4 patients (26%) had a pathological downstaging to less than ypT2N0, including 2 complete responses (13%). With the combination, 3 patients (20%) had downstaging, with 1 complete response (7%) 37. One-year recurrence-free survival was 79% with nivolumab alone and 61% with the combination 37. The combination did not improve outcomes enough to continue the trial, and a planned third cohort was not started 37. Other options for cisplatin-ineligible patients include perioperative enfortumab vedotin plus pembrolizumab, which showed improved event-free survival in a phase 3 trial 2, and neoadjuvant sacituzumab govitecan plus pembrolizumab, which showed a 39% clinical complete response rate in a phase 2 study 6.
What to ask your doctor
- What are my options for neoadjuvant therapy if I cannot take cisplatin?
- Is nivolumab alone or with ipilimumab a reasonable choice for my case?
- What are the expected response rates and side effects of these immunotherapy regimens?
- Are there newer treatments like enfortumab vedotin plus pembrolizumab that might be more effective?
- Should I consider a clinical trial for cisplatin-ineligible MIBC?
This question is drawn from common patient questions about this topic and answered using cited medical research. We do not provide individualized advice.