ClinicalTrials.gov posted results on 2026-08-06 for NCT03991130, a terminated phase 2 trial of nivolumab with high-dose IL-2 in melanoma and metastatic renal cell carcinoma. The single-arm study enrolled 6 participants and reported 1 participant with an overall response.
Background
The study evaluated nivolumab combined with high-dose IL-2 in people with melanoma and metastatic renal cell carcinoma. The posted brief summary says the trial’s primary objective was to assess response rate, defined as complete response plus partial response, using RECIST 1.1.
Trial design
This was a single-arm phase 2 study. According to the record, patients were treated for one course past best response for a maximum of 3 courses, and response was assessed after each course of nivolumab and IL-2.
Key results
The posted results list 1 participant in the overall response rate outcome for the nivolumab and high-dose IL-2 group. The same record lists 5 participants under drug toxicity and reports a median progression-free survival of 1.4 months.
What this means
The posted data provide a very small snapshot of activity and tolerability for nivolumab plus high-dose IL-2, but the study’s terminated status and 6-person enrollment limit how much can be inferred. For clinicians and researchers, the record mainly documents that the regimen produced at least one response while toxicity was common in the reported cohort.
Source
This information is based on ClinicalTrials.gov results posted for NCT03991130 on 2026-08-06. The record is available at clinicaltrials.gov.