Trial results for a Phase 1/2 study evaluating intratumoral hu14.18-IL2 with radiation, nivolumab, and ipilimumab for melanoma were posted on ClinicalTrials.gov on 2026-06-03. The study, NCT03958383, was terminated, and reported no clinical benefit in the enrolled participants. A total of 8 participants were enrolled in the trial.
Background
The study investigated intratumoral hu14.18-IL2, a fusion protein, in combination with radiation therapy, nivolumab, and ipilimumab for patients with advanced (stage IV) or surgically incurable melanoma. Nivolumab and ipilimumab are immunotherapeutic agents commonly used in melanoma treatment. The trial aimed to evaluate the safety and potential efficacy of this multi-modal approach.
Trial design
The Phase 1/2 study (NCT03958383) enrolled 8 participants with melanoma. The trial was designed to determine the maximum tolerated dose or maximum administered dose of intratumoral hu14.18-IL2, and to evaluate side effects when given alone, after radiation therapy, and in combination with nivolumab and ipilimumab.
Key results
The trial reported the following key measurements before its termination:
- For Incidence of Adverse Events:
- Phase IA reported 1 event, 0 events, and 0 events across different measurements.
- Phase IB reported 1 event, 0 events, and 1 event across different measurements.
- The Maximum Tolerated Dose (MTD) in Phase IA was determined to be 2 milligrams per meter squared. MTD for Phase IB was not applicable.
- The Maximum Administered Dose (MAD) was 2 milligrams per meter squared in Phase IA and 1 milligram per meter squared in Phase IB.
- Clinical Benefit (CB) was observed in 0 participants in Phase IA and 0 participants in Phase IB.
What this means
The termination of this Phase 1/2 study for melanoma, coupled with the reported no clinical benefit in any participant across both phases, indicates that the experimental regimen did not achieve its desired therapeutic effect. While maximum tolerated and administered doses were determined for Phase IA, the absence of clinical benefit and the termination of the trial suggest that this particular combination of hu14.18-IL2 with radiation, nivolumab, and ipilimumab may not be a viable treatment strategy for advanced or surgically incurable melanoma. The adverse event data, while reported, is not detailed enough to draw specific safety conclusions without further context on the nature and severity of these events.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03958383, titled 'IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma', were posted on 2026-06-03 on clinicaltrials.gov.