Phase 2 Study of Axitinib and Nivolumab Treatment for Advanced Mucosal Melanoma with Optional Radiation or Ipilimumab for Select Patients

What this Trial Is About

Researchers are investigating the combination of axitinib and nivolumab as a treatment for people with advanced or metastatic mucosal melanoma that has not received prior treatment. This study aims to evaluate whether using these two drugs together can better target proteins that help cancer cells survive and grow compared to using them separately. This is a phase 2 trial focusing on unresectable locally advanced or metastatic mucosal melanoma. Participants will receive nivolumab intravenously every 4 weeks along with axitinib taken orally twice daily. If the disease progresses but the patient tolerates treatment well, additional therapies may be added depending on progression type. For local or limited progression, stereotactic body radiation therapy SBRT will be given, and for more widespread progression or prior radiation sites, ipilimumab will be added intravenously every 3 weeks for up to four doses. The maximum duration for combined nivolumab and axitinib therapy is 104 weeks. During the study, patients will be regularly monitored through imaging to measure tumor response and other clinical assessments. The primary outcome measured is the best objective response within one year. Patients blood tests and organ functions will be evaluated to ensure safety, and those who progress on the initial treatment may be screened to join the triplet therapy phase. The total duration and timing of treatments and follow-ups will be carefully tracked throughout the trial.

Axitinib and Nivolumab for the Treatment of Mucosal Melanoma