Axitinib and Nivolumab for the Treatment of Mucosal Melanoma

Mucosal Melanoma Clinical Trial

Official title: Phase 2 Study of Axitinib + PD-1 Blockade in Mucosal Melanoma With Pilot Addition of Stereotactic Body Radiotherapy or Ipilimumab in Select Progressors

Status Recruiting

Clinical Trial Summary

The researchers are doing this study to find out whether the combination of axitinib and nivolumab is an effective and safe treatment for people with advanced or metastatic mucosal melanoma that has not been treated before. The researchers think that a combination of axitinib and nivolumab may help people with this disease because both drugs target and block proteins that play a role in cancer cell survival and growth. The researchers think the drugs may be more effective if given in combination rather than on their own.

Clinical Trial Description

Combination of nivolumab 3mg/kg IV every 3 weeks with ipilimumab 1mg/kg or nivolumab 480mg IV every 4 weeks as monotherapy is considered standard of care for patients with unresectable locally advanced or metastatic mucosal melanoma. SBRT upon local or oligometastatic progression is also considered standard of care in this setting. The axitinib 5mg twice daily is considered investigational. The maximum duration of maintenance nivolumab and axitinib therapy on this trial is 104 weeks from the initiation of either doublet or triplet therapy. Regardless of dose delays or omissions, the study weeks will be enumerated from the initiation of systemic therapy in the first and second line settings. Patients who progress on the doublet arm of the trial and wish to undergo screening for the triplet arm of the study will stop axitinib therapy until they are deemed eligible for enrollment and a new start date is identified for the triplet. Patients who have reduced axitinib dosing on the doublet arm are eligible to continue on the triplet arms at the same reduced dose of axitinib. The start date for the nivolumab plus ipilimumab triplet will be the initial date of infusion of ipilimumab. The start date for nivolumab plus SBRT will be the date of infusion of nivolumab. ;

Related Conditions & MeSH terms

• Melanoma
• Mucosal Melanoma

• NCT number: NCT05384496
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Alexander Shoushtari, MD
• Phone: 646-888-4161
• Email: shoushta@mskcc.org
• Status: Recruiting
• Phase: Phase 2
• Start date: May 17, 2022
• Completion date: May 2026