NCT05384496

Axitinib and Nivolumab for the Treatment of Mucosal Melanoma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Mucosal Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab and/or Ipilimumab	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.
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	SBRT upon local or oligometastatic progression. The prescribed dose of SBRT will be 30 Gy in 5 fractions.
DRUG	axitinib	5mg twice daily

Timeline

• Start date: 2022-05-17
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2022-05-20
• Last updated: 2026-02-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study