RecruitingPhase 2NCT05384496

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

20 participants

Start Date

May 17, 2022

Study Type

INTERVENTIONAL

Conditions

Mucosal Melanoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the combination of axitinib (a drug that cuts off blood supply to tumors) and nivolumab (an immunotherapy drug) for people with mucosal melanoma — a rare and aggressive type of melanoma that grows inside body cavities such as the sinuses, mouth, digestive tract, or genitals, rather than on the skin's surface. **You may be eligible if...** - You have been diagnosed with unresectable or advanced mucosal melanoma arising from an internal body cavity - Your cancer cannot be completely removed by surgery - You have not previously received immunotherapy for this cancer - You are in reasonably good overall health **You may NOT be eligible if...** - You have an active autoimmune disease or need to take immune-suppressing medications (like high-dose steroids) - You have previously been treated with PD-1, PD-L1, or CTLA-4 immunotherapy drugs - You have active, untreated brain metastases - You are pregnant or breastfeeding - You have serious heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab 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.

RADIATIONStereotactic Body Radiation Therapy (SBRT)

SBRT upon local or oligometastatic progression. The prescribed dose of SBRT will be 30 Gy in 5 fractions.

DRUGaxitinib

5mg twice daily