RecruitingPhase 2

Axitinib and Nivolumab for the Treatment of Mucosal Melanoma

United States20 participantsStarted 2022-05-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Initial study entry: Subjects must have at least 1 extracranial, unresectable, non-bony lesion that is measurable radiographically (based on RECIST 1.1).
✓. Triplet arms: assessable disease required. RECIST 1.1 measurable disease is not required.
✓. Initial study entry: No prior systemic therapy (adjuvant or metastatic).
✓. Triplet arms: Only prior systemic therapy is nivolumab + axitinib on this trial.
✓. White blood cell (WBC) count ≥ 2000/μL;
✓. Absolute neutrophil count (ANC) ≥ 1500/μL;
✓. Platelets ≥ 100,000/μL;
✓. Hemoglobin (Hgb) ≥ 9 g/dL;

What they're measuring

best objective response

Timeframe: 1 year

Trial details

NCT IDNCT05384496

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Alexander Shoushtari, MD

646-888-4161 shoushta@mskcc.org

View on ClinicalTrials.gov More Mucosal Melanoma trials