Actively Recruiting
Axitinib and Nivolumab for the Treatment of Mucosal Melanoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-18
20
Participants Needed
2
Research Sites
258 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Axitinib and Nivolumab for the Treatment of Mucosal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic diagnosis of unresectable or advanced mucosal melanoma from head/neck, gastrointestinal, or genitourinary sites
- Measurable disease: at least 1 extracranial, unresectable, non-bony lesion measurable by imaging for initial study entry; assessable disease for triplet arms
- No prior systemic therapy for initial study entry; prior therapy limited to nivolumab plus axitinib on trial for triplet arms
- ECOG performance status of 0-2
- Asymptomatic untreated brain metastases allowed; symptomatic brain metastases treated with radiation or surgery and stable steroid use allowed
- Adequate blood counts and organ function as specified (WBC ≥ 2000/μL, ANC ≥ 1500/μL, platelets ≥ 100,000/μL, hemoglobin ≥ 9 g/dL, AST/ALT ≤ 3 × ULN, bilirubin ≤ 1.5 × ULN, GFR ≥ 30 mL/min)
- Age 18 years or older
- Females of childbearing potential and nonsterilized males sexually active must use two effective contraception methods during and after treatment as specified
You will not qualify if you...
- Active autoimmune disease or need for systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive drugs within 14 days before study drug
- History of autoimmune motor neuropathy (e.g., Guillain-Barre Syndrome, Myasthenia Gravis)
- History of myocarditis
- History or active non-infectious pneumonitis
- Other active cancers requiring systemic treatment or interfering with melanoma assessment
- Recent cardiovascular events or unstable heart conditions as specified
- Severe or recent bleeding disorders, active hemoptysis, or unstable blood clots
- Severe allergic reactions to unknown allergens or study drugs
- Serious infections such as active COVID-19 symptoms or severe bacterial infections
- Pregnant or breastfeeding women
- Genetic or autoimmune conditions causing increased sensitivity to radiation therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
A
Alexander Shoushtari, MD
CONTACT
C
Christopher Barker, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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