Actively Recruiting
Phase 2 Study of Axitinib Plus PD-1 Blockade in Advanced Mucosal Melanoma with Addition of Stereotactic Body Radiotherapy or Ipilimumab for Certain Progressions
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-18
20
Participants Needed
2
Research Sites
N/A
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
Researchers are investigating the combination of axitinib and nivolumab as a treatment for people with advanced or metastatic mucosal melanoma that has not received prior treatment. This study aims to evaluate whether using these two drugs together can better target proteins that help cancer cells survive and grow compared to using them separately. This is a phase 2 trial focusing on unresectable locally advanced or metastatic mucosal melanoma. Participants will receive nivolumab intravenously every 4 weeks along with axitinib taken orally twice daily. If the disease progresses but the patient tolerates treatment well, additional therapies may be added depending on progression type. For local or limited progression, stereotactic body radiation therapy (SBRT) will be given, and for more widespread progression or prior radiation sites, ipilimumab will be added intravenously every 3 weeks for up to four doses. The maximum duration for combined nivolumab and axitinib therapy is 104 weeks. During the study, patients will be regularly monitored through imaging to measure tumor response and other clinical assessments. The primary outcome measured is the best objective response within one year. Patients’ blood tests and organ functions will be evaluated to ensure safety, and those who progress on the initial treatment may be screened to join the triplet therapy phase. The total duration and timing of treatments and follow-ups will be carefully tracked throughout the trial.
CONDITIONS
Brief 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 one extracranial, unresectable, non-bony lesion measurable by imaging (RECIST 1.1) for initial entry; assessable disease for triplet arms
- No prior systemic therapy for initial entry; prior systemic therapy limited to nivolumab plus axitinib on this trial for triplet arms
- ECOG performance status between 0 and 2
- Asymptomatic untreated brain metastases allowed; treated symptomatic brain metastases allowed if steroids stable for 2 weeks
- Laboratory values within specified limits for white blood cells, neutrophils, platelets, hemoglobin, liver enzymes, bilirubin, and kidney function
- Age 18 years or older
- Females of childbearing potential must use two effective contraception methods if sexually active with nonsterilized males, continuing for 23 weeks after last dose; males with female partners of childbearing potential must also use two effective contraception methods from Day 1 through 31 weeks after last dose
You will not qualify if you...
- Active autoimmune disease or conditions requiring systemic corticosteroids (>10 mg prednisone daily) or immunosuppressants within 14 days
- History of autoimmune motor neuropathy such as Guillain-Barre Syndrome or Myasthenia Gravis
- History of myocarditis
- History or evidence of non-infectious pneumonitis
- Other active cancers requiring systemic treatment or interfering with melanoma assessment
- Cardiovascular diseases including recent acute coronary syndromes, heart failure Class II or higher, or treatment-resistant hypertension
- Hematologic issues including congenital bleeding disorders, recent gastrointestinal bleeding, active hemoptysis, or unstable clotting events
- History of severe allergic reactions to unknown allergens or study drugs
- Serious infections including active COVID-19 or autoimmune syndromes post-infection
- Pregnant or breastfeeding women
- Genetic or autoimmune conditions causing increased sensitivity to radiation therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 104 weeks from start of systemic therapy
Participants receive nivolumab IV every 4 weeks combined with axitinib taken orally twice daily. Upon disease progression, additional treatment with stereotactic body radiation therapy (SBRT) or ipilimumab may be added depending on progression type.
Infusions every 3 to 4 weeks with daily oral medication; additional visits for SBRT or ipilimumab if applicable
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
C
Christopher Barker, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here