Mucosal MelanomaPhase 2NCT05384496
Axitinib and Nivolumab for the Treatment of Mucosal Melanoma
A Phase 2 study testing Nivolumab and/or Ipilimumab, Stereotactic Body Radiation Therapy (SBRT) and axitinib in people with Mucosal Melanoma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucosal Melanoma
- What is being tested?
- Nivolumab and/or Ipilimumab, Stereotactic Body Radiation Therapy (SBRT) and axitinib
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 May 2022to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of unresectable or advanced mucosal melanoma arising from the head/neck (e.g. sinonasal, oral cavity, conjunctival), gastrointestinal (e.g. anorectal, esophageal), or genitourinary (e.g. vulvovaginal, urethral) sites.
- Measurable disease
- 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.
- Prior therapy
- Initial study entry: No prior systemic therapy (adjuvant or metastatic).
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- Triplet arms: Only prior systemic therapy is nivolumab + axitinib on this trial.
- ECOG performance status of 0-2.
- Asymptomatic untreated brain metastases are allowed. Symptomatic brain metastases that have undergone local therapy with RT or surgery and have not required an increase in steroid dose in prior 2 weeks are allowed.
- Screening laboratory parameters:
- White blood cell (WBC) count ≥ 2000/μL;
- Absolute neutrophil count (ANC) ≥ 1500/μL;
- Platelets ≥ 100,000/μL;
- Hemoglobin (Hgb) ≥ 9 g/dL;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN);
- Total bilirubin ≤ 1.5 × ULN (< 3 mg/dL for subjects with Gilbert's disease);
- Estimated glomerular filtration rate (GFR) ≥ 30 mL/min;either Cockcroft Gault or a cancer-specific GFR Model such as the camGFR version 2 can be used;
- Age ≥ 18 years.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 23 weeks after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. [Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).] Nonsterilized males who are sexually active with a female partner of childbearing potential must use 2 acceptable methods of effective contraception from Day 1 and for 31 weeks after receipt of the final dose of investigational product.
- Acceptable methods of effective contraception are described in the following:
- Barrier Methods (Male condom plus spermicide, cap plus spermicide, or diaphragm plus spermicide).
- Intrauterine Device Methods (Copper T, or Levonorgestrelreleasing intrauterine system (e.g., Mirena®), also considered a hormonal method).
- Hormonal Methods (Implants, hormone shot or injection, combined pill, mini pill, or Patch).
Who cannot join
- Active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain- Barre Syndrome, Myasthenia Gravis).
- History of myocarditis.
- History of, or any active evidence of non-infectious pneumonitis
- Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator.
- Cardiovascular disease, including:
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- History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary artery bypass graft (CABG) coronary angioplasty, or stenting within 6 months prior to study entry.
- Current Class II or higher congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Treatment-refractory hypertension defined as a blood pressure of systolic >150 mmHg and/or diastolic >90 mmHg despite adequate attempts at antihypertensive therapy.
- Underlying hematologic issues including:
- Congenital bleeding diathesis
- GI bleeding requiring intervention within the past 6 months
- Active hemoptysis within 42 days prior to study enrollment
- Pulmonary emboli or deep vein thromboses (DVT) that are not stable on anticoagulation regimen.
- History of severe allergic reactions to an unknown allergen or any components of the study drugs.
- Other serious infectious illnesses (e.g., active symptoms of COVID-19 infection or a post-infectious symptomatic autoimmune syndrome, serious bacterial infections requiring antibiotics).
- Women who are breastfeeding or who are pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) performed within 14 days of the first dose of study drug and by a urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours of the first dose of study drug(s).
- Genetic or autoimmune condition causing heightened radio sensitivity.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christopher Barker, MD contact
United States2 sites, 2 recruiting
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Alexander Shoushtari, MD, 646-888-4161
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Alexander Shoushtari, MD, 646-888-4161
Christopher Barker, MD, 212-639-8168
About this study
Official title: Phase 2 Study of Axitinib + PD-1 Blockade in Mucosal Melanoma With Pilot Addition of Stereotactic Body Radiotherapy or Ipilimumab in Select Progressors
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.
Read the 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
- Being tested
- Nivolumab and/or Ipilimumab, Stereotactic Body Radiation Therapy (SBRT), axitinib
- Keywords
- Axitinib, Nivolumab, PD-1 Blockade, Stereotactic Body Radiotherapy, Ipilimumab, 22-017, head/neck, sinonasal, oral cavity, conjunctival, gastrointestinal, anorectal, esophageal, genitourinary, vulvovaginal, urethral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab and/or IpilimumabDrug
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.
Stereotactic Body Radiation Therapy (SBRT)Radiation
SBRT upon local or oligometastatic progression. The prescribed dose of SBRT will be 30 Gy in 5 fractions.
axitinibDrug
5mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Axitinib and Nivolumab for the Treatment of Mucosal Melanoma | Experimental | This is a single center trial enrolling up to 20 total evaluable patients with unresectable primary or advanced mucosal melanomas arising from the head and neck, gastrointestinal, or genitourinary tract to receive frontline therapy with nivolumab IV 480mg q4 weeks plus axitinib 5mg PO twice daily. A Simon 2-stage design will be utilized. Upon progression with good tolerance, addition of stereotactive body radiation therapy (SBRT) or CTLA-4 blockade to continued nivolumab plus axitinib will be offered to patients depending on the type of progression. For patients with local or oligometastatic progression, stereotactic body radiotherapy (SBRT) will be added; for patients with progression in a site of prior radiotherapy or with multifocal or distant progression not amenable to SBRT, ipilimumab 1mg/kg IV q3 weeks for up to 4 doses will be added. Receives: Drug: Nivolumab and/or Ipilimumab; Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
best objective response
by RECIST 1.1.The Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start17 May 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single center trial enrolling up to 20 evaluable total patients.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Alexander Shoushtari, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384496
- Sponsor's protocol ID
- 22-017
- Status last verified
- Feb 2026
- First submitted
- 17 May 2022
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Axitinib + PD-1 Blockade in Mucosal Melanoma With Pilot Addition of Stereotactic Body Radiotherapy or Ipilimumab in Select Progressors
- ClinicalTrials.gov ID
- NCT05384496
- Acronym / sponsor ID
- 22-017
- Conditions
- Mucosal Melanoma
- Keywords
- Axitinib, Nivolumab, PD-1 Blockade, Stereotactic Body Radiotherapy, Ipilimumab, 22-017, head/neck, sinonasal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 17 May 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single center trial enrolling up to 20 evaluable total patients.
| Arm | Type | Receives |
|---|---|---|
| Axitinib and Nivolumab for the Treatment of Mucosal Melanoma | Experimental | Drug: Nivolumab and/or Ipilimumab, Radiation: Stereotactic Body Radiation Therapy (SBRT), Drug: axitinibThis is a single center trial enrolling up to 20 total evaluable patients with unresectable primary or advanced mucosal melanomas arising from the head and neck, gastrointestinal, or genitourinary tract to receive frontline therapy with nivolumab IV 480mg q4 weeks plus axitinib 5mg PO twice daily. A Simon 2-stage design will be utilized. Upon progression with good tolerance, addition of stereotactive body radiation therapy (SBRT) or CTLA-4 blockade to continued nivolumab plus axitinib will be offered to patients depending on the type of progression. For patients with local or oligometastatic progression, stereotactic body radiotherapy (SBRT) will be added; for patients with progression in a site of prior radiotherapy or with multifocal or distant progression not amenable to SBRT, ipilimumab 1mg/kg IV q3 weeks for up to 4 doses will be added. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologic diagnosis of unresectable or advanced mucosal melanoma arising from the head/neck (e.g. sinonasal, oral cavity, conjunctival), gastrointestinal (e.g. anorectal, esophageal), or genitourinary (e.g. vulvovaginal, urethral) sites.
- Measurable disease
- Prior therapy
- ECOG performance status of 0-2.
- Asymptomatic untreated brain metastases are allowed. Symptomatic brain metastases that have undergone local therapy with RT or surgery and have not required an increase in steroid dose in prior 2 weeks are allowed.
Key exclusion criteria (18 listed)
- Active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain- Barre Syndrome, Myasthenia Gravis).
- History of myocarditis.
- History of, or any active evidence of non-infectious pneumonitis
- Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab and/or IpilimumabCombination 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. | Drug | Axitinib and Nivolumab for the Treatment of Mucosal Melanoma |
| Stereotactic Body Radiation Therapy (SBRT)SBRT upon local or oligometastatic progression. The prescribed dose of SBRT will be 30 Gy in 5 fractions. | Radiation | Axitinib and Nivolumab for the Treatment of Mucosal Melanoma |
| axitinib5mg twice daily | Drug | Axitinib and Nivolumab for the Treatment of Mucosal Melanoma |
Primary outcome
best objective response
Time frame: 1 year
by RECIST 1.1.The Response Evaluation Criteria in Solid Tumors (RECIST)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Barker, MD contact
Alexander Shoushtari, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and/or Ipilimumab, Stereotactic Body Radiation Therapy (SBRT) and axitinib in people with Mucosal Melanoma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Shoushtari, MD (646-888-4161, shoushta@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
best objective response (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.