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Sarilumab with Ipilimumab, Nivolumab, and Relatlimab for Unresectable Melanoma

This study is testing sarilumab in combination with ipilimumab, nivolumab, and relatlimab for people with stage III or IV melanoma that cannot be removed by surgery. Sarilumab is a drug approved for rheumatoid arthritis, and researchers want to see if adding it to these other melanoma treatments can reduce side effects and improve how well the treatments work. The study will look at how safe the combination is, how well you tolerate it, and how your disease responds. To join, you must be between 18 and 100 years old and meet other specific health requirements. The study aims to see if this combination can reduce serious immune-related side effects and shrink tumors.

Study design
This is a Phase II study with two stages, planning to enroll 105 patients. The first stage is a single-arm, open-label trial with up to 33 patients, and the second stage will randomize 72 patients to receive treatment with or without sarilumab.
What's involved
Participants will receive sarilumab every two weeks for 12 doses, ipilimumab every eight weeks for three doses, and nivolumab/relatlimab every four weeks for six doses, followed by maintenance treatment for up to two years.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, including side effects and tumor response, will be measured at week 24 (+/- 7 days).

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NCT05428007

Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
NYU Langone Health
~105 participants
Updated 2026-01-05 on ClinicalTrials.gov
What's tested:SarilumabIpilimumab InjectionNivolumab/Relatlimab

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Grades 3-5 Treatment-Related Immune-Related Adverse Events (irAE) per NCI CTCAE v 5.0 Criteria
Measured over week 24 (+/- 7 days)
+1 more outcome measured

Conditions

Melanoma
Unresectable Melanoma

Explore related trials

Melanoma

Where it's being run

4 sites across 3 states
Massachusetts2
California1
New York1

Study leadership

  • Janice Mehnert, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Janice Mehnert, MD
[email protected]
212-731-5431
Email the study team

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Eligibility criteria

Inclusion

Patients must have signed and dated an Institutional Review Board/Independent Ethics Committee -approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal patient care
Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.
All patients must be either Stage IIIb/c/d or Stage IV according to the American Joint Committee on Cancer (AJCC) (8th edition) and have histologically-confirmed melanoma that is felt to be surgically unresectable in order to be eligible. Please refer to the AJCC Cancer Staging Manual, 8th edition for a description of tumor, lymph node, metastasis and staging.
All melanomas, except ocular/uveal melanoma, regardless of primary site of disease will be allowed; mucosal melanomas are eligible.
Patients must not have received prior anticancer treatment for metastatic disease (for example, but not limited to, systemic, local, radiation, radiopharmaceutical).
All patients must have their disease status documented by a complete physical examination and imaging studies within 4 weeks prior to the first dose of study drug. Imaging studies must include computerized tomography (CT) scan of chest, abdomen, pelvis, and all known sites of resected disease in the setting of Stage IIIb/c/d or Stage IV disease, and brain magnetic resonance imaging (\[MRI\]; brain CT is allowable if MRI is contraindicated).
Disease must be measurable by RECIST 1.1
The complete set of baseline radiographic images must be available before treatment initiation.

Exclusion

Patients with untreated brain metastases, carcinomatosis meningitis or current ocular/uveal melanoma are excluded.
Patients with previous non-melanoma malignancies are excluded unless a complete resection or remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period (exceptions include, but are not limited to, non-melanoma skin cancers, in situ bladder cancer, in situ gastric cancer or gastrointestinal stromal tumor, in situ colon cancers, in situ cervical cancers/dysplasia, or breast carcinoma in situ).
Patients with active, known, or suspected autoimmune disease. Patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the Principal Investigator be consulted prior to signing informed consent.
Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease

What this trial measures

  • Number of Grades 3-5 Treatment-Related Immune-Related Adverse Events (irAE) per NCI CTCAE v 5.0 Criteriaweek 24 (+/- 7 days)

    The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 5.0) grades adverse events by the following scale: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Death Safety will be measured by physical examinations, vital sign measurements, Eastern Cooperative Oncology Group (ECOG) performance status evaluations, AE assessments, laboratory testing, electrocardiograms (ECGs), oxygen saturation, and concomitant medications.

  • Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Categoryweek 24 (+/- 7 days)

    Each patient will be assigned one of the following categories: 1. = Complete Response (CR) = Disappearance of all target lesions; 2. = Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. 3. = Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since treatment started. 4. = Progressive Disease (PD) = At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. 5. = Early death from malignant disease 6. = Early death from toxicity 7. = early death because of other cause 9 = Unknown (not assessable, insufficient data)