Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma

NCT04552223 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 20200847CA224-094NCI-2020-11454
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to test if a combination treatment of nivolumab and relatlimab will result in tumor reduction in patients with metastatic uveal melanoma.

Conditions

Metastatic Uveal Melanoma

Keywords

Metastatic Uveal Melanoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective response rate (ORR) will be the percentage of study participants with a confirmed complete response (CR) or partial response PR to study therapy as per treating physician evaluation using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  Up to 24 months

Secondary Outcomes (5)

• Disease Control Rate (DCR)

  Up to 24 months

• Progression-Free Survival (PFS)

  Up to 4 years

• Overall Survival (OS)

  Up to 4 years

• Duration of Response (DOR)

  Up to 4 years

• Proportion of Study Participants With Treatment-Related Toxicity

  Up to 25 months

Study Arms (1)

Nivolumab Plus Relatlimab Group

EXPERIMENTAL

Participants in this group will receive Nivolumab and Relatlimab administered together on Day 1 of every 4 week cycle. Both drugs will be administered until disease progression or intolerable toxicity for up to 24 months.

Drug: Nivolumab; Drug: Relatlimab

Interventions

Nivolumab DRUG

Nivolumab 480mg administered intravenously on Day 1 of each 4 week cycle.

Also known as: Opdivo

Nivolumab Plus Relatlimab Group

Relatlimab DRUG

Relatlimab 160 mg administered intravenously on Day 1 of each 4 week cycle.

Also known as: BMS-986016

Nivolumab Plus Relatlimab Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a biopsy-proven diagnosis of metastatic uveal melanoma, previously untreated with anti-PD-1,Cytotoxic T lymphocyte antigen 4 (CTLA-4) and/or lymphocyte activation gene 3 (LAG-3) blocking antibodies.
• Agree to undergo a pre-treatment and a post-treatment fresh biopsy of the tumor, if easily accessible and low-risk.
• Have completed all previous therapy for a minimum of 3 weeks before the first dose of experimental treatment. All adverse events of previous therapy must have resolved. Palliative radiation therapy to a limited field is allowed within this 3 week period.
• Be willing and able to provide written informed consent/assent for the trial.
• Be ≥ 18 years of age on day of signing informed consent.
• Have measurable disease based on RECIST 1.1.
• Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
• Left Ventricular Ejection Fraction (LVEF) assessment with documented LVEF 50% by either TTE or Multiple Gated Acquisition (MUGA) (TTE preferred test) within 6 months from first study drug administration
• Demonstrate adequate organ function as defined in Table 1. All screening labs should be performed within 10 days of treatment initiation:
• Hematological:
• Absolute neutrophil count (ANC) ≥1,500 /microliter (mcL)
• Platelets ≥100,000 / mcL
• Hemoglobin ≥ 9 g/dL or ≥5.6 mmol/L (within 7 days of assessment)
• Renal:
• Serum creatinine ≤ 1.5 X upper limit of normal (ULN) OR

You may not qualify if:

• Are currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of the first dose of treatment.
• Have a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on replacement doses of corticosteroids and patients who received steroids as pre-medication to prevent an imaging contrast allergy are allowed.
• Have a known history of active tuberculosis (Bacillus Tuberculosis)
• Have had prior treatment with a PD-1 and/or LAG-3 targeted agent
• Have hypersensitivity to nivolumab, relatlimab or any of their excipients.
• Have had a prior anti-cancer monoclonal antibody (mAb) within 3 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from clinically significant adverse events due to agents administered more than 3 weeks earlier.
• Have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 3 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from clinically significant adverse events due to a previously administered agent.
• Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
• Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Note: Patients will be allowed necessary and palliative radiation therapy to limited fields during the trial, as long as it does not encompass a target lesion.
• Have a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer, ductal carcinoma in situ (DCIS), incidentally discovered asymptomatic thyroid cancer, Prostate Specific Antigen (PSA) recurrence of prostate cancer stable on hormonal therapy with no otherwise detectable disease, and a previous diagnosis of malignancy that has shown no evidence of disease progression for 5 years or longer.
• Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis as well as a history of previous or current significant brain hemorrhage. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids to treat edema for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which will be excluded regardless of clinical stability.
• Have active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Have known history of, or any evidence of active, non-infectious pneumonitis.
• Have an active infection requiring systemic therapy.

Sponsors & Collaborators

• Jose Lutzky, MD: lead
• Bristol-Myers Squibb: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Nivolumab; relatlimab

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Jose Lutzky MD
• Organization: University of Miami

jose.lutzky@med.miami.edu

+1 (305) 6896500

Study Officials

• Jose Lutzky, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Cutaneous Malignancies

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: November 10, 2020
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2026
• Last Updated: February 11, 2026
• Results First Posted: February 13, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)