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Metastatic Uveal MelanomaPhase 2NCT04552223

Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma

A Phase 2 study testing Nivolumab and Relatlimab in people with Metastatic Uveal Melanoma, run by Jose Lutzky, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Uveal Melanoma
What is being tested?
Nivolumab and Relatlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
10 Nov 2020to 4 Jan 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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.
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  • 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
  • Measured or calculated a creatinine clearance ≥30 mL/min for subject with creatinine levels > 1.5 X institutional ULN (GFR can also be used in place of creatinine or CrCl)
  • Hepatic:
  • Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
  • Aspartate Aminotransferase (AST) (SGOT) and Alanine Amino Transferase (ALT) (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
  • Albumin ≥ 2.5 mg/dL
  • Coagulation:
  • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
  • Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • Creatinine clearance should be calculated per institutional standard.
  • If a female of childbearing potential, have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • If a female of childbearing potential, be willing to use an adequate method of contraception as outlined in Section 5.8 Contraception, for the course of the study through 24 weeks after the last dose of study medication. Must abstain from ova donation for a minimum of 5 months after the end of treatment.
  • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
  • If a male of childbearing potential, agree to use an adequate method of contraception as outlined in Section 5.8- Contraception, starting with the first dose of study therapy through 7 months after the last dose of study therapy. Must abstain from sperm donation for a minimum of 24 weeks after the end of treatment.
  • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject

Who cannot join

  • 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.
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  • 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.
  • Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Are pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Have a diagnosis or known history of Human Immunodeficiency Virus (HIV), unless controlled on antiretroviral drugs and have undetectable levels of HIV antibodies.
  • Have known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C.
  • Have received a live vaccine within 30 days of planned start of study therapy.
  • Have a history of myocarditis, regardless of etiology
  • Have a troponin T (TnT) or I (TnI)
  • i) > 2x institutional upper limit of normal (ULN) : patient is excluded.
  • ii) between > 1 to 2 x ULN enrollment will be permitted if a repeat assessment remains < 2 x ULN and participant undergoes a cardiac evaluation and is cleared by a cardiologist or cardio-oncologist
  • Are patients with impaired decision-making capacity
  • Are prisoners or participants who are involuntarily incarcerated. (Note: under certain specific circumstances a person who has been imprisoned may be included as a participant. Strict conditions apply and Bristol-Myers Squibb approval is required).
  • Are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
  • Have psychological, familial, sociological, or geographical conditions that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the participant before registration in the trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: A Phase 2 Study of Nivolumab + BMS-986016 (Relatlimab) in Patients With Metastatic Uveal Melanoma

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.

Read the detailed description

This is a phase II single-institution trial with a Simon two-stage minimax design with 27 patients (13 in stage 1, 14 in stage 2) setting a 5% type I error and 80% power under true objective response rate (ORR) of 20%. The null hypothesis (ORR=5%) is rejected if 4 or more responses are observed in 27 patients. No prior PD-1, CTLA-4 and/or LAG-3 blocking antibody treatment was allowed. We will also perform single-cell mRNA and T-cell receptor (TCR) variable, diversity, and joining (V[D]J) sequencing pre-treatment and at either progression or response.

Patients will be treated with nivolumab 480 mg/relatlimab 160 mg IV q4wks to progression or intolerable toxicity for up to two years.

Being tested
Nivolumab, Relatlimab
Keywords
Metastatic Uveal Melanoma
Medical subject headings
Uveal Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called Opdivo

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

  • RelatlimabDrug

    Also called BMS-986016

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

Study groups in NCT04552223
Study groupRoleWhat they receive
Nivolumab Plus Relatlimab GroupExperimentalParticipants 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.
Receives: Drug: Nivolumab; Drug: Relatlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 24 months

Secondary outcomes (5)

  1. Disease Control Rate (DCR)

    Disease control rate (DCR) is the proportion of patients with confirmed complete response (CR), partial response (PR), or stable disease (SD) as per treating physician evaluation using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: Up to 24 months

  2. Progression-Free Survival (PFS)

    Progression-free survival (PFS) is defined as the time from the date of enrollment to the date that objective progression disease is documented or death due to any cause, whichever occurs first.

    Measured: Up to 4 years

  3. Overall Survival (OS)

    Overall survival (OS) is defined as the time from the date of enrollment to the date of death.

    Measured: Up to 4 years

  4. Duration of Response (DOR)

    Duration of response is defined as the time from the date of first documented response (CR or PR) until date of documented progression or death in the absence of disease progression.

    Measured: Up to 4 years

  5. Proportion of Study Participants With Treatment-Related Toxicity

    The safety profile of the study therapy will be determined by the proportion of study participants experiencing treatment-related adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs will be tabulated by type, grade, severity, treatment attribution according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Up to 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2020
  2. Study start10 Nov 2020
  3. Primary completion4 Jan 2024
  4. Study completion4 Jan 2026

Resources

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
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04552223
Sponsor's protocol ID
20200847
Other IDs
CA224-094, NCI-2020-11454
Status last verified
Jan 2026
First submitted
11 Sep 2020
Last updated
11 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Relatlimab in people with Metastatic Uveal Melanoma, run by Jose Lutzky, MD at 1 site 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 29 inclusion and 29 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: finished, as of the sponsor's last update on 11 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 1 site 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?

Yes. Results are posted in the registry (first posted 13 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04552223.

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 11 Feb 2026.

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