CompletedPhase 2

Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma

United States27 participantsStarted 2020-11-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Objective Response Rate (ORR)

Timeframe: Up to 24 months

Trial details

NCT IDNCT04552223

SponsorJose Lutzky, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-04

Results submitted2024-12-24

View on ClinicalTrials.gov More Metastatic Uveal Melanoma trials