RecruitingPhase 2NCT07750067

Tunlametinib in Combination With Pucotenlimab and Hydroxychloroquine in NRAS Mutant Melanoma

Enhancing Immunogenicity in NRAS-Mutant Melanoma Via Autophagy Modulation: A Clinical and Mechanistic Study.

Sponsor

Sun Yat-sen University

Enrollment

37 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Melanoma Metastatic NRAS Mutation

Summary

This study evaluates the combination of the autophagy inhibitor hydroxychloroquine (HCQ), the MEK inhibitor tunlametinib, and the anti-PD-1 antibody pucotenlimab in patients with locally advanced or metastatic melanoma. The primary objectives are to assess the objective response rate (ORR) and progression-free survival (PFS). Secondary objectives include evaluating adverse events (type, severity, and incidence), duration of response (DOR), disease control rate (DCR), and overall survival (OS), as well as exploring the molecular mechanisms by which autophagy modulation enhances immunogenicity in mutant melanoma. Further exploratory analyses will examine the mechanisms by which autophagy inhibition enhances tumor sensitivity to PD-1 blockade, thereby establishing experimental and theoretical grounds for refining future clinical approaches.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Tunlametinib + Pucotenlimab + Hydroxychloroquine for people with melanoma metastatic and nras mutation. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTunlametinib

Tunlametinib (3 mg/tablet): The recommended dose is 12 mg (4 tablets) orally twice daily (approximately every 12 hours), with or without food. Capsules must not be chewed, dissolved, or opened. If a dose is missed, it may be taken up to 8 hours before the next scheduled dose; if the missed dose is discovered within 8 hours of the next dose, it should be skipped.

DRUGPucotenlimab

PD-1 antibody (pucotenlimab): Administered via intravenous infusion over at least 60 minutes, using an in-line filter (0.2-5 μm). The drug is diluted with normal saline prior to infusion. One treatment cycle is defined as 3 weeks (21 days).

DRUGHydroxychloroquine (HC)

Hydroxychloroquine (0.1 g/tablet): Administered orally at 2 tablets (0.2 g) twice daily, to be taken with meals or milk. Each treatment course consists of 4 consecutive weeks of administration, i.e., 30 days per course.