Tunlametinib in Combination With Pucotenlimab and Hydroxychloroquine in NRAS Mutant Melanoma

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 i

Trial Details

NCT ID
NCT07750067
Phase
PHASE2
Sponsor
Sun Yat-sen University
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Tunlametinib
  • Pucotenlimab
  • Hydroxychloroquine (HC)
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Age ≥ 18 years of age, both genders.
  • Subjects with unresectable or metastatic melanoma (Stage III/IV) confirmed by histology or cytology
  • The mutated NRAS genes were confirmed by sequencing.
  • Prior systemic antineoplastic therapy is allowed. All acute toxic effects of prior antitumor therapy must have resolved to grade 1 or lower before …

For full eligibility, visit ClinicalTrials.gov.

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