OncoMatch/Clinical Trials/NCT07750067
Tunlametinib in Combination With Pucotenlimab and Hydroxychloroquine in NRAS Mutant Melanoma
Is NCT07750067 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Tunlametinib + Pucotenlimab + Hydroxychloroquine for melanoma metastatic.
Treatment: Tunlametinib + Pucotenlimab + Hydroxychloroquine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Melanoma
Biomarker criteria
Required: NRAS mutation
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-PD-1 therapy
Subjects who have previously received anti-PD-1 antibody
Cannot have received: anti-PD-L1 therapy
Subjects who have previously received anti-PD-L1/PD-L2 antibody therapy
Cannot have received: anti-PD-L2 therapy
Subjects who have previously received anti-PD-L1/PD-L2 antibody therapy
Cannot have received: VEGFR inhibitor
Subjects who have previously received ... VEGFR TKI therapy
Cannot have received: systemic chemotherapy for locally advanced or metastatic disease
Eligible subjects had not received chemotherapy for locally advanced or metastatic disease
Lab requirements
Blood counts
ANC ≥ 1.5×10^9/L, PLT ≥ 100×10^9/L, HB ≥ 9 g/dL (no transfusion within 14 days)
Kidney function
serum creatinine ≤1.5x ULN; creatinine clearance >50 mL/min (Cockcroft-Gault); urine protein ≤ 1+ or 24h protein ≤ 1g
Liver function
Serum total bilirubin (TBIL) ≤ 1.5x ULN; AST and ALT ≤2.5x ULN
Adequate bone marrow function: ANC≥ 1.5×10^9/L, PLT≥ 100×10^9/L, HB≥ 9 g/dL (no transfusion within 14 days). Serum total bilirubin (TBIL) ≤ 1.5x ULN. AST and ALT ≤2.5x ULN. Serum creatinine ≤1.5x ULN. Creatinine clearance >50 mL/min (Cockcroft-Gault). Urine protein ≤ 1+ or 24h protein ≤ 1g.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07750067 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1 therapy, anti-PD-L1 therapy, anti-PD-L2 therapy disqualifies patients from enrollment.
Does this trial require NRAS?
Yes, NRAS mutation is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages