OncoMatch/Clinical Trials/NCT03311308
A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma
Is NCT03311308 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Pembrolizumab and Metformin for advanced melanoma.
Treatment: Pembrolizumab · Metformin — The purpose of this study is to evaluate the effectiveness and safety of the combination of Pembrolizumab (KEYTRUDA®) and the investigational drug, Metformin.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-cancer monoclonal antibody
Exception: excludes patients on anti-pd1
Cannot have received: chemotherapy
Cannot have received: targeted small molecule therapy
Cannot have received: radiation therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1,500 /mcL; Platelets ≥100,000 / mcL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
Kidney function
Serum creatinine OR Measured or calculated creatinine clearance ≤1.5 X ULN (GFR can also be used in place of creatinine or CrCl ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN)
Liver function
Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases; Albumin >2.5 mg/dL
Demonstrate adequate organ function. All screening labs should be performed within 14 days of treatment initiation. 1. Absolute neutrophil count (ANC) ≥1,500 /mcL 2. Platelets ≥100,000 / mcL 3. Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) 4. Serum creatinine OR Measured or calculated creatinine clearance ≤1.5 X upper limit of normal (ULN) (GFR can also be used in place of creatinine or CrCl ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN) 5. Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN 6. AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases 7. Albumin >2.5 mg/dL 8. 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Univ of Pittsburgh Medical Center Hillman Cancer Center · Pittsburgh, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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