OncoMatch/Clinical Trials/NCT03311308
A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma
Is NCT03311308 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Other
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 →Frequently asked questions
Is NCT03311308 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-cancer monoclonal antibody, chemotherapy, targeted small molecule therapy disqualifies patients from 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