OncoMatch/Clinical Trials/NCT04114136
Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
Is NCT04114136 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab or Pembrolizumab (dependent upon approved indication) and Metformin for melanoma.
Treatment: Nivolumab or Pembrolizumab (dependent upon approved indication) · Metformin · Rosiglitazone — Patients with histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction/Gastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy, who meet eligibility criteria will undergo a biopsy (core or excisional/incisional; FNA not adequate) for baseline tissue. Patients will then be randomized to one of 3 arms: Anti-PD-1 mAb plus Metformin 500mg po BID, Anti-PD-1 mAb alone, Anti-PD-1 mAb plus Rosiglitazone 4mg po qdaily. Five weeks (+/- 7 days) after initiation of therapy a patient will undergo a repeat biopsy (core or excisional/incisional; FNA not adequate) for correlative analysis. The patient will then continue on study therapy for up to 2 years, or until progression of disease or unacceptable toxicity, whichever occurs first. RECIST 1.1 with modifications, to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Non-Small Cell Lung Carcinoma
Hepatocellular Carcinoma
Urothelial Carcinoma
Gastric Cancer
Head and Neck Squamous Cell Carcinoma
Esophageal Carcinoma
Tumor Agnostic
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-PD-1 therapy
Treatment with prior anti-PD-1 or anti-PD-L1 mAb therapy
Lab requirements
Blood counts
absolute neutrophil count ≥1,500/mcL; platelets ≥100,000/mcL
Kidney function
Creatinine clearance ≥40 mL/min/1.73 m2
Liver function
total bilirubin ≤ institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN
Patients must have normal organ and marrow function as defined below: absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN Creatinine clearance ≥40 mL/min/1.73 m2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania
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