OncoMatch/Clinical Trials/NCT01638676
A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
Is NCT01638676 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Vemurafenib and Metformin for melanoma.
Treatment: Vemurafenib · Metformin — The main purpose of this study is to evaluate the safety of Vemurafenib in combination with Metformin in melanoma patients. The phase II part of the study will also evaluate the clinical activity of the combined regiment. Based on pre-clinical studies and a phase I trial, the investigators hypothesize that the combination of an FDA-approved non-toxic dose of oral Metformin with Vemurafenib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: BRAF v600e
Disease stage
Required: Stage IIIC, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: BRAF inhibitor (vemurafenib)
Prior treatment with Vemurafenib
Cannot have received: biguanide (metformin)
Exception: previous progression of melanoma while on Metformin
Previous progression of melanoma while on Metformin
Cannot have received: radiation therapy
Exception: non CNS disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to Grade ≤ 1, except for alopecia
Received radiotherapy for non CNS disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to Grade ≤ 1, except for alopecia
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L; Platelet count ≥ 50 x 10^9/L; Hemoglobin ≥ 8 g/dL
Kidney function
Serum creatinine ≤ 2 x upper limit of normal (ULN)
Liver function
Total serum bilirubin ≤ 3 x ULN; AST/SGOT or ALT/SGPT ≤ 3x ULN, and ≤ 4 x ULN if liver metastases are present
Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- James Graham Brown Cancer Center-University of Louisville · Louisville, Kentucky
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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