RecruitingPhase 1NCT03311308

A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma

Profiling and Reversing Metabolic Insufficiency in the Tumor Microenvironment in Advanced Melanoma: A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma


Sponsor

Yana Najjar

Enrollment

30 participants

Start Date

Feb 7, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the effectiveness and safety of the combination of Pembrolizumab (KEYTRUDA®) and the investigational drug, Metformin.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding the diabetes drug metformin to an immunotherapy drug called pembrolizumab improves outcomes for patients with advanced melanoma (a serious form of skin cancer) that cannot be surgically removed. **You may be eligible if...** - You are 18 or older with stage III or stage IV melanoma that cannot be removed by surgery - Your disease is measurable on scans - You are well enough to participate (good performance status) - You are willing to give written informed consent **You may NOT be eligible if...** - You have already received pembrolizumab or other similar immunotherapy drugs - You have serious autoimmune disease - You have uncontrolled diabetes or conditions that make metformin unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab Injection [Keytruda]

200mg, IV, every three weeks, up to two years; After the first three doses, dosing can be changed to 400mg IV every 6 weeks, at the treating physician's discretion.

DRUGMetformin

500 mg, by mouth, twice a day for nine weeks.


Locations(1)

Univ of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

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NCT03311308


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