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

NCT03311308 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-06

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Pembrolizumab 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.

DRUG

Metformin

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

Sponsors & Collaborators

Principal Investigators

  • Yana Najjar, Md · Universtiy of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-07
Primary Completion
2028-01-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03311308 on ClinicalTrials.gov