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Monoclonal Antibodies

Pembrolizumab + Metformin for Melanoma

Phase 1
Recruiting
Led By Yana Najjar, Md
Research Sponsored by Yana Najjar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients may have received prior adjuvant therapy with anti-PD-1, anti-CTLA-4, or BRAF/MEK inhibitors
Have a performance status of 0, 1 or 2 on the ECOG Performance Scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will test whether adding Metformin to Pembrolizumab can help fight cancer more effectively.

Who is the study for?
Adults with advanced melanoma (stage III or IV) who can provide consent and have measurable disease are eligible for this trial. They must be willing to undergo a biopsy, may be new to immunotherapy or on stable anti-PD-1 therapy, and should not have active brain metastases or diabetes requiring medication. Participants need proper organ function and cannot be pregnant, breastfeeding, or planning pregnancy.Check my eligibility
What is being tested?
The study is testing the effectiveness of Pembrolizumab (Keytruda), an existing cancer drug, in combination with Metformin versus using Pembrolizumab alone. The goal is to see if adding Metformin improves treatment outcomes for those with advanced melanoma.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as fatigue, skin reactions, diarrhea, liver inflammation; while Metformin commonly causes digestive issues like stomach pain and nausea. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have previously received certain immune or targeted therapies.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I am 18 years old or older.
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My organ functions are within normal ranges as per recent tests.
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I have recovered from radiation therapy without significant side effects.
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My cancer can be measured by scans, or I've discussed my case with the study sponsor.
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I agree to use birth control during and for 4 months after the study.
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My melanoma cannot be removed by surgery or is in an advanced stage.
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I am a woman who can have children and have a recent negative pregnancy test.
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I am using two birth control methods or am not having sex to join this study.
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I don't have active brain tumors as shown by recent scans.
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I can and agree to provide a recent biopsy of my tumor.
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I am new to immunotherapy for advanced cancer or have been on anti-PD-1 with stable or improved condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ki-67 proliferation index in T cell
Secondary outcome measures
Cell cycle status of peripheral blood T lymphocytes by Flow Cytometry
Hypoxia in the primary tumor by IHC Staining
Lymphocyte
+3 more
Other outcome measures
Correlating hypoxia measurements in the tumor with FDG avidity on PET.
Degree of mitochondrial functional restoration in TIL of patients treated with metformin and pembrolizumab compared to pembrolizumab alone
Functional restoration of peripheral blood T lymphocytes
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab and Metformin CombinationExperimental Treatment2 Interventions
Pembrolizumab (Keytruda), 200mg, by IV, every three weeks, for up to 2 years will be taken in combination with Metformin, 500mg, twice a day, for nine weeks; after the first three doses, pembrolizumab dosing can be changed to 400mg IV every 6 weeks, at the treating physician's discretion.
Group II: PembrolizumabActive Control1 Intervention
Pembrolizumab (Keytruda), 200 mg, by IV, every three weeks, for up to 2 years; after the first three doses, dosing can be changed to 400mg IV every 6 weeks, at the treating physician's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab Injection [Keytruda]
2019
Completed Phase 2
~40
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Yana NajjarLead Sponsor
5 Previous Clinical Trials
116 Total Patients Enrolled
5 Trials studying Melanoma
116 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,969 Total Patients Enrolled
120 Trials studying Melanoma
21,652 Patients Enrolled for Melanoma
Yana Najjar, Md5.01 ReviewsPrincipal Investigator - Universtiy of Pittsburgh
University of Pittsburgh
5Patient Review
I've been a patient of Dr Najjar for a couple of years now and have nothing but good things to say. She's an excellent doctor; skilled and compassionate.

Media Library

Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03311308 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any preceding experiments featured Pembrolizumab Injection [Keytruda]?

"At present, there are 1126 clinical trials being conducted on Pembrolizumab Injection [Keytruda], with 165 of those studies in the advanced Phase 3 stage. Despite Houston, Texas hosting the majority of these trials, 37594 locations across the world have opened their doors to this treatment's research."

Answered by AI

What is the current enrollment rate for this research trial?

"Affirmative. According to the clinicaltrials.gov website, this trial is currently in progress and was first posted on December 6th 2017. The most recent update was done on January 24th 2022 with a requirement of 30 participants from 1 single site."

Answered by AI

What health conditions does Pembrolizumab Injection [Keytruda] typically address?

"The injection known as Keytruda (Pembrolizumab) is traditionally prescribed to treat unresectable melanoma. Additionally, it can be utilized in cases involving microsatellite instability high and the possibility of recurrence."

Answered by AI

Can patients with certain conditions join this medical inquiry?

"Indeed, according to clinicaltrials.gov this research project is now open for enrollment. It was initially posted on December 6th 2017 and the details were most recently updated on January 24th 2022. 30 participants are needed from a single site in order to complete the trial successfully."

Answered by AI

Has the FDA sanctioned Pembrolizumab Injection [Keytruda]?

"Due to the early-stage nature of this study, our team has rated Pembrolizumab Injection's [Keytruda] safety a 1. This is based on current data that only provides limited evidence for both its efficacy and security."

Answered by AI
~7 spots leftby Jan 2026