Actively Recruiting
A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma
Led by Yana Najjar · Updated on 2025-05-06
30
Participants Needed
1
Research Sites
616 weeks
Total Duration
On this page
Sponsors
Y
Yana Najjar
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the effectiveness and safety of the combination of Pembrolizumab (KEYTRUDA®) and the investigational drug, Metformin.
CONDITIONS
Official Title
A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be willing and able to provide written informed consent for the trial.
- Have un-resectable (stage III) or advanced (stage IV) melanoma.
- Be 18 years of age or older on day of signing informed consent.
- Have measurable disease based on RECIST 1.1 or be approved by the Sponsor if no measurable disease.
- Have biopsiable disease with a biopsy obtained up to 30 days prior to Day 1.
- May have received prior adjuvant therapy with anti-PD-1, anti-CTLA-4, or BRAF/MEK inhibitors.
- May be immunotherapy treatment naive in the advanced setting or on anti-PD-1 therapy with stable or partial response for at least 12 weeks.
- Performance status 0, 1, or 2 on ECOG scale.
- Baseline HbA1c ≤ 6.4.
- Adequate organ function as defined by specific blood count and chemistry criteria within 14 days of treatment.
- Free of active brain metastases confirmed by CT/MRI scans within 2 weeks before starting study drugs.
- Recovered from prior radiation therapy without significant adverse events.
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before registration and be willing to use two forms of birth control or be surgically sterile.
- Male patients must agree to use contraception during and up to 120 days after treatment.
You will not qualify if you...
- Diagnosed with type 1 or type 2 diabetes with HbA1c ≥ 6.5 or currently on hypoglycemic medications, including metformin.
- Receiving systemic steroid or immunosuppressive therapy within 7 days before first dose.
- Known history of active tuberculosis.
- Hypersensitivity to pembrolizumab or its components.
- Received anti-cancer monoclonal antibody (excluding anti-PD-1) within 4 weeks before Day 1 or not recovered from related adverse events.
- Received chemotherapy, targeted therapy, or radiation within 2 weeks before Day 1 or not recovered from related adverse events, except for ≤ Grade 2 neuropathy.
- Known additional progressing malignancy requiring active treatment except certain skin cancers or cervical cancer in situ.
- Known active central nervous system metastases or carcinomatous meningitis, except stable treated brain metastases without steroids for at least 7 days.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- History of pneumonitis requiring steroids or current pneumonitis.
- Active infection requiring intravenous antibiotics.
- Any condition or abnormality interfering with study participation or results.
- Known psychiatric or substance abuse disorders interfering with trial cooperation.
- Pregnant, breastfeeding, or planning conception during study and 120 days after last dose.
- Known HIV infection.
- Known or suspected hepatitis B or C infection.
- Received live vaccine within 30 days before starting study therapy except for inactivated flu vaccines.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Univ of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
Y
Yana Najjar, MD
CONTACT
A
Amy Rose, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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