Mitochondrial bioenergetics and networks in melanoma: an update.
Gaia Giannitti, Alyssa Julia Jennifer Paganoni, Sara Marchesi...
https://pubmed.ncbi.nlm.nih.gov/40721981Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID03311308
Profiling and Reversing Metabolic Insufficiency in the Tumor Microenvironment in Advanced Melanoma: 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
100 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
Researchers are evaluating the safety and effectiveness of combining Pembrolizumab (KEYTRUDA®) with the investigational drug Metformin in adults with advanced, unresectable stage III or IV melanoma. This study compares treatment using Pembrolizumab alone to treatment using both Pembrolizumab and Metformin to better understand potential benefits and risks. Participants will be randomly assigned to one of two groups. One group receives Pembrolizumab alone, given as a 200 mg intravenous infusion every three weeks, with an option to switch to 400 mg every six weeks after the first three doses, for up to two years. The other group receives the same Pembrolizumab dosing plus Metformin taken orally at 500 mg twice daily for nine weeks. Treatment may continue even if the disease progresses if the patient remains stable or shows improvement. During the study, participants will undergo tumor biopsies, blood tests, and monitoring through imaging and clinical assessments to evaluate immune cell activity and tumor responses. Safety will be tracked by recording side effects and other health measures. Participants will be followed for up to five years after stopping treatment or until death, through regular medical visits, phone calls, or medical record reviews to monitor long-term outcomes.
CONDITIONS
Brief Title
A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma
Who Can Participate
Age: 18Years +
All Genders
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 included after sponsor discussion if no measurable disease.
- Have biopsiable disease and be willing to provide tissue from a newly obtained tumor biopsy within 30 days prior to treatment.
- May have received prior adjuvant therapy with anti-PD-1, anti-CTLA-4, or BRAF/MEK inhibitors.
- May be immunotherapy treatment naive in advanced setting or on anti-PD-1 therapy with stable or partial response for at least 12 weeks.
- Have ECOG performance status of 0, 1, or 2.
- Have baseline HbA1c ≤ 6.4.
- Demonstrate adequate organ function as defined by specified lab values within 14 days of treatment initiation.
- Be free of active brain metastases by imaging within 2 weeks prior to study start or stable after brain treatments.
- Female patients of childbearing potential must have negative pregnancy test and use two methods of birth control or be surgically sterile.
- Male subjects must agree to use contraception starting with first dose through 120 days after last dose.
You will not qualify if you...
- Current diagnosis of type 1 or type 2 diabetes with HbA1c ≥ 6.5 or use of hypoglycemic medications including metformin.
- Immunodeficiency or systemic steroid or immunosuppressive therapy within 7 days prior to first dose.
- Known history of active tuberculosis.
- Hypersensitivity to pembrolizumab or its components.
- Recent anti-cancer monoclonal antibody treatment within 4 weeks prior to study day 1, except anti-PD1.
- Recent chemotherapy, targeted therapy, or radiation within 2 weeks prior to study day 1, unless recovered.
- Known additional malignancy requiring active treatment, except some skin cancers or in situ cervical cancer.
- Active central nervous system metastases or carcinomatous meningitis, except stable treated brain metastases.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- History or current pneumonitis requiring steroids.
- Active infection requiring systemic IV antibiotics.
- Conditions or therapies that may interfere with trial participation or safety.
- Psychiatric or substance abuse disorders interfering with cooperation.
- Pregnant, breastfeeding, or expecting to conceive or father children during trial period.
- Known history of HIV infection.
- Known history or positive test for hepatitis B or C.
- Received live vaccine within 30 days before planned study start, except inactivated flu vaccines.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 2 years
Participants receive pembrolizumab by IV every three weeks, with possible dosing changes after the first three doses. Participants in one group also take metformin by mouth twice daily for nine weeks.
Dosing visits every 3 weeks initially, then every 6 weeks after first three doses; metformin taken twice daily for nine weeks
Follow-up
Duration - Up to 5 years
Participants are followed for up to 5 years after treatment ends through standard of care visits, phone calls, or medical record reviews.
Standard care visits and periodic follow-up contacts
Trial Site Locations
Total: 1 location
1
Univ of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
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Research Team
Y
Yana Najjar, MD
A
Amy Rose, RN
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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