Advanced MelanomaPhase 1NCT03311308
A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma
A Phase 1 study testing Pembrolizumab Injection [Keytruda] and Metformin in people with Advanced Melanoma, run by Yana Najjar at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of the combination of Pembrolizumab (KEYTRUDA®) and the investigational drug, Metformin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- Pembrolizumab Injection [Keytruda] and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2018to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. Patients without measurable disease may be included on study after discussion with the Sponsor, given that the primary endpoint of the study is Ki-67 of TIL (flow cytometry)
- Have biopsiable disease. Be willing to provide tissue from a newly obtained biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 30 days prior to initiation of treatment on Day 1.
- Patients may have received prior adjuvant therapy with anti-PD-1, anti-CTLA-4, or BRAF/MEK inhibitors.
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- Patients may be immunotherapy treatment naïve in the advanced setting or may be on anti-PD-1 therapy with SD or PR for at least 12 weeks. Patients may have received ipilimumab plus nivolumab in the metastatic setting with SD or PR for at least 12 weeks on maintenance anti-PD1.
- Have a performance status of 0, 1 or 2 on the ECOG Performance Scale.
- Have a baseline HbA1c ≤ 6.4.
- Demonstrate adequate organ function. All screening labs should be performed within 14 days of treatment initiation.
- Absolute neutrophil count (ANC) ≥1,500 /mcL
- Platelets ≥100,000 / mcL
- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
- Serum creatinine OR Measured or calculateda creatinine clearance ≤1.5 X upper limit of normal (ULN) (GFR can also be used in place of creatinine or CrCl ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN)
- Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
- Albumin >2.5 mg/dL
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Patients must be free of active brain metastases by contrast-enhanced CT/MRI scans within 2 weeks prior to starting the study drugs. If known to have prior brain metastases, must not have evidence of active (enlarging and/or symptomatic lesions) brain disease on MRI evaluation within 4 weeks from SRS or WBRT treatment.
- Patients who have received radiation may be enrolled if the treating physician determines that they have recovered from radiation and are not experiencing radiation related clinically significant adverse events.
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days from the time of registration.
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Who cannot join
- Has a current confirmed diagnosis of type 1 diabetes or type 2 diabetes that has been diagnosed by an HbA1c ≥6.5, or is on any hypoglycemic medications (insulin, metformin, etc). Patients with a screening HbA1c 6.5-7.0 may be included after discussion with the principal investigator. Patients currently on metformin will be excluded.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a known history of active TB (Bacillus Tuberculosis).
- Hypersensitivity to pembrolizumab or any of its excipients.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 (this excludes patients on anti-PD1) or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
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- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least two weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxineor physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Has an active infection requiring systemic IV antibiotic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has a known history of or is positive for hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (hepatitis C virus [HCV] RNA [qualitative] is detected). Note: Without known history, testing only needs to be performed if there is clinical suspicion for Hepatitis B or C.
- Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Profiling and Reversing Metabolic Insufficiency in the Tumor Microenvironment in Advanced Melanoma: A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma
The purpose of this study is to evaluate the effectiveness and safety of the combination of Pembrolizumab (KEYTRUDA®) and the investigational drug, Metformin.
Read the detailed description
Patients are being asked to take part in this clinical research study because they have advanced, un-resectable stage III or IV Melanoma. If they participate they will be randomized to receive Pembrolizumab (KEYTRUDA®) or the combination of Pembrolizumab (KEYTRUDA®) plus Metformin.
This research study will evaluate the effectiveness and safety of the combination of Pembrolizumab (KEYTRUDA®) and the investigational drug, Metformin.
Patients will be randomized into one of two groups - either Arm A or Arm B. In Arm A, patients will receive pembrolizumab alone. In Arm B, patients will receive both pembrolizumab and metformin.
If patients are randomized to Arm A, they will be administered pembrolizumab (200 mg), by IV, every three weeks. After the first three doses, pembrolizumab dosing can be changed to 400mg IV every 6 weeks, at the treating physician's discretion. Pembrolizumab can be administered up to two years, if disease does not progress or have unacceptable toxicity. However, if the disease progresses the patient may continue on the study if they are clinically stable or clinically improved.
If patients are randomized to Arm B, they will be administered pembrolizumab (200 mg), by IV, every three weeks, plus metformin (500 mg), twice a day for nine weeks. Metformin will be taken in the morning and evening, 12hrs apart, with food. After the first three doses, pembrolizumab dosing can be changed to 400mg IV every 6 weeks, at the treating physician's discretion.
Discontinuation of treatment may be considered for patients who have attained a confirmed complete response that have been treated for at least 24 weeks with pembrolizumab and had at least two treatments with pembrolizumab beyond the date when the initial complete response was declared.
Patients will be followed for 5 years after removal from study or until death, whichever occurs first, through standard of care visits, phone call or by medical records review.
- Conditions
- Advanced Melanoma
- Being tested
- Pembrolizumab Injection [Keytruda], Metformin
- Keywords
- Melanoma, Unresectable, Stage III, Stage IV
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab Injection [Keytruda]Drug
Also called 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.
MetforminDrug
500 mg, by mouth, twice a day for nine weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab | Active comparator | 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. Receives: Drug: Pembrolizumab Injection [Keytruda] |
| Pembrolizumab and Metformin Combination | Experimental | 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. Receives: Drug: Pembrolizumab Injection [Keytruda]; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ki-67 proliferation index in T cell
determine the cell cycle status
Measured: up to 4 years
Secondary outcomes (6)
Number of participants experiencing adverse events
Number of participants that received a combination of Pembrolizumab and Metformin who experience treatment-related adverse events as assessed by CTCAE v4.0
Measured: up to 4 years
Hypoxia in the primary tumor by IHC Staining
Measured: up to 4 years
Mitochondrial functional restoration in Tumor Infiltrating Lymphocytes by mitochondrial mass
patients treated with metformin and pembrolizumab compared to pembrolizumab alone
Measured: up to 4 years
Cell cycle status of peripheral blood T lymphocytes by Flow Cytometry
patients treated with pembrolizumab and metformin compared to patients treated with pembrolizumab alone
Measured: up to 4 years
overall tumor response rate
patients treated with metformin and pembrolizumab compared to pembrolizumab alone, as measured by clinical tumor measurement and radiological tumor measurement on PET/CT scans.
Measured: up to 4 years
Mitochondrial functional restoration in Tumor Infiltrating Lymphocytes by Seahorse metabolic profiling
patients treated with metformin and pembrolizumab compared to pembrolizumab alone
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start7 Feb 2018
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yana Najjar
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Yana Najjar, University of Pittsburgh
- Investigators
- Yana Najjar, Md, Principal investigator, Universtiy of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311308
- Sponsor's protocol ID
- HCC 16-196
- Status last verified
- Jun 2026
- First submitted
- 18 Sep 2017
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Giannitti G, Paganoni AJJ, Marchesi S, Garavaglia R, Fontana F. Mitochondrial bioenergetics and networks in melanoma: an update. Apoptosis. 2025 Oct;30(9-10):2042-2056. doi: 10.1007/s10495-025-02155-4. Epub 2025 Jul 28.
PubMed 40721981
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling and Reversing Metabolic Insufficiency in the Tumor Microenvironment in Advanced Melanoma: A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma
- ClinicalTrials.gov ID
- NCT03311308
- Acronym / sponsor ID
- HCC 16-196
- Conditions
- Advanced Melanoma
- Keywords
- Melanoma, Unresectable, Stage III, Stage IV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Yana NajjarUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness and safety of the combination of Pembrolizumab (KEYTRUDA®) and the investigational drug, Metformin.
Detailed description
Patients are being asked to take part in this clinical research study because they have advanced, un-resectable stage III or IV Melanoma. If they participate they will be randomized to receive Pembrolizumab (KEYTRUDA®) or the combination of Pembrolizumab (KEYTRUDA®) plus Metformin.
This research study will evaluate the effectiveness and safety of the combination of Pembrolizumab (KEYTRUDA®) and the investigational drug, Metformin.
Patients will be randomized into one of two groups - either Arm A or Arm B. In Arm A, patients will receive pembrolizumab alone. In Arm B, patients will receive both pembrolizumab and metformin.
If patients are randomized to Arm A, they will be administered pembrolizumab (200 mg), by IV, every three weeks. After the first three doses, pembrolizumab dosing can be changed to 400mg IV every 6 weeks, at the treating physician's discretion. Pembrolizumab can be administered up to two years, if disease does not progress or have unacceptable toxicity. However, if the disease progresses the patient may continue on the study if they are clinically stable or clinically improved.
If patients are randomized to Arm B, they will be administered pembrolizumab (200 mg), by IV, every three weeks, plus metformin (500 mg), twice a day for nine weeks. Metformin will be taken in the morning and evening, 12hrs apart, with food. After the first three doses, pembrolizumab dosing can be changed to 400mg IV every 6 weeks, at the treating physician's discretion.
Discontinuation of treatment may be considered for patients who have attained a confirmed complete response that have been treated for at least 24 weeks with pembrolizumab and had at least two treatments with pembrolizumab beyond the date when the initial complete response was declared.
Patients will be followed for 5 years after removal from study or until death, whichever occurs first, through standard of care visits, phone call or by medical records review.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab | Active comparator | Drug: Pembrolizumab Injection [Keytruda]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. |
| Pembrolizumab and Metformin Combination | Experimental | Drug: Pembrolizumab Injection [Keytruda], Drug: MetforminPembrolizumab (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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. Patients without measurable disease may be included on study after discussion with the Sponsor, given that the primary endpoint of the study is Ki-67 of TIL (flow cytometry)
- Have biopsiable disease. Be willing to provide tissue from a newly obtained biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 30 days prior to initiation of treatment on Day 1.
Key exclusion criteria (17 listed)
- Has a current confirmed diagnosis of type 1 diabetes or type 2 diabetes that has been diagnosed by an HbA1c ≥6.5, or is on any hypoglycemic medications (insulin, metformin, etc). Patients with a screening HbA1c 6.5-7.0 may be included after discussion with the principal investigator. Patients currently on metformin will be excluded.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a known history of active TB (Bacillus Tuberculosis).
- Hypersensitivity to pembrolizumab or any of its excipients.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 (this excludes patients on anti-PD1) or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pembrolizumab Injection [Keytruda]Also: Keytruda200mg, 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 | Pembrolizumab, Pembrolizumab and Metformin Combination |
| Metformin500 mg, by mouth, twice a day for nine weeks. | Drug | Pembrolizumab and Metformin Combination |
Primary outcome
Ki-67 proliferation index in T cell
Time frame: up to 4 years
determine the cell cycle status
6 secondary outcomes
Number of participants experiencing adverse events
Time frame: up to 4 years
Hypoxia in the primary tumor by IHC Staining
Time frame: up to 4 years
Mitochondrial functional restoration in Tumor Infiltrating Lymphocytes by mitochondrial mass
Time frame: up to 4 years
Cell cycle status of peripheral blood T lymphocytes by Flow Cytometry
Time frame: up to 4 years
overall tumor response rate
Time frame: up to 4 years
Mitochondrial functional restoration in Tumor Infiltrating Lymphocytes by Seahorse metabolic profiling
Time frame: up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Derived from this study: PubMed 40721981Giannitti G, Paganoni AJJ, Marchesi S, Garavaglia R, Fontana F. Mitochondrial bioenergetics and networks in melanoma: an update. Apoptosis. 2025 Oct;30(9-10):2042-2056. doi: 10.1007/s10495-025-02155-4. Epub 2025 Jul 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yana Najjar, Md principal investigator
Universtiy of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pembrolizumab Injection [Keytruda] and Metformin in people with Advanced Melanoma, run by Yana Najjar at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ki-67 proliferation index in T cell (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03311308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.