Metastatic Melanoma (Stage IIIC Non-résécable or no Surgically Curable or Stage IV With Classification AJCC)Phase 2NCT01840007
Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma
A Phase 2 study testing Metformin Group in people with Metastatic Melanoma (Stage IIIC Non-résécable or no Surgically Curable or Stage IV With Classification AJCC), run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
In western countries, melanoma represents a major mistake of public health by its frequency, lethality and the increasing of incidence. Surgery can cure melanoma diagnosed very early. In other cases, it exists a risk of recurrence of lymph node and visceral. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma (Stage IIIC Non-résécable or no Surgically Curable or Stage IV With Classification AJCC)
- What is being tested?
- Metformin Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Aug 2011to 18 Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Major patients with metastatic melanoma (stage IIIC non-résécable or no surgically curable or stage IV with classification AJCC) in progression after a first-line of treatment by vemurafenib or chemotherapy, and non-eligible or non-responders to ipilimumab.
- Metastases measurable by RECIST criteria. Hematologic, renal and hepatic appropriate functions. Negative pregnancy test.
Who cannot join
- Patients with symptomatic brain metastases and Performans Status (PS)>2. Patients with carcinomatous meningitis. Pregnant or breathfeeding women. Patients with a contraindication to the metformine. HIV infection, active infection with HBV or HCV. Patients already treated with metformin in the context of diabetes.
Trial locations and contacts
2 sites in 1 country.
France2 sites
MORTIER Laurent
Lille, Nord, 59000
Bahadoran
Nice, Alpes-Maritimes, 06200
About this study
In western countries, melanoma represents a major mistake of public health by its frequency, lethality and the increasing of incidence. Surgery can cure melanoma diagnosed very early. In other cases, it exists a risk of recurrence of lymph node and visceral. At the stage of visceral metastases, the prognosis of melanoma is catastrophic, with a median survival of 6 months. Indeed, the reference chemotherapy by dacarbazine induces a very limited response rate of 10-20%, the ipilimumab which has been authorized in the second intention, has a response rate of 10%, and other available treatments don't have a superior efficiency. Metformin is an oral antidiabetic of biguanides family which acts by inducing the activation of AMPK, a molecule which is inactivated in many cancers including the melanoma. In agreement with these data, several preclinical studies suggested that metformin has antineoplastic activity. In the case of melanoma, a study published recently has showed that metformin inhibits proliferation of melanoma cells in vitro and we confirmed for our part these results in our laboratory (INSERM U895).
- Being tested
- Metformin Group
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin GroupDrug
The chosen posology is 2540 mg/day of metformin-base so 3 tablets/day of Glucophage ® 1000.
Patients should take 3 tablets/day at the rate of 1tablet in morning, noon and evening to favor the absorbtion and reduce the risk of gastrointestinal intolerance. In case of missed dose, patients will be allowed to take 2 tablets on the next grip. The drug will be presented in its officinale form of Glucophage ® 1000 with specifications indicated in the Vidal dictionary. It will be provided each month, to patient, 3 boxes of 30 tablets of Glucophage ® 1000. The patient will be asked to rate each day, on a calendar, the number of tablets of Glucophage ® 1000 effectively taken. It will also ask to the patient to bring back used boxes of Glucophage ® 1000 to count any tablets not taken.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | The chosen posology is 2540 mg/day of metformin-base so 3 tablets/day of Glucophage ® 1000.
Patients should take 3 tablets/day at the rate of 1tablet in morning, noon and evening to favor the absorbtion and reduce the risk of gastrointestinal intolerance. In case of missed dose, patients will be allowed to take 2 tablets on the next grip. The drug will be presented in its officinale form of Glucophage ® 1000 with specifications indicated in the Vidal dictionary. It will be provided each month, to patient, 3 boxes of 30 tablets of Glucophage ® 1000. The patient will be asked to rate each day, on a calendar, the number of tablets of Glucophage ® 1000 effectively taken. It will also ask to the patient to bring back used boxes of Glucophage ® 1000 to count any tablets not taken. Receives: Drug: Metformin Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
The primary evaluation criteria is the response rate (response rate, RR) defined by the ratio between the total number of patients with a complete response (complete response, CR) or partial (partial response, PR) and the total number of patients in the study. Partial or complete responses will be defined by RECIST 1.1 (15) criteria :
- Complete response: disappearance of all targets lesions
- Partial response: decrease of at least 30% of the sum of the biggest diameters of each target lesion All others patients, including those for who the response couldn't be measured, will be considered non-responders.
Measured: Once time after 6 months of treatment by metformine
Secondary outcomes (1)
the overall survival, the survival without progress (PFS), the tolerance, and the quality of life.
- Overall survival (OS) is defined by the duration (number of days) between the start of treatment (J1) and the date of death from anything.
- Progression-free survival (PFS) is defined by the duration (number of days) between the start of treatment (J1) and the observation of a progression or death. Tumor progression is defined by an increase of at least 20% of the sum of the biggest diameters of each target lesion.
- The duration of the response is determined by the time (in days) between the date (visit) which is recorded a response to the treatment (complete or partial) and the date (visit) which is recorded an increase or the date of death.
- To evaluate the quality of life, a questionnaire EORTC QLQ-C30 version 3 (16), validated in French, will be completed by the patient at visits V1 (J1), V3 (M2), V5 (M4) and V7 (M6) (Annex X).
Measured: 6 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study start30 Aug 2011
- Primary completion28 May 2015
- Study completion18 Nov 2015
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 Metastatic Melanoma (Stage IIIC Non-résécable or no Surgically Curable or Stage IV With Classification AJCC)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BAHADORAN Philippe, PHD, Principal investigator, Service de Dermatologie - Hôpital de l'Archet - CHU de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840007
- Sponsor's protocol ID
- 10-PP-17
- Other IDs
- 2010-024322-38
- Status last verified
- Feb 2013
- First submitted
- 23 Apr 2013
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Montaudie H, Cerezo M, Bahadoran P, Roger C, Passeron T, Machet L, Arnault JP, Verneuil L, Maubec E, Aubin F, Granel F, Giacchero D, Hofman V, Lacour JP, Maryline A, Ballotti R, Rocchi S. Metformin monotherapy in melanoma: a pilot, open-label, prospective, and multicentric study indicates no benefit. Pigment Cell Melanoma Res. 2017 May;30(3):378-380. doi: 10.1111/pcmr.12576. Epub 2017 Apr 22. No abstract available.
PubMed 28122176
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma
- ClinicalTrials.gov ID
- NCT01840007
- Acronym / sponsor ID
- 10-PP-17
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 30 Aug 2011 (actual)
- Primary completion
- 28 May 2015 (actual)
- Study completion
- 18 Nov 2015 (actual)
- First posted
- 25 Apr 2013 (estimated)
- 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.
In western countries, melanoma represents a major mistake of public health by its frequency, lethality and the increasing of incidence. Surgery can cure melanoma diagnosed very early. In other cases, it exists a risk of recurrence of lymph node and visceral. At the stage of visceral metastases, the prognosis of melanoma is catastrophic, with a median survival of 6 months. Indeed, the reference chemotherapy by dacarbazine induces a very limited response rate of 10-20%, the ipilimumab which has been authorized in the second intention, has a response rate of 10%, and other available treatments don't have a superior efficiency. Metformin is an oral antidiabetic of biguanides family which acts by inducing the activation of AMPK, a molecule which is inactivated in many cancers including the melanoma. In agreement with these data, several preclinical studies suggested that metformin has antineoplastic activity. In the case of melanoma, a study published recently has showed that metformin inhibits proliferation of melanoma cells in vitro and we confirmed for our part these results in our laboratory (INSERM U895).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin GroupThe chosen posology is 2540 mg/day of metformin-base so 3 tablets/day of Glucophage ® 1000. Patients should take 3 tablets/day at the rate of 1tablet in morning, noon and evening to favor the absorbtion and reduce the risk of gastrointestinal intolerance. In case of missed dose, patients will be allowed to take 2 tablets on the next grip. The drug will be presented in its officinale form of Glucophage ® 1000 with specifications indicated in the Vidal dictionary. It will be provided each month, to patient, 3 boxes of 30 tablets of Glucophage ® 1000. The patient will be asked to rate each day, on a calendar, the number of tablets of Glucophage ® 1000 effectively taken. It will also ask to the patient to bring back used boxes of Glucophage ® 1000 to count any tablets not taken. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major patients with metastatic melanoma (stage IIIC non-résécable or no surgically curable or stage IV with classification AJCC) in progression after a first-line of treatment by vemurafenib or chemotherapy, and non-eligible or non-responders to ipilimumab.
- Metastases measurable by RECIST criteria. Hematologic, renal and hepatic appropriate functions. Negative pregnancy test.
Key exclusion criteria (1 listed)
- Patients with symptomatic brain metastases and Performans Status (PS)>2. Patients with carcinomatous meningitis. Pregnant or breathfeeding women. Patients with a contraindication to the metformine. HIV infection, active infection with HBV or HCV. Patients already treated with metformin in the context of diabetes.
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 |
|---|---|---|
| Metformin GroupThe chosen posology is 2540 mg/day of metformin-base so 3 tablets/day of Glucophage ® 1000. Patients should take 3 tablets/day at the rate of 1tablet in morning, noon and evening to favor the absorbtion and reduce the risk of gastrointestinal intolerance. In case of missed dose, patients will be allowed to take 2 tablets on the next grip. The drug will be presented in its officinale form of Glucophage ® 1000 with specifications indicated in the Vidal dictionary. It will be provided each month, to patient, 3 boxes of 30 tablets of Glucophage ® 1000. The patient will be asked to rate each day, on a calendar, the number of tablets of Glucophage ® 1000 effectively taken. It will also ask to the patient to bring back used boxes of Glucophage ® 1000 to count any tablets not taken. | Drug | Metformin |
Primary outcome
Response rate
Time frame: Once time after 6 months of treatment by metformine
The primary evaluation criteria is the response rate (response rate, RR) defined by the ratio between the total number of patients with a complete response (complete response, CR) or partial (partial response, PR) and the total number of patients in the study. Partial or complete responses will be defined by RECIST 1.1 (15) criteria : * Complete response: disappearance of all targets lesions * Partial response: decrease of at least 30% of the sum of the biggest diameters of each target lesion All others patients, including those for who the response couldn't be measured, will be considered non-responders.
1 secondary outcome
the overall survival, the survival without progress (PFS), the tolerance, and the quality of life.
Time frame: 6 times
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Results publication: PubMed 28122176Montaudie H, Cerezo M, Bahadoran P, Roger C, Passeron T, Machet L, Arnault JP, Verneuil L, Maubec E, Aubin F, Granel F, Giacchero D, Hofman V, Lacour JP, Maryline A, Ballotti R, Rocchi S. Metformin monotherapy in melanoma: a pilot, open-label, prospective, and multicentric study indicates no benefit. Pigment Cell Melanoma Res. 2017 May;30(3):378-380. doi: 10.1111/pcmr.12576. Epub 2017 Apr 22. No abstract available.
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.
BAHADORAN Philippe, PHD principal investigator
Service de Dermatologie - Hôpital de l'Archet - CHU de Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin Group in people with Metastatic Melanoma (Stage IIIC Non-résécable or no Surgically Curable or Stage IV With Classification AJCC), run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rate (time frame: Once time after 6 months of treatment by metformine). 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 NCT01840007, 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 31 Mar 2026.