Metastatic MelanomaPhase 2NCT03149029
Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma
A Phase 2 study testing Pembrolizumab, Dabrafenib and Trametinib in people with Metastatic Melanoma, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
This research study is studying a combination of drugs as a possible treatment for unresectable or metastatic melanoma. The drugs involved in this study are: Pembrolizumab (Keytruda) Trametinib (Mekinist) Dabrafenib (Tafinlar) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Pembrolizumab, Dabrafenib and Trametinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Nov 2017to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants must have histologically confirmed metastatic or unresectable melanoma.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥10 mm with spiral CT scan. See section 11 for the evaluation of measureable disease.
- Participants may have previously received ipilimumab, adjuvant anti-PD1 therapy, or high-dose IL-2. They may not have previously been treated with BRAF inhibitors (vemurafenib, dabrafenib, encorafenib), MEK inhibitors (selumetinib, trametinib, binimetinib, cobimetinib), and/or anti-PD1/PDL1 monoclonal antibodies for metastatic or unresectable disease. Participants must allow 2 weeks between prior chemotherapy targeted small molecule therapy, or radiation therapy prior to study Day 1 or recovery (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.
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
- Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of the combination of trametinib with or without dabrafenib, and pembrolizumab in participants less than 18 years of age, children are excluded from this study.
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- ECOG performance status ≤1.
- Life expectancy of greater than three months.
- Participants must have normal organ and marrow function as defined below:
- Leukocytes ≥ 3,000/mcL
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- total bilirubin ≤ 1.5 X institutional upper limits of normal; total bilirubin > 1.5X above institutional upper limits of normal will be allowed if direct bilirubin is within normal limits or if patients has a documented history of Gilbert's disease
- AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
- Creatinine within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal.
- Participants must have BRAFV600-mutation status known.
- Participants must have disease amenable to and be willing to undergo serial core or excisional biopsies of a tumor lesion(s).
- Because both dabrafenib and trametinib are class D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with either dabrafenib and trametinib, breastfeeding should be discontinued if the mother is treated with either dabrafenib, trametinib, or the combination of dabrafenib and trametinib. 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. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 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.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Participants treated with prior chemotherapy, 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.
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
- Participants previously treated with BRAF inhibitors (vemurafenib, dabrafenib, encorafenib), MEK inhibitors (selumetinib, trametinib, binimetinib, cobimetinib), and/or anti-PD1/PDL1 monoclonal antibodies for metastatic or unresectable disease. Any other prior therapy will be allowed (including ipilimumab, adjuvant anti-PD1 therapy, high-dose IL-2).
- Participants with symptomatic brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Subjects with asymptomatic, stable brain metastases and/or who have been previously treated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enroll. Brain metastasis must be stable with verification by imaging (brain MRI completed at screening demonstrating no current evidence of progressive brain metastases.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
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- Patients may not be receiving any other anti-neoplastic agents.
- 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.
- Pregnant women are excluded from this study because both dabrafenib and trametinib are class D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with either dabrafenib and trametinib, breastfeeding should be discontinued if the mother is treated with either dabrafenib, trametinib, or the combination of dabrafenib and trametinib.
- Participants known to be HIV-positive and on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with either dabrafenib or trametinib. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
- Participants who have had major surgery < 2 weeks prior to entering the study.
- Has a known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to pembrolizumab or any of its excipients.
- No symptomatic or untreated leptomeningeal disease.
- Participants are not permitted to receive enzyme inducing anti-epileptic drugs.
- 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., thyroxine, insulin, or 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/active pneumonitis.
- History of current evidence of retinal vein occlusion (RVO) or retinal pigment epithelial detachment (RPED):
- History of RVO or RPED
- Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or RPED such as evidence of new optic disc cupping, evidence of visual field defects, and intraocular pressure >21 mm Hg.
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- LVEF <50% as determined by either MUGA scan or Echo
- Edema > Grade 1
- Documented myocardial infarction or unstable/uncontrolled cardiac disease (eg, unstable angina, severe arrhythmias, congestive heart failure [New York Heart Association (NYHA) > Class II]) within 6 months of study entry
- Arterial thrombosis or vascular ischemic events, such as transient ischemic attack, cerebral infarction, within 6 months prior to study entry
- Serious or non-healing wound
- History of any medical condition including cardiovascular disease or chronic obstructive pulmonary disease (COPD), that in the opinion of the investigator, may increase the risks associated with study participation or study treatments or may interfere with the conduct of the study or interpretation of study results
- Psychiatric illness/social situations that would limit compliance with study requirements
- Individuals with a history of a different malignancy are ineligible except for the following circumstances.
- Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.
- Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ and basal cell or squamous cell carcinoma of the skin.
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 30 days of planned start of study therapy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Massachusetts general Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Phase II Trial of Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Patients With Unresectable or Metastatic Melanoma
This research study is studying a combination of drugs as a possible treatment for unresectable or metastatic melanoma.
The drugs involved in this study are:
- Pembrolizumab (Keytruda)
- Trametinib (Mekinist)
- Dabrafenib (Tafinlar)
Read the detailed description
- This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
- The FDA (the U.S. Food and Drug Administration) has approved pembrolizumab, dabrafenib, and trametinib for this specific disease but the combination of all three has not been approved.
- This study is being conducted to document whether trametinib with or without dabrafenib taken for brief period of time prior to and with pembrolizumab works better than the investigators expect pembrolizumab to work in participants with unresectable and/or metastatic melanoma. All three of these drugs are FDA-approved for unresectable and/or metastatic melanoma; however, they are not FDA-approved for use all together.
- Pembrolizumab is a type of antibody that inhibits the cancer cell growth. An antibody is a cell that attaches to other cells to fight off infection.
- Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth.
- Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating.
- Conditions
- Metastatic Melanoma
- Being tested
- Pembrolizumab, Dabrafenib, Trametinib
- Keywords
- Metastatic Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab is a type of antibody that inhibits the cancer cell growth
DabrafenibDrug
Also called Tafinlar
Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating
TrametinibDrug
Also called Mekinist
Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth
| Study group | Role | What they receive |
|---|---|---|
| BRAFV600 mutant | Experimental | * Pembrolizumab administered intravenously every three weeks
* Dabrafenib taken every twelve hours orally
* Trametinib taken every twelve hours orally Receives: Drug: Pembrolizumab; Drug: Dabrafenib; Drug: Trametinib |
| BRAFV600 wild type | Experimental | * Pembrolizumab administered intravenously every three weeks
* Trametinib taken every twelve hours orally Receives: Drug: Pembrolizumab; Drug: Trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Clinical Benefit
The rate of clinical benefit is defined as the percentage of patients with stable disease, partial response, or complete response 6 months after the start of treatment per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) while remaining off MAPK-targeted therapy after induction. Response to treatment was assessed using radiographic imaging.
A partial response (PR) is defined as a decrease in the sum of the longest diameters (SLD) of target lesions greater than or equal to 30%, no new lesions, and no progression of non-target lesions.
A complete response (CR) is defined as the disappearance of all lesions and pathologic lymph nodes.
Stable disease is defined as no PR, CR, or progressive disease (PD). PD is defined as an increase in the SLD of target lesions greater than or equal to 20% in comparison with the smallest SLD on study, progression of non-target lesions, or the appearance of new lesions.
Measured: 6 months
Secondary outcomes (2)
Overall Survival at 1 Year
Overall survival is the time between the first dose of targeted therapy and death from any cause. Overall survival at 1 year is defined as the proportion of participants who were alive one year after starting treatment. For patients who were lost to follow-up or who had no documentation of death at the time of final analysis, follow-up was censored at the date of last assessment of vital status. Confidence intervals are based on log (-log(endpoint)) methodology.
Measured: 1 year
Progression Free Survival (PFS)
PFS is defined as the time from the start of study treatment until progressive disease (PD) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) criteria or death due to any cause. Participants alive without disease progression are censored at the the date of last disease evaluation. PD is defined as an increase in the SLD of target lesions greater than or equal to 20% in comparison with the smallest SLD on study, progression of non-target lesions, or the appearance of new lesions. Confidence intervals are based on log (-log(endpoint)) methodology.
Measured: Up to 62 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start27 Nov 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Ryan J Sullivan, Massachusetts General Hospital
- Investigators
- Ryan J Sullivan, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149029
- Sponsor's protocol ID
- 16-642
- Status last verified
- Aug 2026
- First submitted
- 8 May 2017
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Patients With Unresectable or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT03149029
- Acronym / sponsor ID
- 16-642
- Conditions
- Metastatic Melanoma
- Keywords
- Metastatic Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 May 2017 (actual)
- Results
- Posted 8 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying a combination of drugs as a possible treatment for unresectable or metastatic melanoma.
The drugs involved in this study are:
- Pembrolizumab (Keytruda)
- Trametinib (Mekinist)
- Dabrafenib (Tafinlar)
Detailed description
- This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
- The FDA (the U.S. Food and Drug Administration) has approved pembrolizumab, dabrafenib, and trametinib for this specific disease but the combination of all three has not been approved.
- This study is being conducted to document whether trametinib with or without dabrafenib taken for brief period of time prior to and with pembrolizumab works better than the investigators expect pembrolizumab to work in participants with unresectable and/or metastatic melanoma. All three of these drugs are FDA-approved for unresectable and/or metastatic melanoma; however, they are not FDA-approved for use all together.
- Pembrolizumab is a type of antibody that inhibits the cancer cell growth. An antibody is a cell that attaches to other cells to fight off infection.
- Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth.
- Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRAFV600 mutant | Experimental | Drug: Pembrolizumab, Drug: Dabrafenib, Drug: Trametinib* Pembrolizumab administered intravenously every three weeks * Dabrafenib taken every twelve hours orally * Trametinib taken every twelve hours orally |
| BRAFV600 wild type | Experimental | Drug: Pembrolizumab, Drug: Trametinib* Pembrolizumab administered intravenously every three weeks * Trametinib taken every twelve hours orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Participants must have histologically confirmed metastatic or unresectable melanoma.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥10 mm with spiral CT scan. See section 11 for the evaluation of measureable disease.
- Participants may have previously received ipilimumab, adjuvant anti-PD1 therapy, or high-dose IL-2. They may not have previously been treated with BRAF inhibitors (vemurafenib, dabrafenib, encorafenib), MEK inhibitors (selumetinib, trametinib, binimetinib, cobimetinib), and/or anti-PD1/PDL1 monoclonal antibodies for metastatic or unresectable disease. Participants must allow 2 weeks between prior chemotherapy targeted small molecule therapy, or radiation therapy prior to study Day 1 or recovery (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of the combination of trametinib with or without dabrafenib, and pembrolizumab in participants less than 18 years of age, children are excluded from this study.
- ECOG performance status ≤1.
Key exclusion criteria (34 listed)
- Participants treated with prior chemotherapy, 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.
- Participants previously treated with BRAF inhibitors (vemurafenib, dabrafenib, encorafenib), MEK inhibitors (selumetinib, trametinib, binimetinib, cobimetinib), and/or anti-PD1/PDL1 monoclonal antibodies for metastatic or unresectable disease. Any other prior therapy will be allowed (including ipilimumab, adjuvant anti-PD1 therapy, high-dose IL-2).
- Participants with symptomatic brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Subjects with asymptomatic, stable brain metastases and/or who have been previously treated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enroll. Brain metastasis must be stable with verification by imaging (brain MRI completed at screening demonstrating no current evidence of progressive brain metastases.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Patients may not be receiving any other anti-neoplastic agents.
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 |
|---|---|---|
| PembrolizumabAlso: KeytrudaPembrolizumab is a type of antibody that inhibits the cancer cell growth | Drug | BRAFV600 mutant, BRAFV600 wild type |
| DabrafenibAlso: TafinlarDabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating | Drug | BRAFV600 mutant |
| TrametinibAlso: MekinistTrametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth | Drug | BRAFV600 mutant, BRAFV600 wild type |
Primary outcome
The Rate of Clinical Benefit
Time frame: 6 months
The rate of clinical benefit is defined as the percentage of patients with stable disease, partial response, or complete response 6 months after the start of treatment per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) while remaining off MAPK-targeted therapy after induction. Response to treatment was assessed using radiographic imaging. A partial response (PR) is defined as a decrease in the sum of the longest diameters (SLD) of target lesions greater than or equal to 30%, no new lesions, and no progression of non-target lesions. A complete response (CR) is defined as the disappearance of all lesions and pathologic lymph nodes. Stable disease is defined as no PR, CR, or progressive disease (PD). PD is defined as an increase in the SLD of target lesions greater than or equal to 20% in comparison with the smallest SLD on study, progression of non-target lesions, or the appearance of new lesions.
2 secondary outcomes
Overall Survival at 1 Year
Time frame: 1 year
Progression Free Survival (PFS)
Time frame: Up to 62 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ryan J Sullivan, MD principal investigator
Massachusetts General Hospital
3 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 Pembrolizumab, Dabrafenib and Trametinib in people with Metastatic Melanoma, run by Massachusetts General Hospital at 3 sites 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 19 inclusion and 34 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
Yes. Results are posted in the registry (first posted 8 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Rate of Clinical Benefit (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.