Metastatic MelanomaPhase 2NCT05034536
PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma
A Phase 2 study testing Pembrolizumab, Infliximab and Relatlimab in people with Metastatic Melanoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this research is to test the safety and effectiveness of the investigational combination of anti-Programmed Death (PD)-1 antibody therapy with or without LAG-3 inhibition (pembrolizumab or nivolumab+relatlimab) and infliximab in treating metastatic melanoma. 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, Infliximab and Relatlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2022to 31 Dec 2028
- Phase
- Phase 2
- 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
- Age greater than or equal to 18 years
- Participants must have histologically confirmed Stage III unresectable or Stage IV metastatic melanoma
- Patients should be treatment naïve and eligible for treatment with anti-PD-1 or anti-PD-1/LAG3 as a first line therapy (as selected by their treating physician)
- Patients previously treated for melanoma with surgical resection alone who present with recurrent Stage III unresectable or Stage IV metastatic melanoma are eligible for enrollment
- Patients who were previously treated with systemic neo-adjuvant or adjuvant anti-PD-1 therapy more than 6 months prior to study enrollment will be eligible. There are no restrictions to the use of prior BRAF targeted therapy.
- 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
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- Diagnostic imaging studies such as MRIs and CT scans must be performed within 30 days of the date of registration
- Participants must have normal organ and marrow function as defined below:
- Leukocytes (WBC) > 3,000/uL
- Absolute neutrophil count > 1,500uL
- Platelets > 100,000/uL
- 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 and ≤5 ULN for patients with liver metastases
- Baseline laboratory measurements must be documented from tests within 14 days of the date of registration
- ECOG performance status ≤ 1 (see Appendix A)
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification which can be performed by the study investigators. To be eligible for this trial, participants should be class 2B or better
- Ability to understand and willingness to sign a written informed consent document
- Baseline tumor biopsies are required for all patients who have tumors that are deemed by the study investigators to be safely accessible
Who cannot join
- Patients with ocular or mucosal melanoma
- Participants previously treated with anti-PD1/PDL1/CTLA-4 monoclonal antibodies for metastatic or unresectable disease
- Patients who are receiving other anti-neoplastic agents
- Symptomatic or untreated leptomeningeal disease
- Patients carrying a diagnosis of immunodeficiency or receiving systemic steroid therapy (prednisone or equivalent > 10 mg/day) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Corticosteroids to prevent contrast reactions is allowable
- Patients with 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
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- Prior history of inflammatory bowel disease, microscopic colitis or segmental colitis associated with diverticulosis
- Breastfeeding and pregnant women are excluded from this study since all anti-PD-1 drugs are class D agents with the potential for teratogenic or abortifacient effects.
- Uncontrolled intercurrent illness including, but not limited to:
- A. Ongoing or active infection
- B. Edema > Grade 1
- C. 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
- D. Arterial thrombosis or vascular ischemic events, such as transient ischemic attack, cerebral infarction, within 6 months prior to study entry
- E. Serious or non-healing wound
- F. 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
- G. Psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
- H. An elevated high-sensitivity troponin T level at baseline will be allowable as long as the patient has no evidence of active, clinically relevant cardiac disease.
- Patients with a history of a different malignancy are ineligible except for the following circumstances:
- A. 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
- B. 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
- Patients with a history of Hepatitis B infection (HBsAg reactive or HBCAB reactive) or Hepatitis C (HCV RNA is detected). Participants with a history of hepatitis C virus (HCV) infection may be enrolled if they have been treated and cured
- Patients with a history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidiomycosis
- Has received a live vaccine within 30 days of planned start of study therapy
- Current bacterial infection requiring antibiotic treatment, or systemic fungal infection
- Patients with a known hypersensitivity to pembrolizumab, nivolumab, or relatlimab or any of its excipients
- Previous adverse reaction or hypersensitivity to infliximab
- Any prior immune-related adverse event while on adjuvant anti-PD-1-based immunotherapy with the following exceptions: any endocrine toxicity, any grade 1 or 2 toxicity that completely resolved; if there is uncertainty about the grade of prior toxicity, this will be adjudicated by the PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
About this study
Official title: A Phase II Study of PD-1 Blockade With or Without LAG-3 Inhibition in Combination With Infliximab for the Treatment of Metastatic Melanoma and Prevention of Adverse Events
The purpose of this research is to test the safety and effectiveness of the investigational combination of anti-Programmed Death (PD)-1 antibody therapy with or without LAG-3 inhibition (pembrolizumab or nivolumab+relatlimab) and infliximab in treating metastatic melanoma.
Read the detailed description
This is a randomized, double-blind, phase 2 clinical trial that combines anti-Programmed Death (PD)-1 antibody therapy with or without LAG-3 inhibition (pembrolizumab or nivolumab+relatlimab) with the anti-Tumor Necrosis Factor (TNF)-α antibody infliximab as first line treatment for the management of patients with metastatic or recurrent melanoma.
The U.S. Food and Drug Administration (FDA) has not approved infliximab for metastatic melanoma but it has been approved for other uses. The FDA has approved pembrolizumab as a treatment option for metastatic melanoma. The FDA has approved nivolumab+relatlimab as a treatment option for metastatic melanoma.
Pembrolizumab is a blocking antibody (a protein used in the immune system to identity and neutralize bacteria, viruses, and other foreign pathogens) that binds to PD-1 (a protein that helps regulate the immune system's response in the body) and blocks the interaction with PD-L1 and PD-L2 (proteins that inhibits the body's immune response). By blocking this interaction, it might lead to an anti-tumor immune response that may decrease tumor growth.
Relatlimab is believed to work by attaching to and blocking a molecule called Lymphocyte Activation Gene-3 (LAG-3). LAG-3 is a protein that is present on different types of cells in the immune system and controls parts of the immune system by shutting it down. Scientists believe that one way cancers escape the immune system is by shutting it down. Antibodies that block LAG-3 can potentially prevent LAG-3 from shutting down the immune system, thus allowing it to recognize and help the body destroy the cancer cells.
Nivolumab is believed to work by attaching to and blocking a molecule called PD-1. PD-1 is a protein that is present on different types of cells in the immune system and controls parts of the immune system by shutting it down. Antibodies that block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus allowing it to recognize and help the body destroy the cancer cells.
Infliximab is an anti-TNFα agent (an antibody that blocks certain inflammatory hormones) that may interact with irEC (immune related (entero)colitis - inflammation that occurs in the digestive tract) which can develop among people with advanced melanoma. Anti- TNFα agents have shown to lead to rapid symptomatic improvement. By combining anti-PD-1 antibody therapy (pembrolizumab or nivolumab+relatlimab) and infliximab we believe it may lead to reduced immune related side effects while increasing effective anti-tumor immune response.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will be randomized to receive either a) anti-PD-1 antibody therapy (pembrolizumab or nivolumab+relatlimab) plus infliximab or b) anti-PD-1 antibody therapy (pembrolizumab or nivolumab+relatlimab) plus placebo (an intravenous solution without medication). Participants will receive study treatment for as long as their disease does not worsen, they do not experience any unacceptable side effects, or they have completed the two years of anti-PD-1 antibody therapy. Participants will then be followed until the study doctor determines follow-up is no longer needed or until participant withdrawal. It is expected that about 36 people will take part in this research study A research grant, The Bridge Project, is supporting this research study by providing funding for the study.
- Conditions
- Metastatic Melanoma
- Being tested
- Pembrolizumab, Infliximab, Placebo, Relatlimab, Nivolumab
- 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
Intravenous infusion
InfliximabDrug
Also called AVSOLA, Ixifi, Remicade, Renflexis
Intravenous infusion
PlaceboDrug
Intravenous infusion
RelatlimabDrug
Intravenous infusion
NivolumabDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Anti-PD-1 therapy + Infliximab | Experimental | Participants will be randomly assigned to receive physician's choice of anti-PD-1 therapy (pembrolizumab or nivolumab+relatlimab) and infliximab.
* Pembrolizumab will be administered every 3 weeks for up to 2 years
* Nivolumab+relatlimab will be administered every 4 weeks for up to 2 years
* Infliximab will be administered on weeks 0, 2, and 6 (+/- 3 days) for a total of 3 doses Receives: Drug: Pembrolizumab; Drug: Infliximab; Drug: Relatlimab; Drug: Nivolumab |
| Anti-PD-1 therapy + Placebo | Experimental | Participants will be randomly assigned to receive physician's choice of anti-PD-1 therapy (pembrolizumab or nivolumab+relatlimab) and placebo.
* Pembrolizumab will be administered every 3 weeks for up to 2 years
* Nivolumab+relatlimab will be administered every 4 weeks for up to 2 years
* Placebo. will be administered on weeks 0, 2, and 6 (+/- 3 days) for a total of 3 doses Receives: Drug: Pembrolizumab; Drug: Placebo; Drug: Relatlimab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of immune-related adverse events (irAE) in patients treated with anti-PD-1 plus infliximab compared to pembrolizumab plus placebo
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 12 weeks
Secondary outcomes (9)
Incidence of severe immune-related adverse events (irAEs) (grade 3-5) in patients treated with anti-PD-1 antibody plus infliximab compared to anti-PD-1 antibody plus placebo
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 12 weeks up to 2 years
Incidence of anti-PD-1 antibody cessation due to immune-related adverse events (irAEs)
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 12 weeks up to 2 years
Incidence of clinically apparent infections in patients treated with anti-PD-1 antibody plus infliximab compared to anti-PD-1 antibody plus placebo
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 12 weeks up to 2 years
Overall survival rate of patients receiving combination anti-PD-1 antibody/infliximab compared with anti-PD-1 antibody/placebo
Analysis based on cumulative incidence, and will include competing risks of (a) steroid initiation, or (b) anti-PD-1 antibody cessation. The methods of Fine and Gray will be used for analysis.
Measured: Time from randomization (or registration) to death due to any cause, or censored at date last known alive up to 2 years
Progression free survival rate of patients receiving combination anti-PD-1 antibody /infliximab compared with anti-PD-1 antibody/placebo
Analysis based on cumulative incidence, and will include competing risks of (a) steroid initiation, or (b) anti-PD-1 antibody cessation. The methods of Fine and Gray will be used for analysis.
Measured: Time from randomization (or registration) to the earlier of progression or death due to any cause up to 2 years.
Response rate of patients receiving combination anti-PD-1 antibody/infliximab compared with anti-PD-1 antibody/placebo
Proportion of evaluable patients who achieve either a CR or PR per RECIST criteria
Measured: Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented up to 2 years
Cumulative steroid exposure (dose x duration) used for management of irAEs for anti-PD-1 antibody/infliximab compared to anti-PD-1 antibody/placebo patients
Calculated by adding the number of doses multiplied by strength of dose over the total follow-up time. Steroid exposure will be summarized descriptively for each treatment arm and compared using a Wilcoxon rank-sum test
Measured: 12 weeks up to 2 years
Incidence of diarrhea in patients treated with anti-PD-1 antibody plus infliximab compared to anti-PD-1 antibody plus placebo
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 12 weeks up to 2 years
Incidence of colitis in patients treated with anti-PD-1 antibody plus infliximab compared to anti-PD-1 antibody plus placebo
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 12 weeks up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start7 Feb 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Ryan J Sullivan, Massachusetts General Hospital
- Investigators
- Ryan Sullivan, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034536
- Sponsor's protocol ID
- 21-077
- Status last verified
- May 2026
- First submitted
- 29 Aug 2021
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of PD-1 Blockade With or Without LAG-3 Inhibition in Combination With Infliximab for the Treatment of Metastatic Melanoma and Prevention of Adverse Events
- ClinicalTrials.gov ID
- NCT05034536
- Acronym / sponsor ID
- 21-077
- Conditions
- Metastatic Melanoma
- Keywords
- Metastatic Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Sep 2021 (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 research is to test the safety and effectiveness of the investigational combination of anti-Programmed Death (PD)-1 antibody therapy with or without LAG-3 inhibition (pembrolizumab or nivolumab+relatlimab) and infliximab in treating metastatic melanoma.
Detailed description
This is a randomized, double-blind, phase 2 clinical trial that combines anti-Programmed Death (PD)-1 antibody therapy with or without LAG-3 inhibition (pembrolizumab or nivolumab+relatlimab) with the anti-Tumor Necrosis Factor (TNF)-α antibody infliximab as first line treatment for the management of patients with metastatic or recurrent melanoma.
The U.S. Food and Drug Administration (FDA) has not approved infliximab for metastatic melanoma but it has been approved for other uses. The FDA has approved pembrolizumab as a treatment option for metastatic melanoma. The FDA has approved nivolumab+relatlimab as a treatment option for metastatic melanoma.
Pembrolizumab is a blocking antibody (a protein used in the immune system to identity and neutralize bacteria, viruses, and other foreign pathogens) that binds to PD-1 (a protein that helps regulate the immune system's response in the body) and blocks the interaction with PD-L1 and PD-L2 (proteins that inhibits the body's immune response). By blocking this interaction, it might lead to an anti-tumor immune response that may decrease tumor growth.
Relatlimab is believed to work by attaching to and blocking a molecule called Lymphocyte Activation Gene-3 (LAG-3). LAG-3 is a protein that is present on different types of cells in the immune system and controls parts of the immune system by shutting it down. Scientists believe that one way cancers escape the immune system is by shutting it down. Antibodies that block LAG-3 can potentially prevent LAG-3 from shutting down the immune system, thus allowing it to recognize and help the body destroy the cancer cells.
Nivolumab is believed to work by attaching to and blocking a molecule called PD-1. PD-1 is a protein that is present on different types of cells in the immune system and controls parts of the immune system by shutting it down. Antibodies that block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus allowing it to recognize and help the body destroy the cancer cells.
Infliximab is an anti-TNFα agent (an antibody that blocks certain inflammatory hormones) that may interact with irEC (immune related (entero)colitis - inflammation that occurs in the digestive tract) which can develop among people with advanced melanoma. Anti- TNFα agents have shown to lead to rapid symptomatic improvement. By combining anti-PD-1 antibody therapy (pembrolizumab or nivolumab+relatlimab) and infliximab we believe it may lead to reduced immune related side effects while increasing effective anti-tumor immune response.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will be randomized to receive either a) anti-PD-1 antibody therapy (pembrolizumab or nivolumab+relatlimab) plus infliximab or b) anti-PD-1 antibody therapy (pembrolizumab or nivolumab+relatlimab) plus placebo (an intravenous solution without medication). Participants will receive study treatment for as long as their disease does not worsen, they do not experience any unacceptable side effects, or they have completed the two years of anti-PD-1 antibody therapy. Participants will then be followed until the study doctor determines follow-up is no longer needed or until participant withdrawal. It is expected that about 36 people will take part in this research study A research grant, The Bridge Project, is supporting this research study by providing funding for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-PD-1 therapy + Infliximab | Experimental | Drug: Pembrolizumab, Drug: Infliximab, Drug: Relatlimab, Drug: NivolumabParticipants will be randomly assigned to receive physician's choice of anti-PD-1 therapy (pembrolizumab or nivolumab+relatlimab) and infliximab. * Pembrolizumab will be administered every 3 weeks for up to 2 years * Nivolumab+relatlimab will be administered every 4 weeks for up to 2 years * Infliximab will be administered on weeks 0, 2, and 6 (+/- 3 days) for a total of 3 doses |
| Anti-PD-1 therapy + Placebo | Experimental | Drug: Pembrolizumab, Drug: Placebo, Drug: Relatlimab, Drug: NivolumabParticipants will be randomly assigned to receive physician's choice of anti-PD-1 therapy (pembrolizumab or nivolumab+relatlimab) and placebo. * Pembrolizumab will be administered every 3 weeks for up to 2 years * Nivolumab+relatlimab will be administered every 4 weeks for up to 2 years * Placebo. will be administered on weeks 0, 2, and 6 (+/- 3 days) for a total of 3 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age greater than or equal to 18 years
- Participants must have histologically confirmed Stage III unresectable or Stage IV metastatic melanoma
- Patients should be treatment naïve and eligible for treatment with anti-PD-1 or anti-PD-1/LAG3 as a first line therapy (as selected by their treating physician)
- Patients previously treated for melanoma with surgical resection alone who present with recurrent Stage III unresectable or Stage IV metastatic melanoma are eligible for enrollment
- Patients who were previously treated with systemic neo-adjuvant or adjuvant anti-PD-1 therapy more than 6 months prior to study enrollment will be eligible. There are no restrictions to the use of prior BRAF targeted therapy.
Key exclusion criteria (27 listed)
- Patients with ocular or mucosal melanoma
- Participants previously treated with anti-PD1/PDL1/CTLA-4 monoclonal antibodies for metastatic or unresectable disease
- Patients who are receiving other anti-neoplastic agents
- Symptomatic or untreated leptomeningeal disease
- Patients carrying a diagnosis of immunodeficiency or receiving systemic steroid therapy (prednisone or equivalent > 10 mg/day) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Corticosteroids to prevent contrast reactions is allowable
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: KeytrudaIntravenous infusion | Drug | Anti-PD-1 therapy + Infliximab, Anti-PD-1 therapy + Placebo |
| InfliximabAlso: AVSOLA, Ixifi, Remicade, RenflexisIntravenous infusion | Drug | Anti-PD-1 therapy + Infliximab |
| PlaceboIntravenous infusion | Drug | Anti-PD-1 therapy + Placebo |
| RelatlimabIntravenous infusion | Drug | Anti-PD-1 therapy + Infliximab, Anti-PD-1 therapy + Placebo |
| NivolumabIntravenous infusion | Drug | Anti-PD-1 therapy + Infliximab, Anti-PD-1 therapy + Placebo |
Primary outcome
Incidence of immune-related adverse events (irAE) in patients treated with anti-PD-1 plus infliximab compared to pembrolizumab plus placebo
Time frame: 12 weeks
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
9 secondary outcomes
Incidence of severe immune-related adverse events (irAEs) (grade 3-5) in patients treated with anti-PD-1 antibody plus infliximab compared to anti-PD-1 antibody plus placebo
Time frame: 12 weeks up to 2 years
Incidence of anti-PD-1 antibody cessation due to immune-related adverse events (irAEs)
Time frame: 12 weeks up to 2 years
Incidence of clinically apparent infections in patients treated with anti-PD-1 antibody plus infliximab compared to anti-PD-1 antibody plus placebo
Time frame: 12 weeks up to 2 years
Overall survival rate of patients receiving combination anti-PD-1 antibody/infliximab compared with anti-PD-1 antibody/placebo
Time frame: Time from randomization (or registration) to death due to any cause, or censored at date last known alive up to 2 years
Progression free survival rate of patients receiving combination anti-PD-1 antibody /infliximab compared with anti-PD-1 antibody/placebo
Time frame: Time from randomization (or registration) to the earlier of progression or death due to any cause up to 2 years.
Response rate of patients receiving combination anti-PD-1 antibody/infliximab compared with anti-PD-1 antibody/placebo
Time frame: Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented up to 2 years
Cumulative steroid exposure (dose x duration) used for management of irAEs for anti-PD-1 antibody/infliximab compared to anti-PD-1 antibody/placebo patients
Time frame: 12 weeks up to 2 years
Incidence of diarrhea in patients treated with anti-PD-1 antibody plus infliximab compared to anti-PD-1 antibody plus placebo
Time frame: 12 weeks up to 2 years
Incidence of colitis in patients treated with anti-PD-1 antibody plus infliximab compared to anti-PD-1 antibody plus placebo
Time frame: 12 weeks up to 2 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 24 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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 Sullivan, MD principal investigator
Massachusetts General Hospital
1 site 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, Infliximab and Relatlimab in people with Metastatic Melanoma, run by Massachusetts General Hospital 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 19 inclusion and 27 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 24 Aug 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 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?
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?
Incidence of immune-related adverse events (irAE) in patients treated with anti-PD-1 plus infliximab compared to pembrolizumab plus placebo (time frame: 12 weeks). 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 24 Aug 2026.