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Monoclonal Antibodies

Pembrolizumab + Infliximab for Melanoma

Phase 2

Recruiting

Led By Ryan Sullivan, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients should be treatment naïve and eligible for treatment with pembrolizumab as a first line agent

Participants must have histologically confirmed Stage III unresectable or Stage IV metastatic melanoma

Must not have

Symptomatic or untreated leptomeningeal disease

Patients who are receiving other anti-neoplastic agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks up to 2 years

Summary

This trial will test a new combination therapy for metastatic melanoma. The drugs being studied are pembrolizumab and infliximab. The goal is to see if this new combination is safe and effective.

Who is the study for?

Adults over 18 with Stage III unresectable or Stage IV metastatic melanoma, who haven't been treated for it yet, or only had surgery before. They must have normal organ and marrow function, no severe heart conditions (class 2B NYHA or better), measurable disease, and understand the study. Excluded are those with ocular/mucosal melanoma, prior immunotherapy for advanced disease, active infections/autoimmune diseases needing recent treatment, certain cancer histories unless low risk of recurrence or specific minor cancers within 3 years.

What is being tested?

The trial is testing a combination of pembrolizumab (an immune therapy) and infliximab (a drug that reduces inflammation) to see if they're safe and effective against metastatic melanoma when given together compared to a placebo alongside pembrolizumab.

What are the potential side effects?

Possible side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from the drugs being administered into the vein, fatigue, digestive issues like diarrhea or colitis especially due to infliximab's action on the gut immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not received any treatment yet and can be treated with pembrolizumab.

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My melanoma is at Stage III or IV and cannot be removed by surgery.

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I am 18 years old or older.

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I have a tumor that can be measured with a scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have symptoms or untreated cancer spread to the lining of my brain and spinal cord.

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I am currently taking medication for cancer treatment.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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You have a health condition that is not under control, such as an ongoing infection, heart problems, or serious wounds that are not healing. You also have a history of certain medical conditions that could make it risky for you to participate in the study.

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I have had tuberculosis or similar infections.

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I have melanoma in my eyes or mucous membranes.

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I am currently being treated for a bacterial infection or have a systemic fungal infection.

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I am not pregnant or breastfeeding.

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I have been treated with specific immune therapies for my advanced cancer.

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I have a history of inflammatory bowel disease or related conditions.

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I have not received a live vaccine in the last 30 days.

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I experienced side effects from previous immunotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of immune-related adverse events (irAE) in patients treated with anti-PD-1 plus infliximab compared to pembrolizumab plus placebo

Secondary study objectives

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

Incidence of anti-PD-1 antibody cessation due to immune-related adverse events (irAEs)

Incidence of clinically apparent infections in patients treated with anti-PD-1 antibody plus infliximab compared to anti-PD-1 antibody plus placebo

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Anti-PD-1 therapy + PlaceboExperimental Treatment4 Interventions

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

Group II: Anti-PD-1 therapy + InfliximabExperimental Treatment4 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Relatlimab

2019

Completed Phase 2

~1150

Nivolumab

2015

Completed Phase 3

~4010