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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
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, 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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 had surgery for melanoma and now have Stage III or IV melanoma that cannot be removed with surgery.
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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.
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I was treated with anti-PD-1 therapy over 6 months ago.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of immune-related adverse events (irAE) in patients treated with pembrolizumab plus infliximab compared to pembrolizumab plus placebo
Secondary outcome measures
Cumulative steroid exposure (dose x duration) used for management of irAEs for pembrolizumab/infliximab compared to pembrolizumab/placebo patients
Incidence of clinically apparent infections in patients treated with pembrolizumab plus infliximab compared to pembrolizumab plus placebo
Incidence of colitis in patients treated with pembrolizumab plus infliximab compared to pembrolizumab plus placebo
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pembrolizumab + PlaceboExperimental Treatment2 Interventions
Participants will be randomly assigned to receive pembrolizumab and placebo. Pembrolizumab will be administered every 3 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: Pembrolizumab + InfliximabExperimental Treatment2 Interventions
Participants will be randomly assigned to receive pembrolizumab and infliximab. Pembrolizumab will be administered every 3 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
Pembrolizumab
2017
Completed Phase 2
~2010
Placebo
1995
Completed Phase 3
~2670
Infliximab
2017
Completed Phase 4
~3280

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,193,387 Total Patients Enrolled
22 Trials studying Melanoma
1,063 Patients Enrolled for Melanoma
Massachusetts Institute of TechnologyOTHER
97 Previous Clinical Trials
12,729,951 Total Patients Enrolled
Ryan Sullivan, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
256 Total Patients Enrolled
2 Trials studying Melanoma
256 Patients Enrolled for Melanoma

Media Library

Infliximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05034536 — Phase 2
Infliximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05034536 — Phase 2
Melanoma Research Study Groups: Pembrolizumab + Infliximab, Pembrolizumab + Placebo
Melanoma Clinical Trial 2023: Infliximab Highlights & Side Effects. Trial Name: NCT05034536 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an estimate of the number of individuals who are participating in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this research endeavour is actively recruiting participants and was initially posted on February 7th 2022 before being updated lastly on April 6th. The trial requires 36 patients to be recruited from one medical centre."

Answered by AI

In what situations is Pembrolizumab most frequently prescribed?

"Pembrolizumab is often utilized to treat psoriasis, yet its efficacy has been demonstrated in cases like unresectable melanoma, microsatellite instability high tumors and malignant neoplasms."

Answered by AI

Is there any significant risk associated with the administration of Pembrolizumab?

"The safety of Pembrolizumab is estimated to be a 2 due to the limited data available from this Phase 2 trial. While there are some findings that support its security, efficacy has yet to be confirmed."

Answered by AI

Are there any prior precedents for the utilization of Pembrolizumab in clinical research?

"Currently, there are 1,008 clinical studies dedicated to studying Pembrolizumab. Of these trials, 131 have reached Phase 3 testing. While the majority of locations where research is conducted on Pembrolizumab lie in Scottsdale, Arizona, it can be found in 36146 sites worldwide."

Answered by AI

Is the enrollment process for this trial still open?

"Data on clinicaltrials.gov corroborates that recruitment for this medical trial is ongoing, with the study initially posted in February 2022 and last edited in April of the same year."

Answered by AI
~13 spots leftby Jun 2025