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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
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 belowSelect...
I have not received any treatment yet and can be treated with pembrolizumab.
Select...
My melanoma is at Stage III or IV and cannot be removed by surgery.
Select...
I am 18 years old or older.
Select...
I have a tumor that can be measured with a scan.
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
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 moreTrial 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 Institute of TechnologyOTHER
97 Previous Clinical Trials
12,729,951 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,941 Previous Clinical Trials
13,200,632 Total Patients Enrolled
22 Trials studying Melanoma
1,063 Patients Enrolled for Melanoma
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to pembrolizumab or any of its ingredients.I have symptoms or untreated cancer spread to the lining of my brain and spinal cord.I had surgery for melanoma and now have Stage III or IV melanoma that cannot be removed with surgery.You had a bad reaction or were very sensitive to infliximab before.I am currently taking medication for cancer treatment.I have not received any treatment yet and can be treated with pembrolizumab.I am not on high-dose steroids or other drugs that weaken my immune system.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have had tuberculosis or similar infections.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.I have melanoma in my eyes or mucous membranes.I am currently being treated for a bacterial infection or have a systemic fungal infection.My melanoma is at Stage III or IV and cannot be removed by surgery.I am not pregnant or breastfeeding.I have been treated with specific immune therapies for my advanced cancer.I have a history of inflammatory bowel disease or related conditions.I have not received a live vaccine in the last 30 days.I experienced side effects from previous immunotherapy.I am 18 years old or older.I have a tumor that can be measured with a scan.I was treated with anti-PD-1 therapy over 6 months ago.I have been cancer-free for 3 years, except for certain skin cancers or cervical cancer in situ.I have a history of Hepatitis B or C but am cured if it was Hepatitis C.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Infliximab
- Group 2: Pembrolizumab + Placebo
Awards:
This trial has 0 awards, including: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
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
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