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Pembrolizumab + Infliximab for Melanoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- 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.
- Group 1: Pembrolizumab + Infliximab
- Group 2: Pembrolizumab + Placebo
Frequently Asked Questions
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."
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."
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."
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."
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