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Pembrolizumab + Epigenetic Drugs for Lung Cancer
Study Summary
This trial is testing the safety of combining three drugs to treat cancer. Pembrolizumab will be given at a set dose, while guadecitabine and mocetinostat will be given at different doses to test their efficacy and side effects.
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.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- I am currently on medication for an infection.You have a history of autoimmune disease.I do not have another cancer that is getting worse or needs treatment now.You have a positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV), indicating an ongoing infection.My cancer tissue sample was taken through a core biopsy.My lung cancer is at stage IIIb or IV.I have had pneumonitis treated with steroids or have it now.I have recovered from side effects of my previous cancer treatment.I have not been treated with platinum-based chemotherapy and my condition is not expected to worsen significantly within the next 12 weeks.I haven't had radiation therapy outside the brain within a week before starting the study treatment.I have been diagnosed with tuberculosis in the past.I am able and willing to sign the consent form.I stopped a PD-1/PD-L1 therapy due to an immune-related side effect.I have brain metastases that have not been treated.I have not had a stroke or mini-stroke in the last 6 months.I have a heart condition.I have had lung conditions that needed steroid treatment.I haven't taken immunosuppressive drugs in the last 7 days.I am 18 years old or older.My blood, kidney, and liver functions are within normal ranges.My cancer has specific changes in the EGFR gene or ALK rearrangements.My condition worsened despite treatment with anti-PD1/PD-L1 drugs.I am willing to have a biopsy before and during treatment.Your condition can be measured using a specific set of guidelines called RECIST v1.1.You have tested positive for HIV antibodies and/or RNA.I have not received a live vaccine in the last 30 days.I haven't had any cancer treatments in the last 3 weeks.I have been diagnosed with an immune system disorder.You have had an organ transplant from someone else.I am fully active or can carry out light work.Women who could become pregnant must have a negative pregnancy test within 28 days before starting the study.You are using reliable birth control.
- Group 1: pembrolizumab plus guadecitabine and mocetinostat
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
When was Pembrolizumab cleared by the FDA?
"Pembrolizumab received a score of 1 because, at this stage in development, there is only minimal data supporting both its efficacy and safety."
What is the most popular disease that Pembrolizumab is used to fight?
"Pembrolizumab is most often used to fight cancerous growths. Additionally, it has shown to be effective in treating unresectable melanoma, microsatellite instability high, and chemotherapy-resistant disease progression."
What is the target number of people that will be participating in this clinical trial?
"This study is no longer recruiting patients for participation. It was initially posted on 8/4/2017, with the last update on 10/28/2022. However, there are 1667 other trials for patients with lung cancer and 1008 for Pembrolizumab that are actively recruiting patients."
What other investigations have been made into Pembrolizumab?
"City of Hope was the first to study pembrolizumab in 2010 and, since then, there have been 275 completed trials. There are currently 1008 active trials being conducted, a fair few of which are based in Baltimore, Maryland."
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