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Coformulated Pembrolizumab/Vibostolimab for Non-Small Cell Lung Cancer
Study Summary
This trial is testing whether a combination of two drugs is better than just one of the drugs for overall survival and progression-free survival in people with a certain kind of cancer.
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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- My tumor shows PD-L1 expression in at least 1% of cells.I have a history of Hepatitis B or an active Hepatitis C infection.You have a measurable disease according to specific medical guidelines.I have stable brain metastases and haven't needed steroids for 14 days.I have no health issues that prevent me from receiving standard lung cancer chemotherapy.My cancer is not suitable for EGFR, ALK, or ROS1 therapy.You are expected to live for at least 3 more months.I had another cancer but have been free of it for over 3 years after treatment.I had radiotherapy over 2 weeks ago, have no side effects, and didn't have radiation to the brain.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I am using or willing to use highly effective birth control or practice abstinence.I have had pneumonitis treated with steroids or have it now.You have been diagnosed with HIV in the past.My lung cancer is confirmed to be at stage IV.I have been treated with a drug targeting the TIGIT pathway before.My organs are functioning well.I have a history of lung scarring but my lung cancer has spread in a way that doesn't exclude me.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I am fully active or restricted in physically strenuous activity but can do light work.I have had chemotherapy or targeted therapy for my advanced lung cancer.I am currently being treated for an infection.I have been treated with specific immune therapy drugs before.I have not received a live vaccine within the last 30 days.I am not pregnant or breastfeeding.
- Group 1: Pembrolizumab/Vibostolimab
- Group 2: Pembrolizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are there any unfilled vacancies in this research project?
"As noted on clinicaltrials.gov, this study is still recruiting patients. The original posting was on April 7th, 2021, and the most recent update was on October 28th, 2022."
Are there any dangers that come with Pembrolizumab/Vibostolimab?
"Pembrolizumab/Vibostolimab falls into Phase 3 of clinical trials, which means that while there is safety data, there is also some evidence of efficacy."
Are Pembrolizumab/Vibostolimab part of a larger research project?
"Pembrolizumab/Vibostolimab was first studied a decade ago, in 2010, at City of Hope. To date, there are 248 completed trials and 999 trials that are still recruiting patients. A large number of these open trials are based in Mineola, New york."
At how many sites can participants take part in this clinical trial?
"This trial is being conducted at Perlmutter Cancer Center at NYU Langone Hospital - Long Island (Site 0022) in Mineola, New york, Lakeridge Health (Site 0106) in Oshawa, Ontario, Boca Raton Regional Hospital (Site 0004) in Boca Raton, Florida, and 11 other locations."
How many patients are taking part in this experiment?
"That is accurate. The clinicaltrials.gov website lists this study as currently recruiting, with the first posting on 4/7/2021 and the most recent edit on 10/28/2022. They are looking for 1246 participants at 11 sites."
For what purpose is the drug Pembrolizumab/Vibostolimab most often prescribed?
"Pembrolizumab/Vibostolimab is indicated for the treatment of cancerous neoplasms. However, it can also help patients with microsatellite instability high and disease progression after chemotherapy, in addition to those with unresectable melanoma."
What objectives has this clinical trial established?
"The primary goal of this medical study, which will take place over the course of ~51 months, is to track the Overall Survival (OS) of patients. Additionally, the study will measure the Duration of Response (DOR) for patients With PD-L1 TPS ≥50%. DOR is defined as the time from first documented evidence of Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, until progressive disease (PD)"
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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