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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a histologically- or cytologically-confirmed diagnosis of Stage IV squamous or non-squamous NSCLC.
Have progressive disease (PD) during/after platinum doublet chemotherapy
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to approximately 27 months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is looking at the efficacy and safety of two different drugs in combination with pembrolizumab for people with NSCLC who have been treated with anti-PD-L1 therapy before.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have already received treatment with a certain type of medication called an anti-PD-(L)1 monoclonal antibody, either by itself or with other similar medications, but your condition did not improve.
Select...
You have a specific type of lung cancer called non-squamous NSCLC and you cannot receive a targeted therapy that is already approved for your condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 27 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Secondary outcome measures
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experience One or More Adverse Events (AEs)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Pembrolizumab + MK-4830Experimental Treatment2 Interventions
On Day 1 of each 3-week cycle, participants receive pembrolizumab 200 mg intravenously (IV) PLUS MK-4830 IV for a maximum of 35 cycles (approximately 2 years).
Group II: Pembrolizumab + MK-0482Experimental Treatment2 Interventions
On Day 1 of each 3-week cycle, participants receive pembrolizumab 200 mg intravenously (IV) PLUS MK-0482 IV for a maximum of 35 cycles (approximately 2 years).
Group III: Pembrolizumab + BoserolimabExperimental Treatment4 Interventions
On Day 1 of each 3-week cycle, participants receive pembrolizumab 200 mg intravenously (IV) PLUS boserolimab IV for a maximum of 35 cycles (approximately 2 years). All participants are premedicated 1.5 hours (±30 minutes) before infusion of boserolimab with 50 mg oral (PO) diphenhydramine (or equivalent dose of antihistamine) and 500-1000 mg of acetaminophen PO (or equivalent dose of analgesic).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2030
diphenhydramine
2011
Completed Phase 4
~400
acetaminophen
2008
Completed Phase 4
~2870
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,828 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,822 Previous Clinical Trials
5,014,643 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,732 Previous Clinical Trials
8,016,869 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have cancer that has spread to your brain or the lining of your brain.You have had lung inflammation in the past that needed steroids to treat, or you currently have lung inflammation.You have a specific type of lung cancer called non-squamous NSCLC and you cannot receive a targeted therapy that is already approved for your condition.You have another type of cancer that has been getting worse or needed treatment in the past 2 years.You have a condition where your immune system attacks your own body and you have needed strong medication to treat it in the last 2 years.You have received a transplant of someone else's tissue or organ.You have already received treatment with a certain type of medication called an anti-PD-(L)1 monoclonal antibody, either by itself or with other similar medications, but your condition did not improve.You have had a serious allergic reaction to monoclonal antibodies, like pembrolizumab, or any of the substances used in them.You have mental health or substance abuse issues that may make it difficult for you to follow the study's instructions.You have had radiation therapy to the lung with a high dose within the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Boserolimab
- Group 2: Pembrolizumab + MK-4830
- Group 3: Pembrolizumab + MK-0482
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other medical research has been conducted with Pembrolizumab?
"Pembrolizumab was first studied in 2004 at the Clinical Addictions Research Laboratory. Since then, there have been 1010 completed trials and 1114 active studies recruiting patients. Many of these are based in Lexington, Kentucky."
Answered by AI
Are investigators still looking for new participants for this experiment?
"No, this study is not currently enrolling patients. The trial was initially posted on January 21st, 2020 and the most recent edit was made on October 31st, 2022. There are 2508 other trials that may be recruiting at this time."
Answered by AI
Could you tell me how many different hospitals are testing this new medication?
"There are 18 clinical trial sites running this particular study, including the University of Kentucky Markey Cancer Center (Site 0019) in Lexington, Laura and Isaac Perlmutter Cancer Center at NYU Langone Health (Site 0034) in New York, and University of California San Francisco (Site 0007) in Washingtonf Californ in New York, and University of California San Francisco (Site 0007) in Washington. Other locations include:"
Answered by AI
What are some conditions that Pembrolizumab has been shown to be effective for?
"Pembrolizumab is an effective treatment for unresectable melanoma, microsatellite instability high, and catarrh."
Answered by AI
Has Pembrolizumab been cleared by the FDA?
"Pembrolizumab falls into the category of a Phase 2 trial medication, so there is some evidence backing its safety. However, because it is still in clinical trials there is no data to support its efficacy."
Answered by AI
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