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PD-L1 Inhibitor
Coformulated Pembrolizumab/Vibostolimab for Non-Small Cell Lung Cancer
Phase 3
Recruiting
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
Must not have
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~ 2 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with Stage IV non-small cell lung cancer (NSCLC) showing PD-L1 expression in at least 1% of tumor cells. Participants must not need EGFR-, ALK-, or ROS1-directed therapy, have a life expectancy of over 3 months, and an ECOG score of 0-1. Women must use effective contraception or be abstinent, and all participants should have adequate organ function.
What is being tested?
The study tests if a combination drug (pembrolizumab/vibostolimab) is more effective than pembrolizumab alone in improving survival without cancer progression. It focuses on patients whose tumors express the protein PD-L1 to varying degrees and measures overall survival and disease progression.
What are the potential side effects?
Potential side effects include allergic reactions to the drugs' components, immune system-related issues such as inflammation in various organs, fatigue, possible infections due to lowered immunity, and complications related to pre-existing conditions like pneumonitis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor shows PD-L1 expression in at least 1% of cells.
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My lung cancer is confirmed to be at stage IV.
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I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of Hepatitis B or an active Hepatitis C infection.
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I have had pneumonitis treated with steroids or have it now.
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I have been treated with a drug targeting the TIGIT pathway before.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I have had chemotherapy or targeted therapy for my advanced lung cancer.
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I am currently being treated for an infection.
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I have been treated with specific immune therapy drugs before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~ 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
OS in Participants With PD-L1 TPS 1% to 49%
OS in Participants With PD-L1 TPS ≥1%
Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%
+2 moreSecondary study objectives
Pain
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
+42 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab/VibostolimabExperimental Treatment1 Intervention
Participants will receive pembrolizumab/vibostolimab as a coformulation (MK-7684A).
Group II: PembrolizumabActive Control1 Intervention
Participants will receive pembrolizumab (MK-3475) alone.
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,112 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,975 Previous Clinical Trials
5,176,686 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,859 Previous Clinical Trials
8,080,883 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab/Vibostolimab
- Group 2: Pembrolizumab
Awards:
This trial has 2 awards, including:- 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.
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.
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