← Back to Search

Other

Pembrolizumab Combination Therapy for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
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
Male participants must agree to use contraception and refrain from donating sperm during the treatment period and for at least 120 days after the last dose of study treatment
Has a histologically- or cytologically-confirmed diagnosis of Stage IV squamous or non-squamous NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 27 months
Awards & highlights

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.

Who is the study for?
This trial is for adults with Stage IV NSCLC who have already tried anti-PD-L1 therapy and chemotherapy but their cancer has gotten worse. They must have good organ function, be able to provide a tumor tissue sample, not be pregnant or breastfeeding, agree to use contraception, and not have severe immune reactions from previous immunotherapies.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of pembrolizumab combined with other investigational drugs (boserolimab, MK-4830, MK-0482) in patients whose lung cancer has progressed after treatment with anti-PD-L1 therapy. It's part of a larger research project exploring different pembrolizumab combinations.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the medications used (like pembrolizumab), issues related to the immune system attacking normal cells in the body which can affect various organs, fatigue, fever or chills due to infusion reactions and potential liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a male and agree to use contraception and not donate sperm for 120 days after treatment.
Select...
My lung cancer is confirmed to be at stage IV.
Select...
My lung cancer is non-squamous and I can't have targeted therapy.
Select...
My organs are functioning well enough for treatment.
Select...
I am not pregnant or breastfeeding and either cannot become pregnant or will use contraception.
Select...
My cancer has worsened despite treatment with a specific immune therapy.
Select...
My cancer has worsened despite having platinum-based chemotherapy.
Select...
I can provide a recent or archived sample of my tumor for testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 27 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 27 months for reporting.

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)

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: Boserolimab + PembrolizumabExperimental 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 2
~1950
diphenhydramine
2011
Completed Phase 4
~420
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
4,581,776 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,049,565 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,062,065 Total Patients Enrolled

Media Library

Boserolimab (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04165096 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Boserolimab + Pembrolizumab, Pembrolizumab + MK-4830, Pembrolizumab + MK-0482
Non-Small Cell Lung Cancer Clinical Trial 2023: Boserolimab Highlights & Side Effects. Trial Name: NCT04165096 — Phase 2
Boserolimab (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04165096 — Phase 2

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 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
~88 spots leftby Feb 2032