Pembrolizumab Combination Therapy for Non-Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with boserolimab (MK-5890), MK-4830, MK-0482 in participants with advanced squamous or non-squamous NSCLC that have been previously treated with anti-PD-L1 therapy. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on chronic systemic steroid therapy or any form of immunosuppressive therapy, you may need to stop these at least 7 days before starting the trial.
What data supports the effectiveness of the drug Pembrolizumab for non-small cell lung cancer?
Is pembrolizumab generally safe for humans?
Pembrolizumab has been associated with some immune-related side effects, such as type 1 diabetes in 0.2% of cases and pneumonitis in 1%-5% of patients. Common side effects include fatigue, cough, nausea, and rash, but the benefits in treating serious conditions like cancer often outweigh these risks.34678
What makes the pembrolizumab combination therapy unique for non-small cell lung cancer?
This treatment is unique because it combines pembrolizumab, a drug that helps the immune system fight cancer by blocking a pathway that tumors use to hide, with other investigational drugs like Boserolimab, MK-0482, MK-4830, and MK-5890, potentially enhancing its effectiveness against non-small cell lung cancer.12349
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab in combination with investigational agents (boserolimab, MK-4830, or MK-0482) every 3 weeks for up to 35 cycles (approximately 2 years)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for adverse events and progression-free survival
Treatment Details
Interventions
- Boserolimab
- MK-0482
- MK-4830
- MK-5890
- Pembrolizumab
Boserolimab is already approved in European Union, United States, Canada, Japan for the following indications:
- Melanoma
- Non-small cell lung cancer
- Head and neck cancer
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Endometrial carcinoma
- Melanoma
- Non-small cell lung cancer
- Head and neck cancer
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Endometrial carcinoma
- Esophageal carcinoma
- Cervical cancer
- Melanoma
- Non-small cell lung cancer
- Head and neck cancer
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Endometrial carcinoma
- Melanoma
- Non-small cell lung cancer
- Head and neck cancer
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University