Immunotherapy + Chemotherapy for Lung Cancer
(CheckMate 816 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.This study has multiple primary endpoints.
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for people with early-stage IB-IIIA operable non-small cell lung cancer (NSCLC) who have good lung function and can handle surgery. They should be relatively healthy, which means having an ECOG Performance Status of 0-1. Those with advanced inoperable or metastatic disease, autoimmune diseases, or previous treatments targeting T cell pathways cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either nivolumab plus ipilimumab, nivolumab plus platinum doublet chemotherapy, or platinum doublet chemotherapy alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Ipilimumab
- Nivolumab
- Paclitaxel
- Pemetrexed
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Ono Pharmaceutical Co. Ltd
Industry Sponsor
Shinji Takai
Ono Pharmaceutical Co. Ltd
Chief Medical Officer since 2023
MD from an unspecified institution
Gyo Sagara
Ono Pharmaceutical Co. Ltd
Chief Executive Officer since 2024
PhD in Pharmaceutical Sciences from Kyoto University