Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
CheckMate 568
A Study of Nivolumab in Combination With Ipilimumab (Part 1); and Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)
1 other identifier
interventional
324
2 countries
32
Brief Summary
The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy. The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2016
Longer than P75 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2016
CompletedFirst Posted
Study publicly available on registry
January 20, 2016
CompletedStudy Start
First participant enrolled
February 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2018
CompletedResults Posted
Study results publicly available
July 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2022
CompletedApril 5, 2023
March 1, 2023
2.4 years
January 15, 2016
June 10, 2021
March 7, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1
Objective response rate (ORR) in PD-L1 positive (PD-L1 ≥1%) and PD-L1 negative (PD-L1 \<1%) participants was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.
From first dose to database lock (Up to 18 months)
Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2
Dose limiting toxicities (DLTs) were defined as any of the items listed below. 1. Any Grade 2 drug-related uveitis or eye pain that does not respond to topical therapy and does not improve to Grade 1 severity within the re-treatment period OR requires systemic treatment. 2. Any Grade 2 drug-related pneumonitis or interstitial lung disease that does not resolve to dose delay and systemic steroids in 14 days. 3. Any Grade 3 non-skin drug-related adverse event with the exception of laboratory abnormalities that cannot be alleviated or controlled by appropriate care within 14 days. 4. Any Grade 4 drug-related adverse event including laboratory abnormalities except Grade 4 leukopenia or neutropenia lasting \< 14 days and asymptomatic amylase/lipase elevation. 5. Drug-related hepatic function laboratory abnormalities.
9 weeks after first dose
Number of Participants With Adverse Events (AEs) - Part 2
Number of participants with adverse events (AEs) including serious adverse events (SAEs) and deaths graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy.
Deaths are from first dose to database lock (Up to 24 months). AEs and SAEs are from first dose to 30 days post last dose
Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2
Number of participant with specific liver laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy.
From first dose to 30 days post last dose
Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2
Number of participants with specific thyroid laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy.
From first dose to 30 days post last dose
Secondary Outcomes (12)
Overall Survival (OS) - Part 1
From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)
Overall Survival (OS) - Part 2
From the date of first treatment to the date of death due to any cause (Up to approximately 59 months)
Progression Free Survival (PFS) - Part 1
From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)
Progression Free Survival (PFS) - Part 2
From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 59 months)
Objective Response Rate (ORR) - Part 1
From first dose up to approximately 72 months
- +7 more secondary outcomes
Study Arms (2)
Nivolumab+Ipilimumab
EXPERIMENTALPart 1 Specified Dose on Specified Days
Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy
EXPERIMENTALPart 2 Specified Dose on Specified Days
Interventions
Specified Dose on Specified Days
Specified Dose on Specified Days
Eligibility Criteria
You may qualify if:
- Men and Women ≥ 18 years of age
- Diagnosed with stage IV Non-Small Cell Lung Cancer
- Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options.
You may not qualify if:
- Subjects with untreated CNS metastases are excluded.
- Subjects with carcinomatous meningitis
- Subjects with an active, known or suspected autoimmune disease.
- Subjects with a condition requiring systemic treatment with either corticosteroids ( \> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.
- Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Sharp Memorial Hospital
San Diego, California, 92123, United States
Cancer Center Of Central Connecticut
Plainville, Connecticut, 06062, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Winship Cancer Institute.
Atlanta, Georgia, 30322, United States
Summit Cancer Care
Savannah, Georgia, 31405, United States
Cancer Center Of Kansas
Wichita, Kansas, 67214, United States
University Of Louisville Medical Center, Inc., Dba
Louisville, Kentucky, 40202, United States
Johns Hopkins Cancer Center
Baltimore, Maryland, 21287, United States
Local Institution - 0029
Boston, Massachusetts, 02114-2621, United States
Local Institution - 0030
Boston, Massachusetts, 02114-2621, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Local Institution - 0015
Lincoln, Nebraska, 68506, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Local Institution - 0036
Albuquerque, New Mexico, 87106, United States
Lovelace Cancer Care
Albuquerque, New Mexico, 87131, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87131, United States
New Mexico Cancer Care Center
Albuquerque, New Mexico, 87131, United States
The Cancer Center at Presbyterian
Albuquerque, New Mexico, 87131, United States
Local Institution - 0010
Mineola, New York, 11501, United States
Memorial Sloan Kettering Nassau
New York, New York, 10065, United States
Duke University
Durham, North Carolina, 27710, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2412, United States
Local Institution - 0006
Pittsburgh, Pennsylvania, 15212, United States
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, 29414, United States
Tennessee Oncology, PLLC - SCRI - PPDS
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6307, United States
Local Institution - 0022
Kingston, Ontario, K7L 2V7, Canada
Local Institution - 0023
Sault Ste. Marie, Ontario, P6B 0A8, Canada
Csss De St-Jerome
Saint-Jérôme, Quebec, J7Z 5T3, Canada
Related Publications (1)
Ready N, Hellmann MD, Awad MM, Otterson GA, Gutierrez M, Gainor JF, Borghaei H, Jolivet J, Horn L, Mates M, Brahmer J, Rabinowitz I, Reddy PS, Chesney J, Orcutt J, Spigel DR, Reck M, O'Byrne KJ, Paz-Ares L, Hu W, Zerba K, Li X, Lestini B, Geese WJ, Szustakowski JD, Green G, Chang H, Ramalingam SS. First-Line Nivolumab Plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer (CheckMate 568): Outcomes by Programmed Death Ligand 1 and Tumor Mutational Burden as Biomarkers. J Clin Oncol. 2019 Apr 20;37(12):992-1000. doi: 10.1200/JCO.18.01042. Epub 2019 Feb 20.
PMID: 30785829DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2016
First Posted
January 20, 2016
Study Start
February 15, 2016
Primary Completion
June 22, 2018
Study Completion
March 7, 2022
Last Updated
April 5, 2023
Results First Posted
July 22, 2021
Record last verified: 2023-03