Non-Small-Cell Lung CancerPhase 2CheckMate 568NCT02659059
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
A Phase 2 study testing Nivolumab, Ipilimumab and Platinum Doublet Chemotherapy in people with Non-Small-Cell Lung Cancer, run by Bristol-Myers Squibb at 32 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- Nivolumab, Ipilimumab and Platinum Doublet Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 15 Feb 2016to 7 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States29 sites
Local Institution - 0036
Albuquerque, New Mexico, 87106
Lovelace Cancer Care
Albuquerque, New Mexico, 87131
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87131
New Mexico Cancer Care Center
Albuquerque, New Mexico, 87131
The Cancer Center at Presbyterian
Albuquerque, New Mexico, 87131
Winship Cancer Institute.
Atlanta, Georgia, 30322
Johns Hopkins Cancer Center
Baltimore, Maryland, 21287
Local Institution - 0029
Boston, Massachusetts, 02114-2621
Local Institution - 0030
Boston, Massachusetts, 02114-2621
Massachusetts General Hospital
Boston, Massachusetts, 02114
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, 29414
The Ohio State University
Columbus, Ohio, 43210
Henry Ford Health System
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Local Institution - 0015
Lincoln, Nebraska, 68506
University Of Louisville Medical Center, Inc., Dba
Louisville, Kentucky, 40202
Local Institution - 0010
Mineola, New York, 11501
Tennessee Oncology, PLLC - SCRI - PPDS
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6307
Memorial Sloan Kettering Nassau
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2412
Local Institution - 0006
Pittsburgh, Pennsylvania, 15212
Cancer Center Of Central Connecticut
Plainville, Connecticut, 06062
Sharp Memorial Hospital
San Diego, California, 92123
Summit Cancer Care
Savannah, Georgia, 31405
Cleveland Clinic Florida
Weston, Florida, 33331
Cancer Center Of Kansas
Wichita, Kansas, 67214
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103
Canada3 sites
Local Institution - 0022
Kingston, Ontario, K7L 2V7
Csss De St-Jerome
Saint-Jérôme, Quebec, J7Z 5T3
Local Institution - 0023
Sault Ste. Marie, Ontario, P6B 0A8
About this study
Official title: 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)
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.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Nivolumab, Ipilimumab, Platinum Doublet Chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called BMS-936558, Opdivo
Specified Dose on Specified Days
IpilimumabBiological
Also called BMS-734016, Yervoy
Specified Dose on Specified Days
Platinum Doublet ChemotherapyDrug
Also called Carboplatin + Paclitaxel, Cisplatin + pemetrexed
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab+Ipilimumab | Experimental | Part 1
Specified Dose on Specified Days Receives: Biological: Nivolumab; Biological: Ipilimumab |
| Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy | Experimental | Part 2
Specified Dose on Specified Days Receives: Biological: Nivolumab; Biological: Ipilimumab; Drug: Platinum Doublet Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
- 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.
- Any Grade 2 drug-related pneumonitis or interstitial lung disease that does not resolve to dose delay and systemic steroids in 14 days.
- 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.
- Any Grade 4 drug-related adverse event including laboratory abnormalities except Grade 4 leukopenia or neutropenia lasting < 14 days and asymptomatic amylase/lipase elevation.
- Drug-related hepatic function laboratory abnormalities.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first dose to 30 days post last dose
Secondary outcomes (12)
Overall Survival (OS) - Part 1
Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.
Measured: 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
Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.
Measured: 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
Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Measured: 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
Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by investigator (per RECIST 1.1), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Measured: 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
Objective response rate (ORR) 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.
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose up to approximately 72 months
Objective Response Rate (ORR) - Part 2
Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment.
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose up to approximately 59 months
Overall Survival (OS) by PD-L1 Expression Levels - Part 1
Overall survival (OS) by PD-L1 expression levels was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.
PD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 <1% = PD-L1 negative (membranous staining in <1% tumor cells)
Measured: From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)
Progression Free Survival (PFS) by PD-L1 Expression Levels - Part 1
Progression Free Survival (PFS) by PD-L1 expression levels was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
PD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 <1% = PD-L1 negative (membranous staining in <1% tumor cells)
Measured: From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)
Objective Response Rate (ORR) by PD-L1 Expression Levels-Part 1
Objective response rate (ORR) by PD-L1 expression levels 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.
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
PD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 <1% = PD-L1 negative (membranous staining in <1% tumor cells)
Measured: From first dose up to approximately 72 months
Overall Survival (OS) by Tumor Mutation Burden (TMB) Levels - Part 1
Overall survival (OS) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.
High TMB = ≥ 10 mutations per megabase Low TMB = < 10 mutations per megabase
Measured: From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)
Progression Free Survival (PFS) by Tumor Mutation Burden (TMB) Levels - Part 1
Progression Free Survival (PFS) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
High TMB = ≥ 10 mutations per megabase Low TMB = < 10 mutations per megabase
Measured: From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)
Objective Response Rate (ORR) by Tumor Mutation Burden (TMB) Levels - Part 1
Objective response rate (ORR) by tumor mutational burden (TMB) using DNA derived from tumor specimens 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.
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
High TMB = ≥ 10 mutations per megabase Low TMB = < 10 mutations per megabase
Measured: From first dose up to approximately 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study start15 Feb 2016
- Primary completion22 Jun 2018
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659059
- Sponsor's protocol ID
- CA209-568
- Acronym
- CheckMate 568
- Status last verified
- Mar 2023
- First submitted
- 15 Jan 2016
- Last updated
- 5 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 30785829
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02659059
- Acronym / sponsor ID
- CheckMate 568 / CA209-568
- Conditions
- Non-Small-Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Posted 22 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab+Ipilimumab | Experimental | Biological: Nivolumab, Biological: IpilimumabPart 1 Specified Dose on Specified Days |
| Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy | Experimental | Biological: Nivolumab, Biological: Ipilimumab, Drug: Platinum Doublet ChemotherapyPart 2 Specified Dose on Specified Days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: BMS-936558, OpdivoSpecified Dose on Specified Days | Biological | Nivolumab+Ipilimumab, Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy |
| IpilimumabAlso: BMS-734016, YervoySpecified Dose on Specified Days | Biological | Nivolumab+Ipilimumab, Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy |
| Platinum Doublet ChemotherapyAlso: Carboplatin + Paclitaxel, Cisplatin + pemetrexed | Drug | Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy |
Primary outcome
Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1
Time frame: From first dose to database lock (Up to 18 months)
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.
Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2
Time frame: 9 weeks after first dose
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.
Number of Participants With Adverse Events (AEs) - Part 2
Time frame: 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 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.
Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2
Time frame: From first dose to 30 days post last dose
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.
Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2
Time frame: From first dose to 30 days post last dose
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.
12 secondary outcomes
Overall Survival (OS) - Part 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From first dose up to approximately 72 months
Objective Response Rate (ORR) - Part 2
Time frame: From first dose up to approximately 59 months
Overall Survival (OS) by PD-L1 Expression Levels - Part 1
Time frame: From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)
Progression Free Survival (PFS) by PD-L1 Expression Levels - Part 1
Time frame: From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)
Objective Response Rate (ORR) by PD-L1 Expression Levels-Part 1
Time frame: From first dose up to approximately 72 months
Overall Survival (OS) by Tumor Mutation Burden (TMB) Levels - Part 1
Time frame: From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)
Progression Free Survival (PFS) by Tumor Mutation Burden (TMB) Levels - Part 1
Time frame: From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)
Objective Response Rate (ORR) by Tumor Mutation Burden (TMB) Levels - Part 1
Time frame: From first dose up to approximately 72 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30785829Ready 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.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
Related trials for Non-Small-Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Ipilimumab and Platinum Doublet Chemotherapy in people with Non-Small-Cell Lung Cancer, run by Bristol-Myers Squibb at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1 (time frame: From first dose to database lock (Up to 18 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02659059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.