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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)

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ClinicalTrials.gov Identifier: NCT02659059
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE January 15, 2016
First Posted Date  ICMJE January 20, 2016
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE February 10, 2016
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
  • Objective response rate (ORR) [ Time Frame: Up to 6 months after the last subject first treatment ]
    Part 1 - nivolumab + ipilimumab In all treated PD-L1 positive (≥ 1%)
  • ORR [ Time Frame: Up to 6 months after the last subject first treatment ]
    Part 1 - nivolumab + ipilimumab In all treated PD-L1 negative (< 1%)
  • Number of Patients with dose Limiting Toxicities (DLTs) [ Time Frame: 9 weeks after last subject first treatment ]
    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy To determine DLT
  • Number of Adverse Events (AEs) [ Time Frame: Up to 6 months after the last subject first treatment ]
    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy Safety and Tolerability
  • Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 6 months after the last subject first treatment ]
    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy Safety and Tolerability
  • Number of Deaths [ Time Frame: Up to 6 months after the last subject first treatment ]
    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy Safety and Tolerability
  • Number of Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 6 months after the last subject first treatment ]
    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy Safety and Tolerability
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
The objective response rate (ORR) [ Time Frame: 6 months after the last subject first treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
  • Progression free survival (PFS) [ Time Frame: 6 months after the last subject first treatment ]
    Part 1 - nivolumab + ipilimumab
  • Overall Response Rate (ORR) [ Time Frame: 6 months after the last subject first treatment ]
    Part 1 - nivolumab + ipilimumab
  • Overall Survival (OS) [ Time Frame: 14 months after the last subject first treatment ]
    Part 1 - nivolumab + ipilimumab
  • PFS [ Time Frame: 6 months after the last subject first treatment ]
    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy
  • ORR [ Time Frame: 6 months after the last subject first treatment ]
    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy
  • OS [ Time Frame: 6 months after the last subject first treatment ]
    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
  • Progression free survival (PFS) [ Time Frame: 6 months after the last subject first treatment ]
  • Progression free survival (PFS) at 6 months [ Time Frame: 6 months after the first dosing date ]
  • Duration of Response (DOR) [ Time Frame: 6 months after last patient first treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small-Cell Lung Cancer
Intervention  ICMJE
  • Biological: Nivolumab
    Specified Dose on Specified Days
    Other Names:
    • BMS-936558
    • Opdivo
  • Biological: Ipilimumab
    Specified Dose on Specified Days
    Other Names:
    • BMS-734016
    • Yervoy
  • Drug: Platinum Doublet Chemotherapy
    Carboplatin + Paclitaxel Cisplatin + pemetrexed
Study Arms  ICMJE
  • Experimental: Nivolumab+Ipilimumab

    Part 1

    Specified Dose on Specified Days

    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy

    Part 2

    Specified Dose on Specified Days

    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
    • Drug: Platinum Doublet Chemotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 31, 2019)
506
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2016)
170
Estimated Study Completion Date  ICMJE April 20, 2022
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries Argentina,   Chile,   France,   Germany,   Spain
 
Administrative Information
NCT Number  ICMJE NCT02659059
Other Study ID Numbers  ICMJE CA209-568
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP