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A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) (CheckMate 816)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02998528
Recruitment Status : Active, not recruiting
First Posted : December 20, 2016
Last Update Posted : July 24, 2020
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE December 16, 2016
First Posted Date  ICMJE December 20, 2016
Last Update Posted Date July 24, 2020
Actual Study Start Date  ICMJE January 13, 2017
Estimated Primary Completion Date May 8, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
  • Event-Free Survival (EFS) [ Time Frame: Up to 69 months ]
  • Pathological Complete Response (pCR) [ Time Frame: At the time of surgery ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
Major Pathological Response (MPR) rate [ Time Frame: At time of surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • Overall survival (OS) [ Time Frame: Up to approximately 193 months ]
  • Major pathological response (MPR) [ Time Frame: At time of surgery ]
  • Time to Death or Distant Metastases (TTDM) [ Time Frame: Up to 69 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • Event free survival (EFS) [ Time Frame: Up to approximately 130 months ]
  • Overall survival (OS) [ Time Frame: Up to approximately 130 months ]
  • Complete pathological response (pCR) [ Time Frame: At time of surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Official Title  ICMJE Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE
  • Biological: Nivolumab
    Other Names:
    • BMS-936558
    • Opdivo
  • Drug: Cisplatin
  • Drug: Vinorelbine
  • Drug: Gemcitabine
  • Drug: Docetaxel
  • Drug: Pemetrexed
  • Drug: Carboplatin
  • Drug: Paclitaxel
  • Biological: Ipilimumab
    This arm is closed and no longer enrolling patients.
    Other Names:
    • BMS-734016
    • Yervoy
Study Arms  ICMJE
  • Active Comparator: Platinum doublet chemotherapy
    Specified dose on specified days
    Interventions:
    • Drug: Cisplatin
    • Drug: Vinorelbine
    • Drug: Gemcitabine
    • Drug: Docetaxel
    • Drug: Pemetrexed
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: Nivolumab plus platinum doublet chemotherapy
    Specified dose on specified days
    Interventions:
    • Biological: Nivolumab
    • Drug: Cisplatin
    • Drug: Gemcitabine
    • Drug: Pemetrexed
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: Nivolumab plus Ipilimumab
    Specified dose on specified days
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: December 19, 2018)
350
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2016)
326
Estimated Study Completion Date  ICMJE November 8, 2028
Estimated Primary Completion Date May 8, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Inclusion Criteria:

  • Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
  • Lung function capacity capable of tolerating the proposed lung surgery
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Available tissue of primary lung tumor

Exclusion Criteria:

  • Presence of locally advanced, inoperable or metastatic disease
  • Participants with active, known or suspected autoimmune disease
  • Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

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 Argentina,   Brazil,   Canada,   China,   France,   Greece,   Hungary,   Italy,   Japan,   Korea, Republic of,   Romania,   Spain,   Taiwan,   Turkey,   United States
Removed Location Countries South Africa
 
Administrative Information
NCT Number  ICMJE NCT02998528
Other Study ID Numbers  ICMJE CA209-816
2016-003536-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date July 2020

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