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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)

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ClinicalTrials.gov Identifier: NCT02998528
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

December 16, 2016
December 20, 2016
January 7, 2019
January 13, 2017
April 8, 2020   (Final data collection date for primary outcome measure)
  • Event-Free Survival [ Time Frame: Up to 69 months ]
  • Pathological Complete Response [ Time Frame: At the time of surgery ]
Major Pathological Response (MPR) rate [ Time Frame: At time of surgery ]
Complete list of historical versions of study NCT02998528 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

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.

The first primary completion date of Pathological Complete Response is anticipated to be reached April 2020.

The completion date for all primary outcome measures is expected May 2023.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
326
November 8, 2028
April 8, 2020   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
Argentina,   Brazil,   Canada,   China,   France,   Greece,   Hungary,   Italy,   Japan,   Korea, Republic of,   Romania,   South Africa,   Spain,   Taiwan,   Turkey,   United States
 
 
NCT02998528
CA209-816
2016-003536-21 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
January 2019

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