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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)

This study is currently recruiting participants.
Verified October 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02998528
First Posted: December 20, 2016
Last Update Posted: October 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose

The purpose of this study is to determine the safety and effectiveness of nivolumab plus ipilimumab or nivolumab plus chemotherapy compared to chemotherapy alone in the treatment of Early Stage Non-Small Cell Lung

This study has multiple primary endpoints.

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

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


Condition Intervention Phase
Non Small Cell Lung Cancer Biological: Nivolumab Biological: ipilimumab Drug: cisplatin Drug: vinorelbine Drug: gemcitabine Drug: docetaxel Drug: pemetrexed Drug: carboplatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Event-Free Survival [ Time Frame: Up to 133 months ]
  • Pathological Complete Response [ Time Frame: At the time of surgery ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Up to approximately 193 months ]
  • Major pathological response (MPR) [ Time Frame: At time of surgery ]

Estimated Enrollment: 642
Actual Study Start Date: January 13, 2017
Estimated Study Completion Date: November 8, 2028
Estimated Primary Completion Date: May 8, 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab plus Ipilimumab
Specified dose on specified days
Biological: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
Biological: ipilimumab
Other Names:
  • BMS-734016
  • Yervoy
Active Comparator: Platinum doublet chemotherapy
Specified dose on specified days
Drug: cisplatin Drug: vinorelbine Drug: gemcitabine Drug: docetaxel Drug: pemetrexed Drug: carboplatin
Experimental: Nivolumab plus platinum doublet chemotherapy
Specified dose on specified days
Biological: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
Drug: cisplatin Drug: gemcitabine Drug: pemetrexed Drug: carboplatin

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998528


Contacts
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 #.

  Show 107 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02998528     History of Changes
Other Study ID Numbers: CA209-816
2016-003536-21 ( EudraCT Number )
First Submitted: December 16, 2016
First Posted: December 20, 2016
Last Update Posted: October 19, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Pemetrexed
Nivolumab
Vinorelbine
Carboplatin
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Phytogenic