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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
Results First Posted : September 28, 2022
Last Update Posted : October 16, 2023
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Biological: Nivolumab Drug: Cisplatin Drug: Vinorelbine Drug: Gemcitabine Drug: Docetaxel Drug: Pemetrexed Drug: Carboplatin Drug: Paclitaxel Biological: Ipilimumab Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 505 participants
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
Actual Study Start Date : March 4, 2017
Actual Primary Completion Date : September 8, 2021
Estimated Study Completion Date : November 8, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Platinum doublet chemotherapy
Specified dose on specified days
 Drug: Cisplatin
Specified dose on specified days

Drug: Vinorelbine
Specified dose on specified days

Drug: Gemcitabine
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days

Drug: Pemetrexed
Specified dose on specified days

Drug: Carboplatin
Specified dose on specified days

Drug: Paclitaxel
Specified dose on specified days
Experimental: Nivolumab plus platinum doublet chemotherapy
Specified dose on specified days
 Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Drug: Cisplatin
Specified dose on specified days

Drug: Gemcitabine
Specified dose on specified days

Drug: Pemetrexed
Specified dose on specified days

Drug: Carboplatin
Specified dose on specified days

Drug: Paclitaxel
Specified dose on specified days
Experimental: Nivolumab plus Ipilimumab
Specified dose on specified days
 Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
This arm is closed and no longer enrolling patients.
Other Names:
  • BMS-734016
  • Yervoy


Outcome Measures
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Primary Outcome Measures :
  1. Event-Free Survival (EFS) [ Time Frame: From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months) ]
    Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as 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. (Note: the appearance of one or more new lesions is also considered progression).

  2. Pathologic Complete Response (pCR) Rate [ Time Frame: From randomization up to a median of 30 months after randomization. ]
    Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).


Secondary Outcome Measures :
  1. Major Pathologic Response (MPR) Rate [ Time Frame: From randomization up to a median of 30 months after randomization. ]
    Major pathologic response (MPR) rate is defined as number of randomized participants with </= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.

  2. Overall Survival (OS) [ Time Frame: From randomization to the date of death ]
    Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive.

  3. Time to Death or Distant Metastases (TTDM) [ Time Frame: From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to a median of 30 months) ]
    TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.


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

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 apply

Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] August 18, 2021
Statistical Analysis Plan  [PDF] August 11, 2021

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02998528    
Other Study ID Numbers: CA209-816
2016-003536-21 ( EudraCT Number )
First Posted: December 20, 2016    Key Record Dates
Results First Posted: September 28, 2022
Last Update Posted: October 16, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Paclitaxel
Vinorelbine
Docetaxel
Carboplatin
Gemcitabine
 Nivolumab
Pemetrexed
Ipilimumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists