Trial record 1 of 1 for:
checkmate 816
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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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 |
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Recruitment Status :
Active, not recruiting
First Posted : December 20, 2016
Last Update Posted : August 26, 2020
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Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 350 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 : | January 13, 2017 |
| Estimated Primary Completion Date : | May 8, 2023 |
| Estimated Study Completion Date : | November 8, 2028 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Platinum doublet chemotherapy
Specified dose on specified days
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Drug: Cisplatin Drug: Vinorelbine Drug: Gemcitabine Drug: Docetaxel Drug: Pemetrexed Drug: Carboplatin Drug: Paclitaxel |
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Experimental: Nivolumab plus platinum doublet chemotherapy
Specified dose on specified days
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Biological: Nivolumab
Other Names:
Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed Drug: Carboplatin Drug: Paclitaxel |
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Experimental: Nivolumab plus Ipilimumab
Specified dose on specified days
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Biological: Nivolumab
Other Names:
Biological: Ipilimumab This arm is closed and no longer enrolling patients.
Other Names:
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Primary Outcome Measures :
- Event-Free Survival (EFS) [ Time Frame: Up to 69 months ]
- Pathological Complete Response (pCR) [ 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 ]
- Time to Death or Distant Metastases (TTDM) [ Time Frame: Up to 69 months ]
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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
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
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
Show 137 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| 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 |
| Last Update Posted: | August 26, 2020 |
| Last Verified: | August 2020 |
| 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 Gemcitabine Paclitaxel Vinorelbine Docetaxel Carboplatin |
Nivolumab Pemetrexed Ipilimumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents |