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

Non Small Cell Lung Cancer Clinical Trial

— CheckMate 816  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02998528
• Other study ID #: CA209-816
• Secondary ID: 2016-003536-21
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 4, 2017
• Est. completion date: November 8, 2028

Study information

• Verified date: October 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 505
• Est. completion date: November 8, 2028
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Biological:
• Nivolumab
Specified dose on specified days

Drug:
• Cisplatin
Specified dose on specified days
• Vinorelbine
Specified dose on specified days
• Gemcitabine
Specified dose on specified days
• Docetaxel
Specified dose on specified days
• Pemetrexed
Specified dose on specified days
• Carboplatin
Specified dose on specified days
• Paclitaxel
Specified dose on specified days

Biological:
• Ipilimumab
This arm is closed and no longer enrolling patients.

Locations

Country	Name	City	State
Argentina	Local Institution - 0022	Capital Federal	Buenos Aires
Argentina	Local Institution - 0023	Ciudad Autonoma De Buenos Aire	Buenos Aires
Brazil	Fundacao Pio Xii Hosp Cancer De Barretos	Barretos	Sao Paulo
Brazil	Local Institution - 0077	Belo Horizonte	Minas Gerais
Brazil	Local Institution - 0079	Brasilia	Distrito Federal
Brazil	Local Institution - 0076	Ijui	RIO Grande DO SUL
Brazil	Local Institution - 0073	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0075	Rio de Janeiro
Canada	Local Institution - 0095	Gatineau	Quebec
Canada	Local Institution - 0017	Montreal	Quebec
Canada	Local Institution - 0138	Montreal	Quebec
Canada	Local Institution - 0016	Saskatoon	Saskatchewan
Canada	Local Institution - 0052	Trois-Rivieres	Quebec
China	Local Institution	Beijing	Beijing
China	Local Institution - 0156	Beijing	Beijing
China	Local Institution - 0161	Beijing	Beijing
China	Local Institution	Changchun	Jilin
China	Local Institution - 0175	Changsha	Hunan
China	Local Institution - 0192	Changsha	Hunan
China	Local Institution - 0193	Changsha	Hunan
China	Local Institution - 0178	Chengdu	Sichuan
China	Local Institution - 0190	Guangzhou	Guangdong
China	Local Institution - 0182	Hangzhou	Zhejiang
China	Local Institution - 0183	Hangzhou	Zhejiang
China	Local Institution - 0189	Hangzhou	Zhejiang
China	Local Institution - 0166	Nanchang	Jiangxi
China	Local Institution - 0179	Nanchang	Jiangxi
China	Local Institution - 0160	Shanghai	Shanghai
China	Local Institution - 0165	Shanghai
China	Local Institution - 0163	Tianjin	Tianjin
China	Local Institution - 0159	XiAn	Shan1xi
China	Local Institution - 0180	Xian	Shan3xi
France	Local Institution - 0059	Marseille Cedex 20
France	Local Institution - 0060	Paris
France	Local Institution - 0112	Paris Cedex 5
France	Local Institution - 0064	Pierre Benite
France	Local Institution - 0061	Rennes Cedex 9
France	Local Institution - 0113	Strasbourg
France	Local Institution - 0058	Toulouse
France	Local Institution - 0062	Tours Cedex 09
Greece	Local Institution - 0019	Athens
Greece	Local Institution - 0122	Thessaloniki
Hungary	Local Institution	Budapest
Hungary	Local Institution	Szekesfehervar
Italy	Local Institution - 0068	Bari
Italy	Local Institution - 0080	Genova
Italy	Local Institution - 0070	Perugia
Italy	Local Institution - 0066	Ravenna
Italy	Local Institution - 0067	Roma
Japan	Local Institution - 0126	Bunkyo-ku	Tokyo
Japan	Local Institution - 0110	Fukushima-shi	Fukushima
Japan	Local Institution - 0109	Hiroshima-Shi	Hiroshima
Japan	Local Institution - 0118	Kashiwa-shi	Chiba
Japan	Local Institution - 0111	Kitakyushu-shi	Fukuoka
Japan	Local Institution - 0133	Kobe-shi	Hyogo
Japan	Local Institution - 0131	Nagoya-shi	Aichi
Japan	Local Institution - 0108	Osaka-sayama-shi	Osaka
Japan	Local Institution - 0127	Osaka-shi	Osaka
Japan	Local Institution - 0119	Sakai-shi	Osaka
Japan	Local Institution - 0147	Sapporo-shi	Hokkaido
Japan	Local Institution - 0148	Sendai-shi	Miyagi
Japan	Local Institution - 0120	Shinjuku-ku	Tokyo
Japan	Local Institution - 0132	Sunto-gun	Shizuoka
Japan	Local Institution - 0124	Tokyo
Japan	Local Institution - 0123	Yokohama-shi	Kanagawa
Korea, Republic of	Local Institution - 0097	Busan
Korea, Republic of	Local Institution - 0098	Hwasun
Korea, Republic of	Local Institution - 0105	Seoul
Romania	Local Institution - 0050	Craiova
Romania	Local Institution - 0051	Romania
Romania	Local Institution - 0069	Sector 2
Spain	Local Institution - 0028	Barcelona
Spain	Local Institution - 0029	Madrid
Spain	Local Institution - 0031	Majadahonda - Madrid
Taiwan	Local Institution - 0102	New Taipei City
Taiwan	Local Institution - 0107	Taichung
Taiwan	Local Institution - 0099	Taipei
Taiwan	Local Institution - 0100	Taipei
Turkey	Local Institution - 0093	Adana
Turkey	Local Institution - 0084	Ankara
Turkey	Local Institution - 0115	Istanbul
United States	Local Institution - 0027	Albany	New York
United States	Local Institution - 0035	Austin	Texas
United States	Local Institution - 0001	Baltimore	Maryland
United States	Local Institution - 0151	Baltimore	Maryland
United States	Texas Oncology	Bedford	Texas
United States	St Vincent Frontier Cancer Center	Billings	Montana
United States	Local Institution - 0006	Boston	Massachusetts
United States	Local Institution - 0008	Boston	Massachusetts
United States	Local Institution - 0135	Burlington	Vermont
United States	Local Institution - 0013	Charleston	South Carolina
United States	Local Institution - 0021	Charleston	South Carolina
United States	Local Institution - 0002	Chicago	Illinois
United States	Local Institution - 0015	Chicago	Illinois
United States	Christ Hospital	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Local Institution - 0025	Denver	Colorado
United States	Local Institution - 0012	Detroit	Michigan
United States	Local Institution - 0125	Fairfax	Virginia
United States	Southcoast Center For Cancer	Fairhaven	Massachusetts
United States	Local Institution - 0153	Fort Bliss	Texas
United States	Local Institution - 0171	Fort Wayne	Indiana
United States	Local Institution - 0198	Fredericksburg	Virginia
United States	Local Institution - 0121	Glendale	Arizona
United States	Local Institution - 0146	Greenville	South Carolina
United States	Local Institution - 0009	Hackensack	New Jersey
United States	Local Institution - 0090	Hattiesburg	Mississippi
United States	Local Institution - 0140	High Point	North Carolina
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Local Institution - 0106	Houston	Texas
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Local Institution - 0170	Lexington	Kentucky
United States	Local Institution - 0081	Los Angeles	California
United States	Local Institution - 0186	Louisville	Kentucky
United States	Southwest Cancer Center	Lubbock	Texas
United States	Northwest Georgia Oncology Center, P.C.	Marietta	Georgia
United States	Local Institution - 0136	Miami	Florida
United States	Intermountain Medical Center	Murray	Utah
United States	Local Institution - 0005	Nashville	Tennessee
United States	Local Institution - 0092	Nashville	Tennessee
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	Local Institution - 0011	New York	New York
United States	Illinois Cancer Specialists	Niles	Illinois
United States	Cancer Institute Of Florida	Orlando	Florida
United States	Orlando Health, Inc.	Orlando	Florida
United States	Local Institution - 0010	Philadelphia	Pennsylvania
United States	Local Institution - 0018	Pittsburgh	Pennsylvania
United States	Local Institution - 0007	Plainville	Connecticut
United States	Kaiser Permanente	Portland	Oregon
United States	Local Institution - 0139	Portland	Oregon
United States	Southwest Regional Cancer Clinic	Saint George	Utah
United States	Local Institution - 0003	Salt Lake City	Utah
United States	Texas Cancer Center - Sherman	Sherman	Texas
United States	Local Institution - 0143	Tyler	Texas
United States	Indian River Medical Center	Vero Beach	Florida
United States	Local Institution - 0026	Waco	Texas
United States	Valley Hospital Luckow Pavili	Westwood	New Jersey
United States	Genesis Health Care System	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  China,  France,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Romania,  Spain,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-Free Survival (EFS)	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).	From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
Primary	Pathologic Complete Response (pCR) Rate	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).	From randomization up to a median of 30 months after randomization.
Secondary	Major Pathologic Response (MPR) Rate	Major pathologic response (MPR) rate is defined as number of randomized participants with	From randomization up to a median of 30 months after randomization.
Secondary	Overall Survival (OS)	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.	From randomization to the date of death
Secondary	Time to Death or Distant Metastases (TTDM)	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.	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)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls