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)

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02998528
• Collaborator: Ono Pharmaceutical Co. Ltd (Industry)
• Enrollment: 505
• Locations: 136
• Arms: 3
• Anticipated Duration (Months): 140.2
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Mar 4, 2017
• Actual Primary Completion Date: Sep 8, 2021
• Anticipated Study Completion Date: Nov 8, 2028

Arms and Interventions

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

Primary Outcome Measures

1. Event-Free Survival (EFS) [Up to 69 months]

2. Pathological Complete Response (pCR) [At the time of surgery]

Secondary Outcome Measures

1. Overall survival (OS) [Up to approximately 193 months]

2. Major pathological response (MPR) [At time of surgery]

3. Time to Death or Distant Metastases (TTDM) [Up to 69 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Arizona Oncology Assoc, Pc-Hal	Glendale	Arizona	United States	85308
2	Los Angeles Hematology/Oncology Medical Group	Los Angeles	California	United States	90017
3	Rocky Mountain Cancer Center	Denver	Colorado	United States	80218
4	Cancer Center Of Central Connecticut	Plainville	Connecticut	United States	06062
5	Memorial Regional Hospital	Hollywood	Florida	United States	33201
6	University of Miami	Miami	Florida	United States	33136
7	Cancer Institute Of Florida	Orlando	Florida	United States	32804
8	Orlando Health, Inc.	Orlando	Florida	United States	32806
9	Indian River Medical Center	Vero Beach	Florida	United States	32960
10	Northwest Georgia Oncology Center, P.C.	Marietta	Georgia	United States	30060
11	Northwestern Medicine	Chicago	Illinois	United States	60611
12	University Of Chicago Medical Center	Chicago	Illinois	United States	60637
13	Illinois Cancer Specialists	Niles	Illinois	United States	60714
14	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana	United States	46804
15	University of Kentucky	Lexington	Kentucky	United States	40536
16	University Of Louisville	Louisville	Kentucky	United States	40202
17	University Medical Center New Orleans	New Orleans	Louisiana	United States	70112
18	Harry And Jeanette Weinberg Cancer Inst At Franklin Square	Baltimore	Maryland	United States	21237
19	Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins	Baltimore	Maryland	United States	21287
20	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
21	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
22	Southcoast Center For Cancer	Fairhaven	Massachusetts	United States	02719
23	Henry Ford Health System	Detroit	Michigan	United States	48202
24	Hattiesburg Clinic	Hattiesburg	Mississippi	United States	39401
25	St Vincent Frontier Cancer Center	Billings	Montana	United States	59102
26	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89128
27	The Cancer Center At Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
28	Valley Hospital Luckow Pavili	Westwood	New Jersey	United States	07675
29	New York Oncology Hematology, Pc	Albany	New York	United States	12208
30	Laura & Isaac Perlmutter Cancer Center	New York	New York	United States	10016
31	UNC Regional Physicians Hematology & Oncology	High Point	North Carolina	United States	27262
32	Christ Hospital	Cincinnati	Ohio	United States	45219
33	MetroHealth Medical Center	Cleveland	Ohio	United States	44109
34	Genesis Health Care System	Zanesville	Ohio	United States	43701
35	Kaiser Permanente	Portland	Oregon	United States	97227
36	Oregon Health & Science University	Portland	Oregon	United States	97239
37	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
38	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
39	Charleston Hematology Oncology Associates, Pa	Charleston	South Carolina	United States	29414
40	Medical University Of South Carolina	Charleston	South Carolina	United States	29425
41	Bon Secours-St Francis Hosp	Greenville	South Carolina	United States	29607
42	Tennessee Oncology, Pc	Nashville	Tennessee	United States	37203
43	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
44	Texas Oncology, PA - South Austin Cancer Center	Austin	Texas	United States	78745
45	Texas Oncology	Bedford	Texas	United States	76022
46	WBAMC Oncology Department	Fort Bliss	Texas	United States	79918
47	Millenium Oncology	Houston	Texas	United States	77090
48	Southwest Cancer Center	Lubbock	Texas	United States	79415
49	Texas Cancer Center - Sherman	Sherman	Texas	United States	75090-0504
50	HOPE Cancer Center of East Texas	Tyler	Texas	United States	75701
51	Texas Oncology	Waco	Texas	United States	76712
52	Intermountain Medical Center	Murray	Utah	United States	84107
53	Southwest Regional Cancer Clinic	Saint George	Utah	United States	84770
54	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
55	University of Vermont Cancer Center	Burlington	Vermont	United States	05405
56	Virginia Cancer Specialists, PC	Fairfax	Virginia	United States	22031
57	Hematology-Oncology Associates Of Fredricksburg, Inc	Fredericksburg	Virginia	United States	22408
58	Instituto Medico Especializado Alexander Fleming	Capital Federal	Buenos Aires	Argentina	1426
59	Hospital Italiano De Buenos Aires	Ciudad Autonoma De Buenos Aire	Buenos Aires	Argentina	1181
60	Hospital Sirio Libanes	Brasilia	Distrito Federal	Brazil	70200-730
61	PERSONAL Oncologia de Precisao e Personalizada	Belo Horizonte	Minas Gerais	Brazil	30130-090
62	ONCOSITE - Centro de Pesquisa Clinica em Oncologia	Ijui	RIO Grande DO SUL	Brazil	98700-000
63	Hospital Sao Lucas Da Pucrs	Porto Alegre	RIO Grande DO SUL	Brazil	90610-000
64	Fundacao Pio Xii Hosp Cancer De Barretos	Barretos	Sao Paulo	Brazil	14784-400
65	Instituto COI de Educacao e Pesquisa	Rio de Janeiro		Brazil	22793-080
66	CISSS de l'Outaouais	Gatineau	Quebec	Canada	J8P 7H2
67	Local Institution	Montreal	Quebec	Canada	H2X 0A9
68	Mcgill University Health Center	Montreal	Quebec	Canada	H4A 3J1
69	Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec	Trois-Rivieres	Quebec	Canada	G8Z 3R9
70	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada	S7N 4H4
71	Local Institution	Beijing	Beijing	China	100142
72	Local Institution	Beijing	Beijing	China	100730
73	Local Institution	Beijing	Beijing	China	100853
74	Local Institution	Guangzhou	Guangdong	China	510095
75	Local Institution	Changsha	Hunan	China	410008
76	Local Institution	Changsha	Hunan	China	410013
77	Local Institution	Nanchang	Jiangxi	China	330006
78	Local Institution	Changchun	Jilin	China	130012
79	Local Institution	Xi'an	Shan3xi	China	710038
80	Local Institution	Shanghai	Shanghai	China	200032
81	Local Institution	Chengdu	Sichuan	China	610041
82	Local Institution	Tianjin	Tianjin	China	300222
83	Local Institution	Hangzhou	Zhejiang	China	310003
84	Local Institution	Hangzhou	Zhejiang	China	310016
85	Local Institution	Hangzhou	Zhejiang	China	310022
86	Local Institution	Shanghai		China	200030
87	Local Institution	Xi'An		China
88	Local Institution	Marseille Cedex 20		France	13915
89	Local Institution	Paris		France	75005
90	Local Institution	Paris		France	75018
91	Local Institution	Pierre Benite		France	69495
92	Local Institution	Rennes Cedex 9		France	35033
93	Local Institution	Strasbourg		France	67100
94	Local Institution	Toulouse		France	31059
95	Local Institution	Tours Cedex		France	37044
96	Sotiria General Hospital	Athens		Greece	11527
97	Interbalkan European Medical Center	Thessaloniki		Greece	57001
98	Local Institution	Budapest		Hungary	1125
99	Local Institution	Szekesfehervar		Hungary	8000
100	Istituto Tumori Giovanni Paolo II	Bari		Italy	70124
101	Ospedale Policlinico San Martino	Genova		Italy	16132
102	Azienda Ospedaliera Di Perugia	Perugia		Italy	06132
103	Ospedale Santa Maria delle Croci	Ravenna		Italy	48100
104	Azienda Ospedaliera San Camillo Forlanini	Roma		Italy	00149
105	Local Institution	Nagoya	Aichi	Japan	4648681
106	Local Institution	Kashiwa-shi	Chiba	Japan	2778577
107	Local Institution	Kitakyushu-shi	Fukuoka	Japan	8078555
108	Local Institution	Fukushima-shi	Fukushima	Japan	9601295
109	Local Institution	Hiroshima-Shi	Hiroshima	Japan	7348551
110	Local Institution	Sapporo-shi	Hokkaido	Japan	0030804
111	Local Institution	Kobe-shi	Hyogo	Japan	6500047
112	Local Institution	Yokohama-shi	Kanagawa	Japan	2418515
113	Local Institution	Sendai-shi	Miyagi	Japan	9800873
114	Local Institution	Osaka-sayama-shi	Osaka	Japan	5898511
115	Local Institution	Osaka-shi	Osaka	Japan	5418567
116	Local Institution	Sakai-shi	Osaka	Japan	5918555
117	Local Institution	Sunto-gun	Shizuoka	Japan	4118777
118	Local Institution	Bunkyo-ku	Tokyo	Japan	1138431
119	Local Institution	Shinjuku-ku	Tokyo	Japan	1600023
120	Local Institution	Tokyo		Japan	1138603
121	Local Institution	Busan		Korea, Republic of	49267
122	Local Institution	Hwasun-gun		Korea, Republic of	58128
123	Local Institution	Seoul		Korea, Republic of	08308
124	Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha	Bucharest		Romania	020122
125	Sf. Nectarie Oncology Center	Craiova		Romania	200347
126	Prof. Dr. Ion Chiricuta Institute Of Oncology Day Care Dep	Romania		Romania	400015
127	H. Univ. Vall dHebron	Barcelona		Spain	08035
128	Hosp Univer 12 De Octubre	Madrid		Spain	28041
129	Hosp. Univ. Puerta De Hierro	Majadahonda - Madrid		Spain	28222
130	Local Institution	Taichung		Taiwan	40705
131	Local Institution	Taipei		Taiwan	11031
132	Local Institution	Taipei		Taiwan	11217
133	Local Institution	Taipei		Taiwan	235
134	Local Institution	Adana		Turkey	01060
135	Local Institution	Ankara		Turkey	06100
136	Local Institution	Istanbul		Turkey	34098

Sponsors and Collaborators

• Bristol-Myers Squibb
• Ono Pharmaceutical Co. Ltd

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02998528
• Other Study ID Numbers: CA209-816; 2016-003536-21
• First Posted: Dec 20, 2016
• Last Update Posted: Mar 15, 2022
• Last Verified: Feb 1, 2022

• 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; Gemcitabine; Paclitaxel; Vinorelbine; Docetaxel; Carboplatin; Nivolumab; Pemetrexed; Ipilimumab

Study Results

No Results Posted as of Mar 15, 2022