CheckMate 9DW: A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04039607

Collaborator

(none)

728

Enrollment

254

Locations

Arms

63.2

Anticipated Duration (Months)

2.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Nivolumab Drug: Ipilimumab Drug: Sorafenib Drug: lenvatinib	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

728 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

Actual Study Start Date :

Sep 30, 2019

Anticipated Primary Completion Date :

May 6, 2024

Anticipated Study Completion Date :

Jan 4, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nivolumab + Ipilimumab	Drug: Nivolumab Participants will receive nivolumab as intravenous (IV) infusion. Drug: Ipilimumab Participants will receive ipilimumab as IV infusion.
Active Comparator: Sorafenib/lenvatinib	Drug: Sorafenib Participants will receive sorafenib as oral tablets. Drug: lenvatinib Participants will receive lenvatinib as oral capsules.

Arm

Intervention/Treatment

Experimental: Nivolumab + Ipilimumab

Drug: Nivolumab

Participants will receive nivolumab as intravenous (IV) infusion.

Drug: Ipilimumab

Participants will receive ipilimumab as IV infusion.

Active Comparator: Sorafenib/lenvatinib

Drug: Sorafenib

Participants will receive sorafenib as oral tablets.

Drug: lenvatinib

Participants will receive lenvatinib as oral capsules.

Outcome Measures

Primary Outcome Measures

Overall Survival (OS) [Up to 4 years]

Secondary Outcome Measures

Objective Response Rate (ORR) [Up to 4 years]
Duration of Response (DOR) [Up to 4 years]
Time to Symptom Deterioration (TTSD) [Up to 4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants must have a diagnosis of HCC based on histological confirmation
Participants must have an advanced HCC
Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
Child-Pugh score 5 or 6
Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1

Exclusion Criteria:

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Prior liver transplant
Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization
Active brain metastases or leptomeningeal metastases

Other protocol-defined inclusion/exclusion criteria apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Birmingham	Alabama	United States	35233
2	Local Institution - 0292	Tucson	Arizona	United States	85719
3	Local Institution - 0288	Coronado	California	United States	92118
4	Local Institution - 0157	Duarte	California	United States	91010-3012
5	Local Institution	Orange	California	United States	92868
6	Local Institution	Palo Alto	California	United States	94304
7	Local Institution - 0077	Washington	District of Columbia	United States	20007
8	Local Institution	Tampa	Florida	United States	33612
9	Local Institution	Iowa City	Iowa	United States	52242
10	Local Institution	Louisville	Kentucky	United States	40202
11	Local Institution - 0027	Louisville	Kentucky	United States	40217
12	Local Institution - 0190	Baltimore	Maryland	United States	21287
13	Local Institution	Baltimore	Maryland	United States	21287
14	Local Institution	Ann Arbor	Michigan	United States	48105
15	Local Institution - 0018	Detroit	Michigan	United States	48202
16	Local Institution	Duluth	Minnesota	United States	55802-2207
17	Local Institution	Minneapolis	Minnesota	United States	55455
18	Local Institution - 0295	Newark	New Jersey	United States	07103
19	Local Institution	New York	New York	United States	10029-6542
20	Local Institution	New York	New York	United States	10032
21	Local Institution	Rochester	New York	United States	14642
22	Local Institution	Williamsville	New York	United States	14221
23	Local Institution	Cleveland	Ohio	United States	44106
24	Local Institution - 0043	Toledo	Ohio	United States	43623
25	Local Institution	Hershey	Pennsylvania	United States	17033
26	Allegheny General Hospital AGH - Allegheny Cancer Center	Pittsburgh	Pennsylvania	United States	15212
27	Local Institution	Pittsburgh	Pennsylvania	United States	15232
28	Local Institution - 0304	Dallas	Texas	United States	75203
29	Local Institution - 0202	Houston	Texas	United States	77030
30	Local Institution - 0046	Lubbock	Texas	United States	79410
31	Local Institution - 0172	Salt Lake City	Utah	United States	84106
32	Local Institution	Charlottesville	Virginia	United States	22903
33	Local Institution	Seattle	Washington	United States	98104
34	Local Institution	Madison	Wisconsin	United States	53792
35	Local Institution - 0136	Caba	Buenos Aires	Argentina	1426
36	Local Institution - 0037	Caba	Buenos Aires	Argentina	C1090AAS
37	Local Institution - 0194	Pilar	Buenos Aires	Argentina	B1629AHJ
38	Local Institution - 0282	Rosario	Santa FE	Argentina	2000
39	Local Institution - 0058	Tucuman		Argentina	4000
40	Local Institution - 0003	Kogarah	New South Wales	Australia	2217
41	Local Institution - 0038	Liverpool	New South Wales	Australia	1871
42	Local Institution - 0002	Westmead	New South Wales	Australia	2145
43	Local Institution - 0004	Birtinya	Queensland	Australia	4560
44	Local Institution - 0013	Herston	Queensland	Australia	4029
45	Local Institution - 0009	Adelaide	South Australia	Australia	5000
46	Local Institution - 0019	Clayton	Victoria	Australia	3168
47	Local Institution - 0026	Fitzroy	Victoria	Australia	3065
48	Local Institution - 0001	Melbourne	Victoria	Australia	3004
49	Local Institution - 0020	St Albans	Victoria	Australia	3021
50	Local Institution - 0057	Wiener Neustadt	Niederosterreich	Austria	2700
51	Local Institution - 0188	Graz		Austria	8036
52	Local Institution	Graz		Austria	8036
53	Local Institution	Innsbruck		Austria	6020
54	Local Institution - 0065	Klagenfurt		Austria	9020
55	Local Institution - 0114	St. Polten		Austria	3100
56	Local Institution - 0186	Viena		Austria	1090
57	Local Institution - 0298	Gent		Belgium	9000
58	Local Institution	Gent		Belgium	9000
59	Local Institution - 0099	Haine-Saint-Paul		Belgium	7100
60	Local Institution - 0034	Leuven		Belgium	3000
61	Local Institution - 0064	Leuven		Belgium	3000
62	Local Institution - 0104	Liege		Belgium	4000
63	Local Institution	Salvador	Bahia	Brazil	41253190
64	Local Institution - 0061	Salvador	Bahia	Brazil	41950-640
65	Local Institution	Fortaleza	Ceara	Brazil	60135-237
66	Local Institution - 0181	Brasilia	DF	Brazil	70200-730
67	Local Institution - 0008	Brasilia	Distrito Federal	Brazil	70297-400
68	Local Institution - 0278	Vitoria	Espirito Santo	Brazil	29055-450
69	Local Institution - 0016	Curitiba	Parana	Brazil	81520060
70	Local Institution - 0279	Ijui	RIO Grande DO SUL	Brazil	98700-000
71	Local Institution - 0060	Pelotas	RIO Grande DO SUL	Brazil	960400-10
72	Local Institution	Porto Alegre	RIO Grande DO SUL	Brazil	91350-200
73	Local Institution - 0054	Jau	SAO Paulo	Brazil	17210-120
74	Local Institution - 0280	Sao Jose do Rio Preto	SAO Paulo	Brazil	15090-000
75	Local Institution	Rio de Janeiro		Brazil	20230-130
76	Local Institution - 0015	Rio de Janeiro		Brazil	22793-080
77	Local Institution - 0023	Sao Paulo		Brazil	01246-000
78	Local Institution - 0022	Sao Paulo		Brazil	01323-001
79	Local Institution - 0050	Sao Paulo		Brazil	04038-034
80	Local Institution - 0192	Edmonton	Alberta	Canada	T6G 1Z2
81	Local Institution	Montreal	Quebec	Canada	H2X 3E4
82	Local Institution	Montreal	Quebec	Canada	H3T 1E2
83	Local Institution - 0296	Temuco	Araucania	Chile	4780000
84	Local Institution - 0094	La Serena	Coquimbo	Chile	1720430
85	Local Institution - 0024	Santiago	Metropolitana	Chile	7620002
86	Local Institution - 0156	Santiago	Metropolitana	Chile	8380456
87	Local Institution - 0095	Santiago	Metropolitana	Chile	8420383
88	Local Institution - 0283	Santiago	RM	Chile	7630372
89	Centro de Investigaciones Clinicas Vina del Mar	Vina del Mar	Valparaiso	Chile	2540488
90	Local Institution - 0012	Viña del Mar	Valparaiso	Chile	2520598
91	Local Institution - 0120	Hefei Shi	Anhui	China	230022
92	Local Institution - 0146	Hefei	Anhui	China	230601
93	Local Institution - 0170	Beijing	Beijing	China	100000
94	Local Institution - 0175	Beijing	Beijing	China	100089
95	Local Institution - 0152	Beijing	Beijing	China	100853
96	Local Institution - 0121	Fuzhou City	Fujian	China	350014
97	Local Institution - 0151	Fuzhou	Fujian	China	350025
98	Local Institution - 0125	Guangzhou	Guangdong	China	510000
99	Local Institution - 0150	Guangzhou	Guangdong	China	510515
100	Local Institution - 0135	Harbin	Heilongjiang	China	150081
101	Local Institution - 0059	Changsha	Hunan	China	410011
102	Local Institution - 0109	Changsha	Hunan	China	410013
103	Local Institution - 0130	Nanjing	Jiangsu	China	210002
104	Local Institution - 0145	Nanchang	Jiangxi	China	330006
105	Local Institution - 0149	Nanchang	Jiangxi	China	330019
106	Local Institution - 0166	Changchun	Jilin	China	130012
107	Local Institution - 0162	Changchun	Jilin	China	130021
108	Local Institution - 0131	Dalian	Liaoning	China	116023
109	Local Institution - 0123	Shenyang	Liaoning	China	110004
110	Local Institution - 0132	Shenyang	Liaoning	China	110117
111	Local Institution - 0147	Xian	Shaanxi	China	710061
112	Local Institution - 0133	Xian	Shan3xi	China	710038
113	Local Institution - 0153	Qingdao	Shandong	China	266000
114	Local Institution - 0134	Shanghai	Shanghai	China	201321
115	Local Institution - 0179	Chongqing	Sichuan	China	400030
116	Local Institution - 0108	Hangzhou	Zhejiang	China	310016
117	Local Institution - 0107	Hangzhou	Zhejiang	China	310022
118	Local Institution - 0307	Xi'an		China	710126
119	Local Institution - 0274	Praha	Prague	Czechia	14059
120	Local Institution	Brno		Czechia	60200
121	Local Institution - 0068	Amiens		France	80054
122	Local Institution - 0116	Caen		France	14033
123	Local Institution - 0069	Clichy		France	92110
124	Local Institution - 0138	Dijon		France	21000
125	Local Institution - 0081	Grenoble Cedex 9		France	38043
126	Local Institution - 0070	Lyon		France	69004
127	Local Institution	Marseille		France	13009
128	Local Institution - 0082	Montpellier		France	34295
129	Local Institution - 0067	Nice		France	6202
130	Local Institution - 0025	Pessac		France	33604
131	Local Institution - 0137	Poitiers		France	86021
132	Local Institution	Reims		France	51092
133	Local Institution	Rennes		France	35042
134	Local Institution - 0042	Toulouse Cedex 9		France	31059
135	Local Institution - 0071	Vandoeuvre les Nancy		France	54500
136	Local Institution - 0051	Villejuif		France	94800
137	Local Institution - 0005	Frankfurt	Hessen	Germany	60590
138	Local Institution	Berlin		Germany	13353
139	Local Institution - 0231	Bonn		Germany	53127
140	Local Institution - 0052	Essen		Germany	45147
141	Local Institution	Freiburg I. Breisgau		Germany	79106
142	Local Institution - 0185	Freiburg		Germany	79106
143	Local Institution - 0006	Hamburg		Germany	20246
144	Local Institution - 0102	Hannover		Germany	30625
145	Local Institution - 0028	Koeln		Germany	50937
146	Local Institution - 0118	Leipzig		Germany	04103
147	Local Institution	Magdeburg		Germany	39120
148	Local Institution - 0031	Mainz		Germany	55131
149	Local Institution - 0056	Mannheim		Germany	68167
150	Local Institution	Munchen		Germany	81675
151	Local Institution	Munich		Germany	81377
152	Local Institution - 0053	North Rhine-Westphalia		Germany	45136
153	Local Institution	Wurzburg		Germany	97078
154	Local Institution - 0032	Hong Kong		Hong Kong	0
155	Local Institution - 0036	Hong Kong		Hong Kong	999077
156	Local Institution - 0110	Meldola	Forli-Cesena	Italy	47014
157	Local Institution - 0101	Rozzano	Milano	Italy	20089
158	Local Institution - 0039	Milano	MI	Italy	20122
159	Local Institution	Bergamo		Italy	24127
160	Local Institution - 0084	Candiolo		Italy	10060
161	Local Institution	Milano		Italy	20133
162	Local Institution - 0100	Novara		Italy	28100
163	Local Institution - 0219	Padova		Italy	35128
164	Local Institution - 0033	Parma		Italy	43126
165	Local Institution - 0112	Roma		Italy	00128
166	Local Institution	Roma		Italy	00128
167	Local Institution - 0079	Rome		Italy	00168
168	Local Institution - 0111	Siena		Italy	53100
169	Local Institution - 0044	Vicenza		Italy	36100
170	Local Institution - 0204	Chiba-shi	Chiba	Japan	2608677
171	Local Institution - 0193	Kashiwa-shi	Chiba	Japan	2778577
172	Local Institution - 0203	Matsuyama	Ehime	Japan	790-0024
173	Local Institution - 0155	Sapporo	Hokkaido	Japan	060-0033
174	Local Institution - 0176	Kanazawa	Ishikawa	Japan	920-8641
175	Local Institution - 0200	Yokohama-Shi	Kanagawa	Japan	232-0024
176	Local Institution - 0262	Yokohama	Kanagawa	Japan	241-8515
177	Local Institution - 0189	Kyoto-shi	Kyoto	Japan	602-8566
178	Local Institution	Kyoto-shi	Kyoto	Japan	602-8566
179	Local Institution - 0261	Kashihara City	Nara	Japan	634-8522
180	Local Institution - 0263	Abeno-ku	Osaka	Japan	5458586
181	Local Institution - 0127	Osakasayama	Osaka	Japan	589-8511
182	Local Institution - 0281	Saga Shi	Saga	Japan	8408571
183	Local Institution - 0259	Izunokuni-shi	Shizuoka	Japan	4102295
184	Local Institution - 0128	Minato-ku	Tokyo	Japan	1058470
185	Local Institution - 0201	Mitaka	Tokyo	Japan	181-8611
186	Local Institution - 0199	Musashino-shi	Tokyo	Japan	180-8610
187	Local Institution - 0178	Fukuoka		Japan	830-0011
188	Local Institution - 0177	Hiroshima		Japan	7348851
189	Local Institution - 0122	Kanagawa		Japan	213-8587
190	Local Institution - 0258	Saitama		Japan	350-0495
191	Local Institution - 0097	Goyang-si	Gyeonggi-do	Korea, Republic of	10408
192	Local Institution - 0062	Jongno-gu	Seoul	Korea, Republic of	03080
193	Local Institution - 0142	Busan		Korea, Republic of	49241
194	Local Institution - 0098	Gyeongsangnam-do		Korea, Republic of	050612
195	Local Institution - 0143	Seongnam-si		Korea, Republic of	13496
196	Local Institution - 0141	Seoul		Korea, Republic of	03722
197	Local Institution - 0140	Seoul		Korea, Republic of	05505
198	Local Institution - 0139	Seoul		Korea, Republic of	06351
199	Local Institution - 0167	Seoul		Korea, Republic of	08308
200	Local Institution - 0047	Auckland		New Zealand	1142
201	Local Institution - 0148	Gdansk		Poland	80-219
202	Local Institution - 0049	Otwock		Poland	05-400
203	Local Institution - 0092	Warszawa		Poland	02-034
204	Local Institution - 0289	Rio Piedras		Puerto Rico	00927
205	Local Institution - 0035	San Juan		Puerto Rico	927
206	Local Institution - 0164	Bucharest		Romania	022328
207	Local Institution - 0165	Cluj Napoca		Romania	400015
208	Local Institution - 0103	Craiova		Romania	200347
209	Local Institution	Craiova		Romania	200385
210	Local Institution - 0163	Timisoara		Romania	300166
211	Local Institution - 0029	Arkhangelsk		Russian Federation	163045
212	Local Institution - 0066	Barnaul		Russian Federation	656045
213	Local Institution - 0074	Chelyabinsk		Russian Federation	454087
214	Local Institution	Krasnoyarsk		Russian Federation	660133
215	Local Institution - 0007	Moscow		Russian Federation	115478
216	Local Institution - 0072	Pyatigorsk		Russian Federation	357502
217	Local Institution - 0075	Saint-Petersburg		Russian Federation	197758
218	Local Institution - 0091	Saint-Petersburg		Russian Federation	198255
219	Local Institution - 0073	Sochi		Russian Federation	354057
220	Local Institution - 0048	Singapore		Singapore	169610
221	Local Institution - 0017	Singapore		Singapore	258499
222	Local Institution - 0174	Singapore		Singapore	308442
223	Local Institution - 0297	Barcelona		Spain	08035
224	Local Institution - 0055	Barcelona		Spain	08036
225	Local Institution - 0089	Barcelona		Spain	08908
226	Local Institution - 0090	Cordoba		Spain	14004
227	Local Institution - 0087	El Palmar		Spain	30120
228	Local Institution - 0041	Madrid		Spain	28007
229	Local Institution - 0093	Madrid		Spain	28028
230	Local Institution - 0290	Madrid		Spain	28034
231	Local Institution	Madrid		Spain	28040
232	Local Institution - 0045	Majadahonda		Spain	28222
233	Local Institution - 0085	Pamplona		Spain	31008
234	Local Institution - 0088	Santander		Spain	39008
235	Local Institution	Valladolid		Spain	47012
236	Local Institution - 0040	Zaragoza		Spain	50009
237	Local Institution - 0063	Bern		Switzerland	3010
238	Local Institution	Zuerich		Switzerland	8091
239	Local Institution	Zurich		Switzerland	8091
240	Local Institution - 0272	Kaohsiung		Taiwan	807
241	Local Institution - 0096	Kaohsiung		Taiwan	83301
242	Local Institution - 0105	Taichung		Taiwan	40447
243	Local Institution - 0271	Taichung		Taiwan	40705
244	Local Institution - 0168	Tainan		Taiwan	704
245	Local Institution - 0270	Tainan		Taiwan	736
246	Local Institution - 0144	Taipei		Taiwan	100
247	Local Institution - 0173	Taoyuan		Taiwan	333
248	Local Institution - 0078	Tapei		Taiwan	11217
249	Local Institution - 0171	London	Greater London	United Kingdom	W12 OHS
250	Local Institution - 0154	Guildford	Surrey	United Kingdom	GU2 7XX
251	Local Institution	Bristol		United Kingdom	BS2 8ED
252	Local Institution - 0286	Christchurch		United Kingdom	BH23 2JX
253	Local Institution - 0160	Edinburgh		United Kingdom	EH4 2XU
254	Local Institution - 0129	London		United Kingdom	SE5 9RS