A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator’s Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) ( CheckMate 8HW )
Program Status
Active, not recruitingPhase
Phase 3Prior Immunotherapy Allowed
NoCRC-directed Trial
YesDrugs
Bevacizumab, cetuximab, fluorouracil, Irinotecan, Leucovorin, oxaliplatinTags
MSI-H/ MMRdComments
Trial with many locations, worldwide (only a few still recruiting) to compare nivolumab in combination with ipilimumab with nivolumab monotherapy in patients with MSI-H/MMRd metastatic colorectal cancer. The study also compares nivolumab plus ipilimumab combination vs chemotherapy.
| Location | Location Status |
|---|---|
| United States | |
|
Local Institution - 0059 Los Angeles, California 90033 |
Active, not recruiting |
|
Local Institution - 0130 Sacramento, California 95817 |
Active, not recruiting |
|
Local Institution - 0103 Denver, Colorado 80218 |
Active, not recruiting |
|
Local Institution - 0119 Arlington Heights, Illinois 60005 |
Active, not recruiting |
|
Local Institution - 0060 New York, New York 10065 |
Active, not recruiting |
|
Local Institution - 0105 Portland, Oregon 97227 |
Active, not recruiting |
|
Local Institution - 0121 Pittsburgh, Pennsylvania 15232 |
Active, not recruiting |
|
Local Institution - 0106 Dallas, Texas 75246 |
Active, not recruiting |
|
Local Institution - 0104 Roanoke, Virginia 24014 |
Active, not recruiting |
| Argentina | |
|
Local Institution - 0073 Ciudad Autonoma Beunos Aires, Buenos Aires 1431 |
Active, not recruiting |
|
Local Institution - 0074 Viedma, RIO Negro 8500 |
Active, not recruiting |
|
Local Institution - 0084 Buenos Aires 1093 |
Active, not recruiting |
|
Local Institution - 0100 Caba 1199 |
Active, not recruiting |
|
Local Institution - 0072 Caba 1426 |
Active, not recruiting |
| Australia | |
|
Local Institution - 0019 Westmead, New South Wales 2145 |
Active, not recruiting |
|
Local Institution - 0053 Woolloongabba, Queensland 4102 |
Active, not recruiting |
|
Local Institution - 0018 Elizabeth Vale, South Australia 5112 |
Active, not recruiting |
|
Local Institution - 0041 Clayton, Victoria 3168 |
Active, not recruiting |
|
Local Institution - 0017 Heidelberg, Victoria 3084 |
Active, not recruiting |
| Austria | |
|
Local Institution - 0064 Graz 8036 |
Active, not recruiting |
|
Local Institution - 0068 Linz 4010 |
Active, not recruiting |
|
Local Institution - 0120 Salzburg 5020 |
Active, not recruiting |
|
Local Institution - 0067 Wiener Neustadt 2700 |
Active, not recruiting |
|
Local Institution - 0065 Wien 1090 |
Active, not recruiting |
| Belgium | |
|
Local Institution - 0045 Bonheiden, Antwerpen 2820 |
Active, not recruiting |
|
Local Institution - 0025 Anderlecht, Bruxelles-Capitale, Région De 1070 |
Active, not recruiting |
|
Local Institution - 0024 Leuven 3000 |
Active, not recruiting |
| Brazil | |
|
Local Institution - 0096 Ipatinga, Minas Gerais 35160-158 |
Active, not recruiting |
|
Local Institution - 0200 Natal, RIO Grande DO Norte 59075-740 |
Active, not recruiting |
|
Local Institution - 0192 Porto Alegre, RIO Grande DO SUL 91350-200 |
Active, not recruiting |
|
Local Institution - 0102 Barretos, Sao Paulo 14780-070 |
Active, not recruiting |
|
Local Institution - 0095 Sao Paulo, São Paulo 01509-010 |
Active, not recruiting |
|
Local Institution - 0094 São José do Rio Preto, São Paulo 15090000 |
Active, not recruiting |
|
Local Institution - 0199 Rio de Janeiro 20231-050 |
Active, not recruiting |
|
Local Institution - 0193 São Paulo 01246-000 |
Active, not recruiting |
| Canada | |
|
Local Institution - 0011 Edmonton, Alberta T6G 1Z2 |
Active, not recruiting |
|
Local Institution - 0039 Vancouver, British Columbia V5Z 4E6 |
Active, not recruiting |
|
Local Institution - 0013 Toronto, Ontario M5G 1X5 |
Active, not recruiting |
|
Local Institution - 0016 Montreal, Quebec H2X 3E4 |
Active, not recruiting |
|
Local Institution - 0015 Sherbrooke, Quebec J1H 5N4 |
Active, not recruiting |
| Chile | |
|
Local Institution - 0071 Santiago, Metropolitana 7500921 |
Active, not recruiting |
|
Local Institution - 0069 Santiago, Metropolitana 8320000 |
Active, not recruiting |
|
Local Institution - 0070 Independencia, Santiago |
Active, not recruiting |
| China | |
|
Local Institution - 0146 Hefei, Anhui 230061 |
Active, not recruiting |
|
Local Institution Fuzhou, Fujian 350001 |
Active, not recruiting |
|
Local Institution - 0163 Xiamen, Fujian 361003 |
Active, not recruiting |
|
Local Institution - 0207 Zhangzhou, Fujian 363000 |
Active, not recruiting |
|
Local Institution - 0211 Lanzhou, Gansu 730030 |
Active, not recruiting |
|
Local Institution - 0158 Foshan, Guangdong 528000 |
Active, not recruiting |
|
Local Institution - 0167 Guangzhou, Guangdong 510080 |
Active, not recruiting |
|
Local Institution - 0153 Guangzhou, Guangdong 510095 |
Active, not recruiting |
|
Local Institution - 0149 Guangzhou, Guangdong 510655 |
Active, not recruiting |
|
Local Institution - 0160 Nanning, Guangxi 530000 |
Active, not recruiting |
|
Local Institution - 0196 Nanning, Guangxi 530021 |
Active, not recruiting |
|
Local Institution - 0180 Harbin, Heilongjiang 150040 |
Active, not recruiting |
|
Local Institution - 0181 Zhengzhou, Henan 450052 |
Active, not recruiting |
|
Local Institution - 0197 Changsha, Hunan 410013 |
Active, not recruiting |
|
Local Institution - 0145 Changzhou, Jiangsu 213003 |
Active, not recruiting |
|
Local Institution - 0151 Nanchang, Jiangxi 330006 |
Active, not recruiting |
|
Local Institution - 0164 Changchun, Jilin 130021 |
Active, not recruiting |
|
Local Institution - 0162 Shenyang, Liaoning 110042 |
Active, not recruiting |
|
Local Institution - 0188 Xi'an, Shaanxi 710126 |
Active, not recruiting |
|
Local Institution - 0210 Jinan, Shandong 250117 |
Active, not recruiting |
|
Local Institution - 0212 Linyi, Shandong 276001 |
Active, not recruiting |
|
Local Institution - 0154 Qingdao, Shandong 266061 |
Active, not recruiting |
|
Local Institution - 0165 Yantai, Shandong 264000 |
Active, not recruiting |
|
Local Institution - 0143 Shanghai, Shanghai 200080 |
Active, not recruiting |
|
Local Institution - 0131 Shanghai, Shanghai 200120 |
Active, not recruiting |
|
Local Institution - 0221 Shanghai, Shanghai 200131 |
Active, not recruiting |
|
Local Institution - 0195 Kunming, Yunnan 650106 |
Active, not recruiting |
|
Local Institution - 0137 Hangzhou, Zhejiang 310009 |
Active, not recruiting |
|
Local Institution - 0206 Ningbo, Zhejiang 315041 |
Active, not recruiting |
| Czechia | |
|
Local Institution - 0087 Brno 656 53 |
Active, not recruiting |
|
Local Institution - 0085 Hradec Kralove 500 05 |
Active, not recruiting |
|
Local Institution - 0088 Novy Jicin 741 01 |
Active, not recruiting |
|
Local Institution - 0086 Olomouc 779 00 |
Active, not recruiting |
| Denmark | |
|
Local Institution - 0038 Herlev 2730 |
Active, not recruiting |
|
Local Institution - 0036 Vejle 7100 |
Active, not recruiting |
| France | |
|
Local Institution - 0176 Limoges, Haute-Vienne 87042 |
Active, not recruiting |
|
Local Institution - 0138 Lille, Nord 59000 |
Active, not recruiting |
|
Local Institution - 0186 Bayonne 64109 |
Active, not recruiting |
|
Local Institution - 0028 Besancon Cedex 25030 |
Active, not recruiting |
|
Local Institution - 0029 Lyon Cedex 08 69373 |
Active, not recruiting |
|
Local Institution - 0183 Lyon 69008 |
Active, not recruiting |
|
Local Institution - 0066 Marseille 13005 |
Active, not recruiting |
|
Local Institution - 0030 Montpellier 34298 |
Active, not recruiting |
|
Local Institution - 0032 Nantes 44093 |
Active, not recruiting |
|
Local Institution - 0027 Paris 75012 |
Active, not recruiting |
|
Local Institution - 0061 Pessac Cedex 33604 |
Active, not recruiting |
|
Local Institution - 0031 Poitiers 86000 |
Active, not recruiting |
|
Local Institution - 0184 Strasbourg 67200 |
Active, not recruiting |
|
Local Institution - 0040 Toulouse 31059 |
Active, not recruiting |
| Germany | |
|
Local Institution - 0042 Dresden 01307 |
Active, not recruiting |
|
Local Institution - 0007 Essen 45122 |
Active, not recruiting |
|
Local Institution - 0043 Hamburg 20249 |
Active, not recruiting |
|
Local Institution - 0117 Hamburg 22763 |
Active, not recruiting |
|
Local Institution - 0008 Hannover 30625 |
Active, not recruiting |
|
Local Institution - 0009 Heidelberg 69120 |
Active, not recruiting |
|
Local Institution - 0044 Marburg 35043 |
Active, not recruiting |
|
Local Institution - 0010 Munich 81377 |
Active, not recruiting |
| Greece | |
|
Local Institution - 0222 Athens 11525 |
Active, not recruiting |
|
Local Institution - 0123 Athens 11528 |
Active, not recruiting |
|
Local Institution - 0125 Heraklion 71110 |
Active, not recruiting |
|
Local Institution - 0124 Holargos 15562 |
Active, not recruiting |
|
Local Institution - 0126 Ioannina 45500 |
Active, not recruiting |
| Ireland | |
|
Local Institution - 0091 Dublin 8, Dublin |
Active, not recruiting |
|
Local Institution - 0022 Dublin |
Active, not recruiting |
|
Local Institution - 0026 Limerick V94 F858 |
Active, not recruiting |
| Italy | |
|
Local Institution - 0055 Catania 95122 |
Active, not recruiting |
|
Local Institution - 0003 Genova 16132 |
Active, not recruiting |
|
Local Institution - 0001 Milan 20162 |
Active, not recruiting |
|
Local Institution - 0004 Napoli 80131 |
Active, not recruiting |
|
Local Institution - 0002 Padova 35128 |
Active, not recruiting |
|
Local Institution - 0054 Roma 00168 |
Active, not recruiting |
| Japan | |
|
Local Institution - 0109 Nagoya-shi, Aichi 4648681 |
Active, not recruiting |
|
Local Institution - 0112 Chiba-shi, Chiba 260-8717 |
Active, not recruiting |
|
Local Institution - 0107 Kashiwa-shi, Chiba 2778577 |
Active, not recruiting |
|
Local Institution - 0132 Matsuyama, Ehime 791-0280 |
Active, not recruiting |
|
Local Institution - 0116 Fukuoka-shi, Fukuoka 8111395 |
Active, not recruiting |
|
Local Institution - 0174 Sapporo-shi, Hokkaido 0608648 |
Active, not recruiting |
|
Local Institution - 0128 Kanazawa-city, Ishikawa 9208641 |
Active, not recruiting |
|
Local Institution - 0111 Kawasaki, Kanagawa 216-8511 |
Active, not recruiting |
|
Local Institution - 0175 Yokohama, Kanagawa 241-8515 |
Active, not recruiting |
|
Local Institution - 0133 Kumamoto-shi, Kumamoto 8608556 |
Active, not recruiting |
|
Local Institution - 0189 Osaki, Miyagi 9896183 |
Active, not recruiting |
|
Local Institution - 0177 Kurashiki, Okayama 7108602 |
Active, not recruiting |
|
Local Institution - 0115 Suita-shi, Osaka 565-0871 |
Active, not recruiting |
|
Local Institution - 0187 Hidaka, Saitama 350-1298 |
Active, not recruiting |
|
Local Institution - 0110 Kitaadachigun, Saitama 362-0806 |
Active, not recruiting |
|
Local Institution - 0108 Sunto-gun, Shizuoka 4118777 |
Active, not recruiting |
|
Local Institution - 0118 Chuo-ku, Tokyo 1040045 |
Active, not recruiting |
|
Local Institution - 0113 Koto-ku, Tokyo 135-8550 |
Active, not recruiting |
|
Local Institution - 0129 Minato-ku, Tokyo 1058470 |
Active, not recruiting |
|
Local Institution - 0114 Osaka 540-0006 |
Active, not recruiting |
| Netherlands | |
|
Local Institution - 0052 Amsterdam, Noord-Holland 1066 CX |
Active, not recruiting |
|
Local Institution - 0051 Amsterdam, Noord-Holland 1081 HV |
Active, not recruiting |
|
Local Institution - 0050 Utrecht 3584 CX |
Active, not recruiting |
| Norway | |
|
Local Institution - 0033 Bergen 5021 |
Active, not recruiting |
|
Local Institution - 0034 Lorenskog 1478 |
Active, not recruiting |
|
Local Institution - 0035 Oslo 0450 |
Active, not recruiting |
| Puerto Rico | |
|
Local Institution - 0058 Rio Piedras 00935 |
Active, not recruiting |
| Romania | |
|
Local Institution - 0076 Cluj-Napoca, Cluj 400015 |
Active, not recruiting |
|
Local Institution - 0081 Craiova, Dolj 200542 |
Active, not recruiting |
|
Local Institution - 0168 Brasov 002200 |
Active, not recruiting |
|
Local Institution - 0080 Bucharest 022328 |
Active, not recruiting |
|
Local Institution - 0205 Iași 700483 |
Active, not recruiting |
|
Local Institution - 0089 Suceava 720237 |
Active, not recruiting |
| Spain | |
|
Local Institution - 0056 Badalona, Barcelona [Barcelona] 08916 |
Active, not recruiting |
|
Local Institution - 0173 A Coruna 15006 |
Active, not recruiting |
|
Local Institution - 0006 Barcelona 08035 |
Active, not recruiting |
|
Local Institution - 0005 Madrid 28041 |
Active, not recruiting |
|
Local Institution - 0172 Malaga 29010 |
Active, not recruiting |
|
Local Institution - 0063 Sevilla 41013 |
Active, not recruiting |
|
Local Institution - 0171 Valencia 46014 |
Active, not recruiting |
| Turkey | |
|
Local Institution - 0092 Adana 01060 |
Active, not recruiting |
|
Local Institution - 0101 Istanbul 34300 |
Active, not recruiting |
| United Kingdom | |
|
Local Institution - 0127 London EC1A 7BE |
Active, not recruiting |
|
Local Institution - 0049 Oxford OX3 7LE |
Active, not recruiting |
Inclusion Criteria
Inclusion Criteria:
* Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study)
* Histologically confirmed recurrent or metastatic CRC with no prior treatment history with chemotherapy and/or targeted agents for metastatic disease and not amenable to surgery (Applicable during Part 2 enrollment of the study)
* Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice
* Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1
Exclusion Criteria
Exclusion Criteria:
* An active, known or suspected autoimmune disease
* History of interstitial lung disease or pneumonitis
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Other protocol-defined inclusion/exclusion criteria apply
