Actively Recruiting
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
Led by AstraZeneca · Updated on 2026-03-17
1100
Participants Needed
168
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.
CONDITIONS
Official Title
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma and gallbladder carcinoma
- Unresectable locally advanced or metastatic biliary tract cancer, untreated in the advanced setting
- Known PD-L1 status assessed centrally using an acceptable tumor sample
- Measurable disease by RECIST 1.1 criteria using CT or MRI suitable for repeated measurements
- ECOG Performance Status of 0 or 1 with no deterioration over the previous 2 weeks before screening and randomization
- Adequate bone marrow and organ function
You will not qualify if you...
- Ampullary carcinoma
- Prior systemic therapy for unresectable, locally advanced or metastatic biliary tract cancer
- Prior exposure to therapies targeting immune-regulatory receptors or mechanisms
- Concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal cancer treatments other than study interventions
- Active or prior autoimmune or inflammatory disorders requiring chronic steroids or immunosuppressive treatment
- Active or ongoing interstitial lung disease or pneumonitis of any grade
- Serious chronic gastrointestinal conditions with diarrhea
- Active non-infectious skin diseases requiring systemic treatment such as rash, urticaria, dermatitis, ulceration, or psoriasis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 168 locations
1
Research Site
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
Research Site
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
3
Research Site
Tucson, Arizona, United States, 85719
Not Yet Recruiting
4
Research Site
Duarte, California, United States, 91010
Actively Recruiting
5
Research Site
Orange, California, United States, 92868
Not Yet Recruiting
6
Research Site
Santa Monica, California, United States, 90404
Not Yet Recruiting
7
Research Site
Stanford, California, United States, 94305-5847
Not Yet Recruiting
8
Research Site
Aurora, Colorado, United States, 80045
Not Yet Recruiting
9
Research Site
Hartford, Connecticut, United States, 06102
Not Yet Recruiting
10
Research Site
New Haven, Connecticut, United States, 06510
Not Yet Recruiting
11
Research Site
Washington D.C., District of Columbia, United States, 20007
Not Yet Recruiting
12
Research Site
Washington D.C., District of Columbia, United States, 20037
Not Yet Recruiting
13
Research Site
Jacksonville, Florida, United States, 32209
Not Yet Recruiting
14
Research Site
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
15
Research Site
Marietta, Georgia, United States, 30060
Actively Recruiting
16
Research Site
Chicago, Illinois, United States, 60612
Not Yet Recruiting
17
Research Site
Chicago, Illinois, United States, 60637
Not Yet Recruiting
18
Research Site
Louisville, Kentucky, United States, 40207
Not Yet Recruiting
19
Research Site
Baltimore, Maryland, United States, 21205
Not Yet Recruiting
20
Research Site
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
21
Research Site
Detroit, Michigan, United States, 48202
Not Yet Recruiting
22
Research Site
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
23
Research Site
Omaha, Nebraska, United States, 68198-5885
Not Yet Recruiting
24
Research Site
Santa Fe, New Mexico, United States, 87505
Actively Recruiting
25
Research Site
New York, New York, United States, 10016
Not Yet Recruiting
26
Research Site
New York, New York, United States, 10032
Not Yet Recruiting
27
Research Site
New York, New York, United States, 10065
Withdrawn
28
Research Site
Portland, Oregon, United States, 97239
Not Yet Recruiting
29
Research Site
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
30
Research Site
Philadelphia, Pennsylvania, United States, 19111
Not Yet Recruiting
31
Research Site
Pittsburgh, Pennsylvania, United States, 15212
Not Yet Recruiting
32
Research Site
Providence, Rhode Island, United States, 02903
Not Yet Recruiting
33
Research Site
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
34
Research Site
Darlinghurst, Australia, 2010
Actively Recruiting
35
Research Site
Gosford, Australia, 2250
Not Yet Recruiting
36
Research Site
Murdoch, Australia, 6150
Not Yet Recruiting
37
Research Site
Anderlecht, Belgium, 1070
Not Yet Recruiting
38
Research Site
Edegem, Belgium, 2650
Not Yet Recruiting
39
Research Site
Leuven, Belgium, 3000
Not Yet Recruiting
40
Research Site
Liège, Belgium, 4000
Not Yet Recruiting
41
Research Site
Roeselare, Belgium, 8800
Not Yet Recruiting
42
Research Site
Barretos, Brazil, 14784-400
Actively Recruiting
43
Research Site
Natal, Brazil, 59075-740
Actively Recruiting
44
Research Site
Porto Alegre, Brazil, 91350-200
Actively Recruiting
45
Research Site
Ribeirão Preto, Brazil, 14026-040
Not Yet Recruiting
46
Research Site
São Paulo, Brazil, 01246-000
Actively Recruiting
47
Research Site
Vitória, Brazil, 29043-272
Actively Recruiting
48
Research Site
Calgary, Alberta, Canada, T2N 5G2
Not Yet Recruiting
49
Research Site
Vancouver, British Columbia, Canada, VSZ 4E6
Not Yet Recruiting
50
Research Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
51
Research Site
Barrie, Ontario, Canada, L4M 6M2
Not Yet Recruiting
52
Research Site
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
53
Research Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
54
Research Site
Montreal, Quebec, Canada, H4A 3J1
Not Yet Recruiting
55
Research Site
Québec, Quebec, Canada, G1J 1Z4
Not Yet Recruiting
56
Research Site
Beijing, China, 100020
Not Yet Recruiting
57
Research Site
Beijing, China, 102218
Not Yet Recruiting
58
Research Site
Changchun, China, 130021
Not Yet Recruiting
59
Research Site
Changde, China, 415000
Actively Recruiting
60
Research Site
Changsha, China, 410005
Not Yet Recruiting
61
Research Site
Changsha, China, 410013
Suspended
62
Research Site
Chengdu, China, 610078
Not Yet Recruiting
63
Research Site
Fuzhou, China, 350005
Actively Recruiting
64
Research Site
Guangzhou, China, 510515
Not Yet Recruiting
65
Research Site
Hangzhou, China, 310022
Not Yet Recruiting
66
Research Site
Hefei, China, 230001
Actively Recruiting
67
Research Site
Lishui, China, 323000
Withdrawn
68
Research Site
Luoyang, China, 471023
Not Yet Recruiting
69
Research Site
Nanchang, China, 330000
Not Yet Recruiting
70
Research Site
Nanning, China, 530000
Not Yet Recruiting
71
Research Site
Shandong, China
Not Yet Recruiting
72
Research Site
Shanghai, China, 200032
Not Yet Recruiting
73
Research Site
Shenyang, China, 110016
Not Yet Recruiting
74
Research Site
Weifang, China, 261000
Not Yet Recruiting
75
Research Site
Wuhan, China, 430030
Not Yet Recruiting
76
Research Site
Xi'an, China, 710061
Not Yet Recruiting
77
Research Site
Clichy, France, 92118
Not Yet Recruiting
78
Research Site
Grenoble, France, 38043
Not Yet Recruiting
79
Research Site
Marseille, France, 13385
Not Yet Recruiting
80
Research Site
Vandœuvre-lès-Nancy, France, 54511
Not Yet Recruiting
81
Research Site
Aachen, Germany, 52074
Not Yet Recruiting
82
Research Site
Berlin, Germany, 10365
Not Yet Recruiting
83
Research Site
Berlin, Germany, 13353
Not Yet Recruiting
84
Research Site
Bonn, Germany, 53127
Not Yet Recruiting
85
Research Site
Düsseldorf, Germany, 40225
Not Yet Recruiting
86
Research Site
Essen, Germany, 45122
Not Yet Recruiting
87
Research Site
Frankfurt, Germany, 60488
Not Yet Recruiting
88
Research Site
Freiburg im Breisgau, Germany, 79106
Not Yet Recruiting
89
Research Site
Hamburg, Germany, 20249
Not Yet Recruiting
90
Research Site
Hamburg, Germany, 22763
Not Yet Recruiting
91
Research Site
Heidelberg, Germany, 69120
Not Yet Recruiting
92
Research Site
Heilbronn, Germany, 74078
Not Yet Recruiting
93
Research Site
Karlsruhe, Germany, 76133
Not Yet Recruiting
94
Research Site
Magdeburg, Germany, 39120
Not Yet Recruiting
95
Research Site
München, Germany, 81737
Not Yet Recruiting
96
Research Site
Ulm, Germany, 89081
Not Yet Recruiting
97
Research Site
Delhi, India, 110029
Not Yet Recruiting
98
Research Site
Hyderabad, India, 500032
Not Yet Recruiting
99
Research Site
Kolhāpur, India, 416234
Not Yet Recruiting
100
Research Site
Kolkata, India, 700063
Not Yet Recruiting
101
Research Site
Mumbai, India, 400012
Not Yet Recruiting
102
Research Site
Nashik, India, 422002
Not Yet Recruiting
103
Research Site
Surat, India, 395002
Not Yet Recruiting
104
Research Site
Castellana Grotte, Italy, 70013
Not Yet Recruiting
105
Research Site
Milan, Italy, 20132
Not Yet Recruiting
106
Research Site
Pisa, Italy, 56126
Not Yet Recruiting
107
Research Site
Rome, Italy, 00168
Not Yet Recruiting
108
Research Site
Rozzano, Italy, 20089
Not Yet Recruiting
109
Research Site
Chiba, Japan, 260-8717
Actively Recruiting
110
Research Site
Kashiwa, Japan, 227-8577
Not Yet Recruiting
111
Research Site
Kawasaki-shi, Japan, 216-8511
Not Yet Recruiting
112
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
113
Research Site
Matsuyama, Japan, 790-0024
Actively Recruiting
114
Research Site
Nagoya, Japan, 464-8681
Not Yet Recruiting
115
Research Site
Nagoya, Japan, 466-8560
Not Yet Recruiting
116
Research Site
Osaka, Japan, 541-8567
Not Yet Recruiting
117
Research Site
Suita-shi, Japan, 565-0871
Actively Recruiting
118
Research Site
Takatsuki-shi, Japan, 569-8686
Actively Recruiting
119
Research Site
Ube, Japan, 755-8505
Actively Recruiting
120
Research Site
Yokohama, Japan, 241-8515
Actively Recruiting
121
Research Site
Amsterdam, Netherlands, 1081 HV
Not Yet Recruiting
122
Research Site
Groningen, Netherlands, 9713 GZ
Not Yet Recruiting
123
Research Site
Maastricht, Netherlands, 6202 AZ
Not Yet Recruiting
124
Research Site
Utrecht, Netherlands, 3584 CX
Not Yet Recruiting
125
Research Site
Koszalin, Poland, 75-581
Not Yet Recruiting
126
Research Site
Krakow, Poland, 30-688
Not Yet Recruiting
127
Research Site
Lodz, Poland, 92-213
Not Yet Recruiting
128
Research Site
Olsztyn, Poland, 10-228
Not Yet Recruiting
129
Research Site
Warsaw, Poland, 02-034
Not Yet Recruiting
130
Research Site
Busan, South Korea, 48108
Actively Recruiting
131
Research Site
Daegu, South Korea, 41404
Not Yet Recruiting
132
Research Site
Seongnam-si, South Korea, 13496
Not Yet Recruiting
133
Research Site
Seongnam-si, South Korea, 13620
Actively Recruiting
134
Research Site
Seoul, South Korea, 03080
Actively Recruiting
135
Research Site
Seoul, South Korea, 03722
Not Yet Recruiting
136
Research Site
Seoul, South Korea, 05505
Actively Recruiting
137
Research Site
Seoul, South Korea, 06351
Actively Recruiting
138
Research Site
Seoul, South Korea, 06591
Not Yet Recruiting
139
Research Site
Barcelona, Spain, 08036
Not Yet Recruiting
140
Research Site
L'Hospitalet de Llobregat, Spain, 08908
Not Yet Recruiting
141
Research Site
Madrid, Spain, 28007
Not Yet Recruiting
142
Research Site
Madrid, Spain, 28040
Not Yet Recruiting
143
Research Site
Santander, Spain, 39008
Not Yet Recruiting
144
Research Site
Kaohsiung City, Taiwan, 82445
Actively Recruiting
145
Research Site
Kaohsiung City, Taiwan, 833
Actively Recruiting
146
Research Site
Taichung, Taiwan, 40447
Actively Recruiting
147
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
148
Research Site
Tainan, Taiwan, 704
Actively Recruiting
149
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
150
Research Site
Taipei, Taiwan, 112
Actively Recruiting
151
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
152
Research Site
Bangkok, Thailand, 10700
Not Yet Recruiting
153
Research Site
Chiang Mai, Thailand, 50200
Actively Recruiting
154
Research Site
Hat Yai, Thailand, 90110
Not Yet Recruiting
155
Research Site
Khon Kaen, Thailand, 40002
Actively Recruiting
156
Research Site
Muang, Thailand, 34000
Not Yet Recruiting
157
Research Site
Ongkharak, Thailand, 26120
Not Yet Recruiting
158
Research Site
Ankara, Turkey (Türkiye), 06100
Not Yet Recruiting
159
Research Site
Erzurum, Turkey (Türkiye), 25240
Not Yet Recruiting
160
Research Site
Istanbul, Turkey (Türkiye), 34010
Not Yet Recruiting
161
Research Site
Konya, Turkey (Türkiye), 42080
Not Yet Recruiting
162
Research Site
Seyhan, Turkey (Türkiye), 1060
Not Yet Recruiting
163
Research Site
Birmingham, United Kingdom, B15 2GW
Not Yet Recruiting
164
Research Site
Glasgow, United Kingdom, G12 OYN
Not Yet Recruiting
165
Research Site
Greater London, United Kingdom, SW3 6JJ
Not Yet Recruiting
166
Research Site
Leeds, United Kingdom, LS9 7TF
Not Yet Recruiting
167
Research Site
London, United Kingdom, NW3 2QG
Not Yet Recruiting
168
Research Site
Manchester, United Kingdom, M20 4BX
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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