Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

PHASE3RecruitingINTERVENTIONAL
Enrollment

750

Participants

Timeline

Start Date

December 4, 2023

Primary Completion Date

January 2, 2029

Study Completion Date

May 3, 2030

Conditions
Biliary Tract Cancer
Interventions
DRUG

Rilvegostomig

Rilvegostomig IV (intravenous) Q3W

DRUG

Placebo

Placebo IV (intravenous) Q3W

DRUG

Capecitabine

Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice

DRUG

Gemcitabine/Cisplatin

Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle

DRUG

S-1 [Tegafur/Oteracil/gimeracil]

S-1 \[Tegafur/Oteracil/gimeracil\] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles

Trial Locations (209)

112

ACTIVE_NOT_RECRUITING

Research Site, Taipei

333

ACTIVE_NOT_RECRUITING

Research Site, Taoyuan District

1070

RECRUITING

Research Site, Brussels

1200

RECRUITING

Research Site, Brussels

2050

ACTIVE_NOT_RECRUITING

Research Site, Camperdown

2145

ACTIVE_NOT_RECRUITING

Research Site, Westmead

2650

RECRUITING

Research Site, Edegem

2730

RECRUITING

Research Site, Herlev

3000

RECRUITING

Research Site, Leuven

3021

WITHDRAWN

Research Site, Reservoir

3168

ACTIVE_NOT_RECRUITING

Research Site, Clayton

4103

RECRUITING

Research Site, Leipzig

6150

ACTIVE_NOT_RECRUITING

Research Site, Murdoch

8035

ACTIVE_NOT_RECRUITING

Research Site, Barcelona

10002

ACTIVE_NOT_RECRUITING

Research Site, Taipei

11501

RECRUITING

Research Site, Mineola

11725

RECRUITING

Research Site, Commack

13273

RECRUITING

Research Site, Marseille

13353

RECRUITING

Research Site, Berlin

13620

ACTIVE_NOT_RECRUITING

Research Site, Seongnam-si

19111

WITHDRAWN

Research Site, Philadelphia

19144

RECRUITING

Research Site, Philadelphia

20007

RECRUITING

Research Site, Washington D.C.

20010

WITHDRAWN

Research Site, Washington D.C.

20089

RECRUITING

Research Site, Rozzano

20133

RECRUITING

Research Site, Milan

20162

RECRUITING

Research Site, Milan

21201

RECRUITING

Research Site, Baltimore

22763

RECRUITING

Research Site, Hamburg

23538

RECRUITING

Research Site, Lübeck

25240

RECRUITING

Research Site, Erzurum

28007

ACTIVE_NOT_RECRUITING

Research Site, Madrid

28040

ACTIVE_NOT_RECRUITING

Research Site, Madrid

28041

ACTIVE_NOT_RECRUITING

Research Site, Madrid

29011

ACTIVE_NOT_RECRUITING

Research Site, Málaga

30000

ACTIVE_NOT_RECRUITING

Research Site, Naimuang

30322

RECRUITING

Research Site, Atlanta

31005

ACTIVE_NOT_RECRUITING

Research Site, Pamplona

31059

RECRUITING

Research Site, Toulouse

32224

RECRUITING

Research Site, Jacksonville

32611

WITHDRAWN

Research Site, Gainesville

32701

RECRUITING

Research Site, Altamonte Springs

33000

ACTIVE_NOT_RECRUITING

Research Site, Si Sa Ket

33604

RECRUITING

Research Site, Pessac

34000

ACTIVE_NOT_RECRUITING

Research Site, Muang

34098

RECRUITING

Research Site, Fatih-Istanbul

34295

RECRUITING

Research Site, Montpellier

34722

WITHDRAWN

Research Site, Istanbul

35000

RECRUITING

Research Site, Rennes

35128

RECRUITING

Research Site, Padua

35233

RECRUITING

Research Site, Birmingham

37232

WITHDRAWN

Research Site, Nashville

39008

ACTIVE_NOT_RECRUITING

Research Site, Santander

40002

ACTIVE_NOT_RECRUITING

Research Site, Khon Kaen

40447

ACTIVE_NOT_RECRUITING

Research Site, Taichung

40506

RECRUITING

Research Site, Lexington

40705

WITHDRAWN

Research Site, Taichung

44137

RECRUITING

Research Site, Dortmund

45122

WITHDRAWN

Research Site, Essen

48129

RECRUITING

Research Site, Münster

49546

RECRUITING

Research Site, Grand Rapids

50134

RECRUITING

Research Site, Florence

50200

ACTIVE_NOT_RECRUITING

Research Site, Muang

50937

WITHDRAWN

Research Site, Cologne

52242

RECRUITING

Research Site, Iowa City

53127

RECRUITING

Research Site, Bonn

55139

RECRUITING

Research Site, Samsun

55905

RECRUITING

Research Site, Rochester

56126

RECRUITING

Research Site, Pisa

60488

RECRUITING

Research Site, Frankfurt

60637

RECRUITING

Research Site, Chicago

63110

RECRUITING

Research Site, St Louis

66160

RECRUITING

Research Site, Kansas City

67033

RECRUITING

Research Site, Strasbourg

69120

RECRUITING

Research Site, Heidelberg

70121

RECRUITING

Research Site, New Orleans

70174

RECRUITING

Research Site, Stuttgart

70403

ACTIVE_NOT_RECRUITING

Research Site, Tainan City

72076

RECRUITING

Research Site, Tübingen

73039

RECRUITING

Research Site, Tricase, Lecce

73730

RECRUITING

Research Site, Esslingen A. N.

75246

RECRUITING

Research Site, Dallas

75248

RECRUITING

Research Site, Paris

75702

RECRUITING

Research Site, Tyler

80045

RECRUITING

Research Site, Aurora

80129

RECRUITING

Research Site, Littleton

80206

WITHDRAWN

Research Site, Denver

81377

RECRUITING

Research Site, München

81737

RECRUITING

Research Site, München

82445

ACTIVE_NOT_RECRUITING

Research Site, Kaohsiung City

83301

ACTIVE_NOT_RECRUITING

Research Site, Kaohsiung City

85054

RECRUITING

Research Site, Phoenix

89081

RECRUITING

Research Site, Ulm

90048

WITHDRAWN

Research Site, West Hollywood

90089

RECRUITING

Research Site, Los Angeles

90110

ACTIVE_NOT_RECRUITING

Research Site, Hat Yai

91010

WITHDRAWN

Research Site, Duarte

91054

RECRUITING

Research Site, Erlangen

92663

WITHDRAWN

Research Site, Newport Beach

92868

RECRUITING

Research Site, Orange

94305

RECRUITING

Research Site, Stanford

94800

RECRUITING

Research Site, Villejuif

98684

RECRUITING

Research Site, Vancouver

100142

RECRUITING

Research Site, Beijing

110004

RECRUITING

Research Site, Shenyang

110076

ACTIVE_NOT_RECRUITING

Research Site, New Delhi

110085

ACTIVE_NOT_RECRUITING

Research Site, New Delhi

110088

ACTIVE_NOT_RECRUITING

Research Site, Delhi

130021

RECRUITING

Research Site, Changchun

150081

RECRUITING

Research Site, Harbin

201114

RECRUITING

Research Site, Shanghai

210029

RECRUITING

Research Site, Nanjing

221005

ACTIVE_NOT_RECRUITING

Research Site, Varanasi

230001

RECRUITING

Research Site, Hefei

230601

RECRUITING

Research Site, Hefei

300060

RECRUITING

Research Site, Tianjin

310009

RECRUITING

Research Site, Hangzhou

323000

RECRUITING

Research Site, Lishui

330006

ACTIVE_NOT_RECRUITING

Research Site, Nanchang

350005

ACTIVE_NOT_RECRUITING

Research Site, Fuzhou

391760

WITHDRAWN

Research Site, Vadodara

400012

ACTIVE_NOT_RECRUITING

Research Site, Mumbai

410013

ACTIVE_NOT_RECRUITING

Research Site, Changsha

430071

ACTIVE_NOT_RECRUITING

Research Site, Wuhan

430079

ACTIVE_NOT_RECRUITING

Research Site, Wuhan

450008

RECRUITING

Research Site, Zhengzhou

510060

RECRUITING

Research Site, Guangzhou

510515

RECRUITING

Research Site, Guangzhou

530021

RECRUITING

Research Site, Nanning

550044

RECRUITING

Research Site, Guiyang

570017

ACTIVE_NOT_RECRUITING

Research Site, Mysuru

610000

RECRUITING

Research Site, Chengdu

610072

RECRUITING

Research Site, Chengdu

618000

RECRUITING

Research Site, Deyang

650101

RECRUITING

Research Site, Kunming

700094

ACTIVE_NOT_RECRUITING

Research Site, Kolkata

710061

RECRUITING

Research Site, Xi'an

730000

ACTIVE_NOT_RECRUITING

Research Site, Lanzhou

999077

ACTIVE_NOT_RECRUITING

Research Site, Hong Kong

2100008

RECRUITING

Research Site, Nanjing

59075-740

ACTIVE_NOT_RECRUITING

Research Site, Natal

90035-000

ACTIVE_NOT_RECRUITING

Research Site, Porto Alegre

91350-200

ACTIVE_NOT_RECRUITING

Research Site, Porto Alegre

97015-450

COMPLETED

Research Site, Santa Maria

09060-870

ACTIVE_NOT_RECRUITING

Research Site, Santo André

01246-000

ACTIVE_NOT_RECRUITING

Research Site, São Paulo

01327-001

ACTIVE_NOT_RECRUITING

Research Site, São Paulo

29043-260

ACTIVE_NOT_RECRUITING

Research Site, Vitória

VSZ 4E6

RECRUITING

Research Site, Vancouver

E1C 6Z8

RECRUITING

Research Site, Moncton

B3H 2Y9

RECRUITING

Research Site, Halifax

L6R 3J7

WITHDRAWN

Research Site, Brampton

K7L 2V7

RECRUITING

Research Site, Kingston

N6C 2R5

RECRUITING

Research Site, London

L5M 2N1

WITHDRAWN

Research Site, Mississauga

K1H 8L6

RECRUITING

Research Site, Ottawa

M4N 3M5

RECRUITING

Research Site, Toronto

M5G 2M9

RECRUITING

Research Site, Toronto

H4A 3J1

RECRUITING

Research Site, Montreal

G1J 1Z4

RECRUITING

Research Site, Québec

CN-100730

RECRUITING

Research Site, Beijing

Unknown

RECRUITING

Research Site, Shandong

01370

RECRUITING

Research Site, Dresden

00000

WITHDRAWN

Research Site, Hong Kong

ACTIVE_NOT_RECRUITING

Research Site, Shatin

104-0045

WITHDRAWN

Research Site, Chūōku

734-8551

RECRUITING

Research Site, Hiroshima

227-8577

RECRUITING

Research Site, Kashiwa

362-0806

RECRUITING

Research Site, Kitaadachi-gun

135-8550

RECRUITING

Research Site, Kōtoku

181-8611

RECRUITING

Research Site, Mitaka-shi

464-8681

RECRUITING

Research Site, Nagoya

466-8560

RECRUITING

Research Site, Nagoya

541-8567

RECRUITING

Research Site, Osaka

980-8574

RECRUITING

Research Site, Sendai

565-0871

RECRUITING

Research Site, Suita-shi

930-0194

RECRUITING

Research Site, Toyama

755-8505

RECRUITING

Research Site, Ube

641-8510

RECRUITING

Research Site, Wakayama

236-0004

RECRUITING

Research Site, Yokohama

241-8515

RECRUITING

Research Site, Yokohama

0379

RECRUITING

Research Site, Oslo

85-796

RECRUITING

Research Site, Bydgoszcz

40-514

WITHDRAWN

Research Site, Katowice

75-581

WITHDRAWN

Research Site, Koszalin

31-501

RECRUITING

Research Site, Krakow

20-080

RECRUITING

Research Site, Lublin

37-700

RECRUITING

Research Site, Przemyśl

97-200

WITHDRAWN

Research Site, Tomaszów Mazowiecki

02-034

RECRUITING

Research Site, Warsaw

03080

ACTIVE_NOT_RECRUITING

Research Site, Seoul

03722

ACTIVE_NOT_RECRUITING

Research Site, Seoul

05505

ACTIVE_NOT_RECRUITING

Research Site, Seoul

06351

ACTIVE_NOT_RECRUITING

Research Site, Seoul

06591

ACTIVE_NOT_RECRUITING

Research Site, Seoul

08036

ACTIVE_NOT_RECRUITING

Research Site, Barcelona

08908

ACTIVE_NOT_RECRUITING

Research Site, L'Hospitalet de Llobregat

06100

RECRUITING

Research Site, Ankara

06230

RECRUITING

Research Site, Ankara

06620

WITHDRAWN

Research Site, Ankara

07100

RECRUITING

Research Site, Antalya

CB2 0QQ

RECRUITING

Research Site, Cambridge

B15 2WB

RECRUITING

Research Site, Edgbaston

G12 0YN

RECRUITING

Research Site, Glasgow, Scotland

NW3 2QG

RECRUITING

Research Site, London

W12 0HS

WITHDRAWN

Research Site, London

WC1E 6BT

RECRUITING

Research Site, London

M20 4BX

RECRUITING

Research Site, Manchester

SM2 5PT

RECRUITING

Research Site, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY