Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

620

Participants

Timeline

Start Date

August 12, 2024

Primary Completion Date

June 12, 2028

Study Completion Date

May 16, 2029

Conditions
Biliary Tract Cancer
Interventions
DRUG

Gemcitabine

Standard of care chemotherapy by intravenous infusion

DRUG

Cisplatin

Standard of care chemotherapy by intravenous infusion

DRUG

Durvalumab

Standard of care immunotherapy by intravenous infusion

DRUG

Trastuzumab deruxtecan

Experimental therapy by intravenous infusion

DRUG

Rilvegostomig

Experimental therapy by intravenous infusion

DIAGNOSTIC_TEST

Agilent HercepTest™ mAb pharmDx

"A semi-quantitative immunohistochemical assay to determine HER2 overexpression in FFPE breast cancer tissues routinely processed for histological evaluation.~Based on a primary monoclonal rabbit antibody which visualises Her2 overexpression utilising a fully automated IHC platform (Dako Omnis)."

DIAGNOSTIC_TEST

Ventana PD-L1 SP263 assay

A qualitative immunohistochemical assay to determine the level of PD-L1 expression in FFPE non-small cell lung cancer (NSCLC) tissues routinely processed for histological evaluation. Based on a rabbit monoclonal anti-PD-L1 clone SP263 which visualises PD-L1 protein using a VENTANA BenchMark ULTRA instrument

Trial Locations (255)

333

RECRUITING

Research Site, Taoyuan District

824

NOT_YET_RECRUITING

Research Site, Kaohsiung City

833

RECRUITING

Research Site, Kaohsiung City

1070

NOT_YET_RECRUITING

Research Site, Anderlecht

1090

NOT_YET_RECRUITING

Research Site, Vienna

1112

NOT_YET_RECRUITING

Research Site, Quezon City

1229

NOT_YET_RECRUITING

Research Site, Makati

1605

NOT_YET_RECRUITING

Research Site, Pasig

2139

NOT_YET_RECRUITING

Research Site, Concord

2650

NOT_YET_RECRUITING

Research Site, Edegem

2700

NOT_YET_RECRUITING

Research Site, Wiener Neustadt

3000

ACTIVE_NOT_RECRUITING

Research Site, Leuven

3168

RECRUITING

Research Site, Clayton

4000

NOT_YET_RECRUITING

Research Site, Liège

4010

NOT_YET_RECRUITING

Research Site, Linz

4032

NOT_YET_RECRUITING

Research Site, Chermside

4103

NOT_YET_RECRUITING

Research Site, Leipzig

5020

NOT_YET_RECRUITING

Research Site, Salzburg

6000

NOT_YET_RECRUITING

Research Site, Cebu City

6009

RECRUITING

Research Site, Nedlands

8036

NOT_YET_RECRUITING

Research Site, Graz

8800

NOT_YET_RECRUITING

Research Site, Roeselare

9000

NOT_YET_RECRUITING

Research Site, Ghent

10002

RECRUITING

Research Site, Taipei

10032

WITHDRAWN

Research Site, New York

10400

NOT_YET_RECRUITING

Research Site, Bangkok

10990

RECRUITING

Research Site, George Town

11426

NOT_YET_RECRUITING

Research Site, Riyadh

11525

NOT_YET_RECRUITING

Research Site, Riyadh

12713

NOT_YET_RECRUITING

Research Site, Riyadh

13008

NOT_YET_RECRUITING

Research Site, Marseille

13353

NOT_YET_RECRUITING

Research Site, Berlin

13496

RECRUITING

Research Site, Seongnam-si

13620

RECRUITING

Research Site, Gyeonggi-do

20089

NOT_YET_RECRUITING

Research Site, Rozzano

20132

NOT_YET_RECRUITING

Research Site, Milan

20162

NOT_YET_RECRUITING

Research Site, Milan

21079

NOT_YET_RECRUITING

Research Site, Dijon

21204

NOT_YET_RECRUITING

Research Site, Towson

22031

RECRUITING

Research Site, Fairfax

22763

NOT_YET_RECRUITING

Research Site, Hamburg

23538

NOT_YET_RECRUITING

Research Site, Lübeck

25040

NOT_YET_RECRUITING

Research Site, Yakutiye

26120

RECRUITING

Research Site, Ongkharak

28007

NOT_YET_RECRUITING

Research Site, Madrid

28040

NOT_YET_RECRUITING

Research Site, Madrid

28041

NOT_YET_RECRUITING

Research Site, Madrid

29010

NOT_YET_RECRUITING

Research Site, Málaga

29605

NOT_YET_RECRUITING

Research Site, Greenville

29609

NOT_YET_RECRUITING

Research Site, Brest

30000

RECRUITING

Research Site, Naimuang

30309

RECRUITING

Research Site, Atlanta

31444

NOT_YET_RECRUITING

Research Site, Dammam

32224

RECRUITING

Research Site, Jacksonville

33000

RECRUITING

Research Site, Si Sa Ket

33200

NOT_YET_RECRUITING

Research Site, Mezitli

33401

RECRUITING

Research Site, West Palm Beach

33604

NOT_YET_RECRUITING

Research Site, Pessac

33606

NOT_YET_RECRUITING

Research Site, Tampa

33705

RECRUITING

Research Site, St. Petersburg

33901

NOT_YET_RECRUITING

Research Site, Fort Myers

34218

NOT_YET_RECRUITING

Research Site, Istanbul

34295

NOT_YET_RECRUITING

Research Site, Montpellier

35128

NOT_YET_RECRUITING

Research Site, Padua

35340

NOT_YET_RECRUITING

Research Site, Izmir

37075

NOT_YET_RECRUITING

Research Site, Göttingen

37203

WITHDRAWN

Research Site, Nashville

39008

NOT_YET_RECRUITING

Research Site, Santander

40002

RECRUITING

Research Site, Khon Kaen

40447

NOT_YET_RECRUITING

Research Site, Taichung

43210

NOT_YET_RECRUITING

Research Site, Columbus

44195

NOT_YET_RECRUITING

Research Site, Cleveland

47000

NOT_YET_RECRUITING

Research Site, Mueang

48108

RECRUITING

Research Site, Busan

48202

WITHDRAWN

Research Site, Detroit

49503

RECRUITING

Research Site, Grand Rapids

50134

NOT_YET_RECRUITING

Research Site, Florence

50200

RECRUITING

Research Site, Muang

50586

RECRUITING

Research Site, Kuala Lumpur

50937

NOT_YET_RECRUITING

Research Site, Cologne

53127

NOT_YET_RECRUITING

Research Site, Bonn

55905

RECRUITING

Research Site, Rochester

58128

RECRUITING

Research Site, Hwasun-gun

59037

NOT_YET_RECRUITING

Research Site, Lille

59100

RECRUITING

Research Site, Kuala Lumpur

60488

NOT_YET_RECRUITING

Research Site, Frankfurt

60612

NOT_YET_RECRUITING

Research Site, Chicago

60714

RECRUITING

Research Site, Niles

63110

RECRUITING

Research Site, St Louis

64132

NOT_YET_RECRUITING

Research Site, Kansas City

69008

NOT_YET_RECRUITING

Research Site, Lyon

70000

RECRUITING

Research Site, Ho Chi Minh City

73039

NOT_YET_RECRUITING

Research Site, Tricase

75246

RECRUITING

Research Site, Dallas

76104

WITHDRAWN

Research Site, Fort Worth

RECRUITING

Research Site, Fort Worth

77030

RECRUITING

Research Site, Houston

77584

WITHDRAWN

Research Site, Pearland

77900

NOT_YET_RECRUITING

Research Site, Olomouc

78217

WITHDRAWN

Research Site, San Antonio

78258

WITHDRAWN

Research Site, San Antonio

78705

WITHDRAWN

Research Site, Austin

79106

NOT_YET_RECRUITING

Research Site, Freiburg im Breisgau

80128

NOT_YET_RECRUITING

Research Site, Napoli

80131

NOT_YET_RECRUITING

Research Site, Naples

81100

RECRUITING

Research Site, Johor Bahru

83814

NOT_YET_RECRUITING

Research Site, Coeur d'Alene

85259

RECRUITING

Research Site, Scottsdale

85704

RECRUITING

Research Site, Tucson

85719

NOT_YET_RECRUITING

Research Site, Tucson

87102

WITHDRAWN

Research Site, Albuquerque

89081

NOT_YET_RECRUITING

Research Site, Ulm

90017

RECRUITING

Research Site, Los Angeles

90089

RECRUITING

Research Site, Los Angeles

90110

RECRUITING

Research Site, Hat Yai

90720

SUSPENDED

Research Site, Los Alamitos

92093

RECRUITING

Research Site, La Jolla

92118

NOT_YET_RECRUITING

Research Site, Clichy

92835

RECRUITING

Research Site, Fullerton

93586

RECRUITING

Research Site, Kuching

94143

RECRUITING

Research Site, San Francisco

94800

NOT_YET_RECRUITING

Research Site, Villejuif

97080

NOT_YET_RECRUITING

Research Site, Würzburg

100000

NOT_YET_RECRUITING

Research Site, Hanoi

RECRUITING

Research Site, Hanoi

100021

WITHDRAWN

Research Site, Beijing

100024

NOT_YET_RECRUITING

Research Site, Beijing

100034

NOT_YET_RECRUITING

Research Site, Beijing

100142

RECRUITING

Research Site, Beijing

110004

RECRUITING

Research Site, Shenyang

110029

NOT_YET_RECRUITING

Research Site, Delhi

110088

NOT_YET_RECRUITING

Research Site, Delhi

130021

NOT_YET_RECRUITING

Research Site, Changchun

150081

RECRUITING

Research Site, Harbin

200001

NOT_YET_RECRUITING

Research Site, Shanghai

201107

NOT_YET_RECRUITING

Research Site, Shanghai

201114

RECRUITING

Research Site, Shanghai

221005

WITHDRAWN

Research Site, Varanasi

226001

RECRUITING

Research Site, Nantong

230001

RECRUITING

Research Site, Hefei

230601

RECRUITING

Research Site, Hefei

233004

RECRUITING

Research Site, Bengbu

248016

NOT_YET_RECRUITING

Research Site, Dehradun

250117

RECRUITING

Research Site, Jinan

300060

RECRUITING

Research Site, Tianjin

310016

RECRUITING

Research Site, Hangzhou

330029

RECRUITING

Research Site, Nanchang

350007

RECRUITING

Research Site, Fuzhou

391760

NOT_YET_RECRUITING

Research Site, Vadodara

400012

NOT_YET_RECRUITING

Research Site, Mumbai

400030

WITHDRAWN

Research Site, Chongqing

410013

RECRUITING

Research Site, Changsha

415003

RECRUITING

Research Site, Changde

430079

RECRUITING

Research Site, Wuhan

450008

RECRUITING

Research Site, Zhengzhou

450052

RECRUITING

Research Site, Zhengzhou

460000

RECRUITING

Research Site, Vinh

471000

RECRUITING

Research Site, Luoyang

510080

RECRUITING

Research Site, Guangzhou

510515

RECRUITING

Research Site, Guangzhou

518116

NOT_YET_RECRUITING

Research Site, Shenzhen

530021

RECRUITING

Research Site, Nanning

550044

RECRUITING

Research Site, Guiyang

610041

RECRUITING

Research Site, Chengdu

610078

RECRUITING

Research Site, Chengdu

650101

NOT_YET_RECRUITING

Research Site, Kunming

700000

RECRUITING

Research Site, Ho Chi Minh City

NOT_YET_RECRUITING

Research Site, Ho Chi Minh City

700054

NOT_YET_RECRUITING

Research Site, Kolkata

700094

NOT_YET_RECRUITING

Research Site, Kolkata

710061

RECRUITING

Research Site, Xi'an

999077

NOT_YET_RECRUITING

Research Site, Hong Kong

01655

WITHDRAWN

Research Site, Worcester

59012-300

NOT_YET_RECRUITING

Research Site, Natal

90035-000

RECRUITING

Research Site, Porto Alegre

91350-200

NOT_YET_RECRUITING

Research Site, Porto Alegre

97015-450

NOT_YET_RECRUITING

Research Site, Santa Maria

01246-000

RECRUITING

Research Site, São Paulo

05652-9000

NOT_YET_RECRUITING

Research Site, São Paulo

29043-272

NOT_YET_RECRUITING

Research Site, Vitória

T6G 1Z2

NOT_YET_RECRUITING

Research Site, Edmonton

B3H 1V7

RECRUITING

Research Site, Halifax

L6R 3J7

NOT_YET_RECRUITING

Research Site, Brampton

M5G 2M9

RECRUITING

Research Site, Toronto

H3A 1A1

RECRUITING

Research Site, Montreal

Unknown

RECRUITING

Research Site, Beijing

NOT_YET_RECRUITING

Research Site, Taichung

RECRUITING

Research Site, Taipei

625 00

NOT_YET_RECRUITING

Research Site, Brno

656 53

NOT_YET_RECRUITING

Research Site, Brno

500 05

NOT_YET_RECRUITING

Research Site, Hradec Králové

100 34

NOT_YET_RECRUITING

Research Site, Prague

150 06

NOT_YET_RECRUITING

Research Site, Prague

30029, Cedex

NOT_YET_RECRUITING

Research Site, Nîmes

01370

NOT_YET_RECRUITING

Research Site, Dresden

81377, DE

NOT_YET_RECRUITING

Research Site, München

00000

NOT_YET_RECRUITING

Research Site, Shatin

00133

NOT_YET_RECRUITING

Research Site, Roma

113-8431

RECRUITING

Research Site, Bunkyō City

113-8603

RECRUITING

Research Site, Bunkyō City

113-8677

RECRUITING

Research Site, Bunkyō City

260-0877

RECRUITING

Research Site, Chiba

721-8511

RECRUITING

Research Site, Fukuyama-shi

573-1191

RECRUITING

Research Site, Hirakata-shi

734-8551

RECRUITING

Research Site, Hiroshima

920-8641

NOT_YET_RECRUITING

Research Site, Kanazawa

227-8577

RECRUITING

Research Site, Kashiwa

216-8511

RECRUITING

Research Site, Kawasaki-shi

761-0793

RECRUITING

Research Site, Kita-gun

362-0806

RECRUITING

Research Site, Kitaadachi-gun

135-8550

RECRUITING

Research Site, Kōtoku

860-8556

RECRUITING

Research Site, Kumamoto

606-8507

RECRUITING

Research Site, Kyoto

371-8511

RECRUITING

Research Site, Maebashi

181-8611

RECRUITING

Research Site, Mitaka-shi

464-8681

RECRUITING

Research Site, Nagoya

466-8560

NOT_YET_RECRUITING

Research Site, Nagoya

541-8567

RECRUITING

Research Site, Osaka

545-8586

RECRUITING

Research Site, Osaka

591-8025

RECRUITING

Research Site, Sakaishi

060-8543

NOT_YET_RECRUITING

Research Site, Sapporo

980-8574

RECRUITING

Research Site, Sendai

160-8582

RECRUITING

Research Site, Shinjuku-ku

565-0871

RECRUITING

Research Site, Suita

411-8777

NOT_YET_RECRUITING

Research Site, Sunto-gun

755-8505

RECRUITING

Research Site, Ube-shi

641-8510

RECRUITING

Research Site, Wakayama

241-8515

RECRUITING

Research Site, Yokohama

3015 GD

WITHDRAWN

Research Site, Rotterdam

15-027

NOT_YET_RECRUITING

Research Site, Bialystok

40-514

NOT_YET_RECRUITING

Research Site, Katowice

31-501

NOT_YET_RECRUITING

Research Site, Krakow

20-080

NOT_YET_RECRUITING

Research Site, Lublin

02-034

NOT_YET_RECRUITING

Research Site, Warsaw

50-556

WITHDRAWN

Research Site, Wroclaw

974 01

NOT_YET_RECRUITING

Research Site, Banská Bystrica

833 10

NOT_YET_RECRUITING

Research Site, Bratislava

041 91

NOT_YET_RECRUITING

Research Site, Košice

036 59

NOT_YET_RECRUITING

Research Site, Martin

917 75

NOT_YET_RECRUITING

Research Site, Trnava

03080

RECRUITING

Research Site, Seoul

05505

RECRUITING

Research Site, Seoul

06351

RECRUITING

Research Site, Seoul

06591

RECRUITING

Research Site, Seoul

120-752

RECRUITING

Research Site, Seoul

08035

NOT_YET_RECRUITING

Research Site, Barcelona

00807

NOT_YET_RECRUITING

Research Site, Kaohsiung City

06230

NOT_YET_RECRUITING

Research Site, Altındağ

07100

NOT_YET_RECRUITING

Research Site, Antalya

B15 2GW

NOT_YET_RECRUITING

Research Site, Birmingham

DD1 9SY

NOT_YET_RECRUITING

Research Site, Dundee

G12 0YN

NOT_YET_RECRUITING

Research Site, Glasgow

SW3 6JJ

NOT_YET_RECRUITING

Research Site, Greater London

LS9 7TF

NOT_YET_RECRUITING

Research Site, Leeds

EC1A 7BE

NOT_YET_RECRUITING

Research Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY