Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

June 7, 2024

Primary Completion Date

August 31, 2028

Study Completion Date

March 31, 2029

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Zanzalintinib

Specified doses on specified days

DRUG

Zanzalintinib-matched Placebo

Specified doses on specified days

BIOLOGICAL

Pembrolizumab

Specified doses on specified days

Trial Locations (168)

129

Exelixis Clinical Site #152, Bogotá

807

Exelixis Clinical Site #145, Kaohsiung City

1083

Exelixis Clinical Site #125, Budapest

1090

Exelixis Clinical Site #166, Vienna

1200

Exelixis Clinical Site #22, Brussels

1330

Exelixis Clinical Site #15, Sofia

1527

Exelixis Clinical Site #11, Sofia

1797

Exelixis Clinical Site #54, Sofia

2444

Exelixis Clinical Site #57, Port Macquarie

3100

Exelixis Clinical Site #131, Salgótarján

3722

Exelixis Clinical Site #5, Seoul

4004

Exelixis Clinical Site #25, Plovdiv

4010

Exelixis Clinical Site #156, Linz

5000

Exelixis Clinical Site # 46, Adelaide

5020

Exelixis Clinical Site #42, Salzburg

5042

Exelixis Clinical Site #154, Bedford Park

5505

Exelixis Clinical Site #63, Seoul

6000

Exelixis Clinical Site #106, Charleroi

Exelixis Clinical Site #99, Kecskemét

6150

Exelixis Clinical Site #39, Murdoch

6273

Exelixis Clinical Site #12, Seoul

6591

Exelixis Clinical Site #6, Seoul

6800

Exelixis Clinical Site #14, Libramont

7002

Exelixis Clinical Site #94, Rousse

7100

Exelixis Clinical Site #147, Szekszárd

8308

Exelixis Clinical Site #29, Seoul

9100

Exelixis Clinical Site #37, Sint-Niklaas

10060

Exelixis Clinical Site #21, Candiolo

10330

Exelixis Clinical Site #80, Bangkok

10700

Exelixis Clinical Site #71, Bangkoknoi

11217

Exelixis Clinical Site #142, Taipei

11527

Exelixis Clinical Site #155, Athens

11967

Exelixis Clinical Site #3, Shirley

12462

Exelixis Clinical Site #129, Athens

13005

Exelixis Clinical Site #28, Marseille

13127

Exelixis Clinical Site #33, Santiago

14059

Exelixis Clinical Site #34, Prague

15006

Exelixis Clinical Site #48, Prague

15009

Exelixis Clinical Site #130, A Coruña

16247

Exelixis Clinical Site #30, Suwon

16499

Exelixis Clinical Site #17, Suwon

17007

Exelixis Clinical Site #113, Girona

18081

Exelixis Clinical Site #36, Prague

20089

Exelixis Clinical Site #124, Rozzano

20133

Exelixis Clinical Site #81, Milan

20141

Exelixis Clinical Site #55, Milan

21000

Exelixis Clinical Site #144, Dijon

24014

Exelixis Clinical Site #43, Roanoke

25124

Exelixis Clinical Site #35, Brescia

27710

Exelixis Clinical Site #95, Durham

27893

Exelixis Clinical Site #117, Wilson

28027

Exelixis Clinical Site #134, Madrid

28033

Exelixis Clinical Site #111, Madrid

28034

Exelixis Clinical Site #32, Madrid

28040

Exelixis Clinical Site #59, Madrid

28046

Exelixis Clinical Site #31, Madrid

30322

Exelixis Clinical Site #82, Atlanta

30607

Exelixis Clinical Site #123, Athens

31008

Exelixis Clinical Site #136, Pamplona

32763

Exelixis Clinical Site #1, Orange City

33075

Exelixis Clinical Site #16, Bordeaux

33305

Exelixis Clinical Site #165, Taoyuan District

35042

Exelixis Clinical Site #44, Rennes

35392

Exelixis Clinical Site #167, Giessen

37134

Exelixis Clinical Site #10, Verona

40447

Exelixis Clinical Site #164, Taichung

41009

Exelixis Clinical Site #126, Seville

41500

Exelixis Clinical Site #159, Larissa

42270

Exelixis Clinical Site #108, Saint Priest En Jarez

44160

Exelixis Clinical Site #114, Guadalajara

44280

Exelixis Clinical Site #168, Guadalajara

46009

Exelixis Clinical Site #153, Valencia

49201

Exelixis Clinical Site #13, Busan

49267

Exelixis Clinical Site #7, Busan

50009

Exelixis Clinical Site #41, Zaragoza

50200

Exelixis Clinical Site #56, Chiang Mai

50309

Exelixis Clinical Site #62, Des Moines

50586

Exelixis Clinical Site #60, Kuala Lumpur

50612

Exelixis Clinical Site #9, Yangsan

52242

Exelixis Clinical Site #100, Iowa City

54622

Exelixis Clinical Site #120, Thessaloniki

54907

Exelixis Clinical Site #69, Jeonju

Exelixis Clinical Site #8, Jeonju

56403

Exelixis Clinical Site #150, Thessaloniki

57001

Exelixis Clinical Site #128, Thessaloniki

59000

Exelixis Clinical Site #140, Lille

59100

Exelixis Clinical Site #72, Kuala Lumpur

60611

Exelixis Clinical Site #19, Chicago

62250

Exelixis Clinical Site #61, Putrajaya

63110

Exelixis Clinical Site #4, St Louis

69004

Exelixis Clinical Site #112, Pierre-Bénite

69008

Exelixis Clinical Site #70, Lyon

72000

Exelixis Clinical Site #107, Le Mans

74101

Exelixis Clinical Site #49, Nový Jičín

75013

Exelixis Clinical Site #26, Paris

76800

Exelixis Clinical Site #119, San Juan del Río

77900

Exelixis Clinical Site #58, Olomouc

80020

Exelixis Clinical Site #96, Barranquilla

80131

Exelixis Clinical Site #18, Napoli

86021

Exelixis Clinical Site #105, Poitiers

90110

Exelixis Clinical Site #79, Hat Yai

91775

Exelixis Clinical Site #27, Trnava

92835

Exelixis Clinical Site #2, Fullerton

94805

Exelixis Clinical Site #66, Villejuif

95123

Exelixis Clinical Site #45, Catania

100229

Exelixis Clinical Site #118, Taipei

100337

Exelixis Clinical Site #127, Ploieşti

200542

Exelixis Clinical Site #20, Craiova

300239

Exelixis Clinical Site #143, Timișoara

400641

Exelixis Clinical Site #24, Cluj-Napoca

407280

Exelixis Clinical Site #104, Floreşti

520001

Exelixis Clinical Site #146, Pasto

660001

Exelixis Clinical Site #149, Pereira

911201

Exelixis Clinical Site #74, Jerusalem

1221020

Exelixis Clinical Site #88, São Paulo

2540364

Exelixis Clinical Site #40, Viña del Mar

3109601

Exelixis Clinical Site #132, Haifa

3436212

Exelixis Clinical Site #85, Haifa

3465586

Exelixis Clinical Site #50, Talca

5090000

Exelixis Clinical Site #51, Valdivia

5265601

Exelixis Clinical Site #122, Ramat Gan

6423906

Exelixis Clinical Site #86, Tel Aviv

6810002

Exelixis Clinical Site #103, Floridablanca

7500859

Exelixis Clinical Site #52, Santiago

8331143

Exelixis Clinical Site #38, Santiago

8940577

Exelixis Clinical Site #109, Santiago

33612-9497

Exelixis Clinical Site #163, Tampa

03756

Exelixis Clinical Site #148, Lebanon

08103

Exelixis Clinical Site #158, Camden

S2000KZE

Exelixis Clinical Site #73, Rosario

C1428AQK

Exelixis Clinical Site #91, Buenos Aires

C1015ABO

Exelixis Clinical Site # 47, Ciudad Autonoma de Buenos Aire

C1056ABJ

Exelixis Clinical Site #53, Ciudad Autonoma de Buenos Aire

X5000JHQ

Exelixis Clinical Site #93, Córdoba

X5008HHW

Exelixis Clinical Site #64, Córdoba

B2700CPM

Exelixis Clinical Site #157, Pergamino

S3000FFU

Exelixis Clinical Site #92, Santa Fe

NSW 2050

Exelixis Clinical Site #137, Camperdown

99010-260

Exelixis Clinical Site #68, Passo Fundo

91350 200

Exelixis Clinical Site #90, Porto Alegre

17210 190

Exelixis Clinical Site #110, Jaú

09060-650

Exelixis Clinical Site #65, Santo André

15090 000

Exelixis Clinical Site #83, São José do Rio Preto

14784 400

Exelixis Clinical Site #116, Barretos

80810 050

Exelixis Clinical Site #75, Curitiba

81520 060

Exelixis Clinical Site #101, Curitiba

90110 270

Exelixis Clinical Site #97, Porto Alegre

50070 225

Exelixis Clinical Site #102, Recife

20230 130

Exelixis Clinical Site #87, Rio de Janeiro

01323 030

Exelixis Clinical Site #76, São Paulo

01525 001

Exelixis Clinical Site #77, São Paulo

04014-002

Exelixis Clinical Site #67, São Paulo

05403 900

Exelixis Clinical Site #98, São Paulo

10 10034

Exelixis Clinical Site #151, Prague

09 38043

Exelixis Clinical Site #141, Grenoble

0168

Exelixis Clinical Site #78, Rome

97 300

Exelixis Clinical Site #89, Piotrków

44 102

Exelixis Clinical Site #139, Gliwice

87 100

Exelixis Clinical Site #162, Torun

030463

Exelixis Clinical Site #160, Bucharest

04191

Exelixis Clinical Site #23, Košice

01207

Exelixis Clinical Site #121, Žilina

08025

Exelixis Clinical Site #115, Barcelona

SW36JJ

Exelixis Clinical Site #135, London

RM7 0AG

Exelixis Clinical Site #84, Romford

M20 4BX

Exelixis Clinical Site #138, Manchester

SM2 5PT

Exelixis Clinical Site #133, Sutton

TQ2 7AA

Exelixis Clinical Site #161, Torquay

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Exelixis

INDUSTRY