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ACTIVE NOT RECRUITING

NCT06082167

PHASE2/PHASE3

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

Sponsor: Exelixis

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with programmed death-ligand 1 (PD-L1) positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have not received prior systemic therapy for recurrent or metastatic disease.

Official title: A Phase 2/3, Randomized, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2024-06-07

Completion Date

2029-03

Last Updated

2025-08-17

Healthy Volunteers

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

Inclusion Criteria: * Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy. * Should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to randomization if given as part of multimodal treatment for locally advanced disease is allowed. * The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, and larynx. * PD-L1 expression level Combined Positive Score (CPS) ≥ 1. * Participants with oropharyngeal cancer must have human papillomavirus (HPV) status from tumor tissue. * Measurable disease according to RECIST 1.1 as determined by the Investigator. * Tumor samples (archival or fresh tumor biopsy) are required. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization. * Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. * Age 18 years (or the legal age of consent in your country, if higher than 18) or older on the day of consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Adequate organ and marrow function. Exclusion Criteria: * Nasopharynx, salivary gland or occult primary site (regardless of p16 status). * Has disease that is suitable for local therapy administered with curative intent. * Has received prior therapy with zanzalintinib, any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (for example, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137). * Life expectancy \< 3 months. * Had progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC. * Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks prior to randomization. * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to randomization. * Positive hepatitis B surface antigen (HBsAg) test. * Positive hepatitis C virus (HCV) antibody test. * Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Complete wound healing from major or minor surgery must have occurred at least prior to randomization. * Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms per electrocardiogram (ECG) within 28 days before randomization. * Pregnant or lactating females. * Administration of a live, attenuated vaccine within 30 days before randomization.

Locations (168)

Exelixis Clinical Site #2

Fullerton, California, United States

Exelixis Clinical Site #1

Orange City, Florida, United States

Exelixis Clinical Site #163

Tampa, Florida, United States

Exelixis Clinical Site #123

Athens, Georgia, United States

Exelixis Clinical Site #82

Atlanta, Georgia, United States

Exelixis Clinical Site #19

Chicago, Illinois, United States

Exelixis Clinical Site #62

Des Moines, Iowa, United States

Exelixis Clinical Site #100

Iowa City, Iowa, United States

Exelixis Clinical Site #4

St Louis, Missouri, United States

Exelixis Clinical Site #148

Lebanon, New Hampshire, United States

Exelixis Clinical Site #158

Camden, New Jersey, United States

Exelixis Clinical Site #3

Shirley, New York, United States

Exelixis Clinical Site #95

Durham, North Carolina, United States

Exelixis Clinical Site #117

Wilson, North Carolina, United States

Exelixis Clinical Site #43

Roanoke, Virginia, United States

Exelixis Clinical Site #73

Rosario, Santa Fe Province, Argentina

Exelixis Clinical Site #91

Buenos Aires, Argentina

Exelixis Clinical Site # 47

Ciudad Autonoma de Buenos Aire, Argentina

Exelixis Clinical Site #53

Ciudad Autonoma de Buenos Aire, Argentina

Exelixis Clinical Site #93

Córdoba, Argentina

Exelixis Clinical Site #64

Córdoba, Argentina

Exelixis Clinical Site #157

Pergamino, Argentina

Exelixis Clinical Site #92

Santa Fe, Argentina

Exelixis Clinical Site #57

Port Macquarie, New South Wales, Australia

Exelixis Clinical Site # 46

Adelaide, Australia

Exelixis Clinical Site #154

Bedford Park, Australia

Exelixis Clinical Site #137

Camperdown, Australia

Exelixis Clinical Site #39

Murdoch, Australia

Exelixis Clinical Site #156

Linz, Austria

Exelixis Clinical Site #42

Salzburg, Austria

Exelixis Clinical Site #166

Vienna, Austria

Exelixis Clinical Site #22

Brussels, Belgium

Exelixis Clinical Site #106

Charleroi, Belgium

Exelixis Clinical Site #14

Libramont, Belgium

Exelixis Clinical Site #37

Sint-Niklaas, Belgium

Exelixis Clinical Site #68

Passo Fundo, Rio Grande do Sul, Brazil

Exelixis Clinical Site #90

Porto Alegre, Rio Grande do Sul, Brazil

Exelixis Clinical Site #110

Jaú, São Paulo, Brazil

Exelixis Clinical Site #65

Santo André, São Paulo, Brazil

Exelixis Clinical Site #83

São José do Rio Preto, São Paulo, Brazil

Exelixis Clinical Site #116

Barretos, Brazil

Exelixis Clinical Site #75

Curitiba, Brazil

Exelixis Clinical Site #101

Curitiba, Brazil

Exelixis Clinical Site #97

Porto Alegre, Brazil

Exelixis Clinical Site #102

Recife, Brazil

Exelixis Clinical Site #87

Rio de Janeiro, Brazil

Exelixis Clinical Site #76

São Paulo, Brazil

Exelixis Clinical Site #77

São Paulo, Brazil

Exelixis Clinical Site #67

São Paulo, Brazil

Exelixis Clinical Site #98

São Paulo, Brazil

Exelixis Clinical Site #88

São Paulo, Brazil

Exelixis Clinical Site #25

Plovdiv, Bulgaria

Exelixis Clinical Site #94

Rousse, Bulgaria

Exelixis Clinical Site #15

Sofia, Bulgaria

Exelixis Clinical Site #11

Sofia, Bulgaria

Exelixis Clinical Site #54

Sofia, Bulgaria

Exelixis Clinical Site #33

Santiago, Chile

Exelixis Clinical Site #52

Santiago, Chile

Exelixis Clinical Site #38

Santiago, Chile

Exelixis Clinical Site #109

Santiago, Chile

Exelixis Clinical Site #50

Talca, Chile

Exelixis Clinical Site #51

Valdivia, Chile

Exelixis Clinical Site #40

Viña del Mar, Chile

Exelixis Clinical Site #96

Barranquilla, Colombia

Exelixis Clinical Site #152

Bogotá, Colombia

Exelixis Clinical Site #103

Floridablanca, Colombia

Exelixis Clinical Site #146

Pasto, Colombia

Exelixis Clinical Site #149

Pereira, Colombia

Exelixis Clinical Site #49

Nový Jičín, Czechia

Exelixis Clinical Site #58

Olomouc, Czechia

Exelixis Clinical Site #151

Prague, Czechia

Exelixis Clinical Site #34

Prague, Czechia

Exelixis Clinical Site #48

Prague, Czechia

Exelixis Clinical Site #36

Prague, Czechia

Exelixis Clinical Site #28

Marseille, Bouches-du-Rhône, France

Exelixis Clinical Site #16

Bordeaux, Gironde, France

Exelixis Clinical Site #44

Rennes, Ille Et Vilaine, France

Exelixis Clinical Site #108

Saint Priest En Jarez, Pays de la Loire Region, France

Exelixis Clinical Site #70

Lyon, Rhone, France

Exelixis Clinical Site #107

Le Mans, Sarthe, France

Exelixis Clinical Site #66

Villejuif, Val De Marne, France

Exelixis Clinical Site #144

Dijon, France

Exelixis Clinical Site #141

Grenoble, France

Exelixis Clinical Site #140

Lille, France

Exelixis Clinical Site #26

Paris, France

Exelixis Clinical Site #112

Pierre-Bénite, France

Exelixis Clinical Site #105

Poitiers, France

Exelixis Clinical Site #167

Giessen, Germany

Exelixis Clinical Site #155

Athens, Greece

Exelixis Clinical Site #129

Athens, Greece

Exelixis Clinical Site #159

Larissa, Greece

Exelixis Clinical Site #120

Thessaloniki, Greece

Exelixis Clinical Site #150

Thessaloniki, Greece

Exelixis Clinical Site #128

Thessaloniki, Greece

Exelixis Clinical Site #125

Budapest, Hungary

Exelixis Clinical Site #99

Kecskemét, Hungary

Exelixis Clinical Site #131

Salgótarján, Hungary

Exelixis Clinical Site #147

Szekszárd, Hungary

Exelixis Clinical Site #132

Haifa, Israel

Exelixis Clinical Site #85

Haifa, Israel

Exelixis Clinical Site #74

Jerusalem, Israel

Exelixis Clinical Site #122

Ramat Gan, Israel

Exelixis Clinical Site #86

Tel Aviv, Israel

Exelixis Clinical Site #21

Candiolo, Torino, Italy

Exelixis Clinical Site #35

Brescia, Italy

Exelixis Clinical Site #45

Catania, Italy

Exelixis Clinical Site #81

Milan, Italy

Exelixis Clinical Site #55

Milan, Italy

Exelixis Clinical Site #18

Naples, Italy

Exelixis Clinical Site #78

Rome, Italy

Exelixis Clinical Site #124

Rozzano, Italy

Exelixis Clinical Site #10

Verona, Italy

Exelixis Clinical Site #61

Putrajaya, Kuala Lumpur, Malaysia

Exelixis Clinical Site #60

Kuala Lumpur, Malaysia

Exelixis Clinical Site #72

Kuala Lumpur, Malaysia

Exelixis Clinical Site #114

Guadalajara, Jalisco, Mexico

Exelixis Clinical Site #119

San Juan del Río, Querétaro, Mexico

Exelixis Clinical Site #168

Guadalajara, Mexico

Exelixis Clinical Site #89

Piotrków, Trybunalski, Poland

Exelixis Clinical Site #139

Gliwice, Poland

Exelixis Clinical Site #162

Torun, Poland

Exelixis Clinical Site #160

Bucharest, Romania

Exelixis Clinical Site #24

Cluj-Napoca, Romania

Exelixis Clinical Site #20

Craiova, Romania

Exelixis Clinical Site #104

Floreşti, Romania

Exelixis Clinical Site #127

Ploieşti, Romania

Exelixis Clinical Site #143

Timișoara, Romania

Exelixis Clinical Site #23

Košice, Slovakia

Exelixis Clinical Site #27

Trnava, Slovakia

Exelixis Clinical Site #121

Žilina, Slovakia

Exelixis Clinical Site #7

Busan, Gangwon-do, South Korea

Exelixis Clinical Site #30

Suwon, Gyeonggi-do, South Korea

Exelixis Clinical Site #17

Suwon, Gyeonggi-do, South Korea

Exelixis Clinical Site #9

Yangsan, Gyeongsangnam-do, South Korea

Exelixis Clinical Site #69

Jeonju, Jeollabuk-do, South Korea

Exelixis Clinical Site #8

Jeonju, Jeollabuk-do, South Korea

Exelixis Clinical Site #13

Busan, South Korea

Exelixis Clinical Site #5

Seoul, South Korea

Exelixis Clinical Site #63

Seoul, South Korea

Exelixis Clinical Site #12

Seoul, South Korea

Exelixis Clinical Site #6

Seoul, South Korea

Exelixis Clinical Site #29

Seoul, South Korea

Exelixis Clinical Site #130

A Coruña, Spain

Exelixis Clinical Site #115

Barcelona, Spain

Exelixis Clinical Site #113

Girona, Spain

Exelixis Clinical Site #134

Madrid, Spain

Exelixis Clinical Site #111

Madrid, Spain

Exelixis Clinical Site #32

Madrid, Spain

Exelixis Clinical Site #59

Madrid, Spain

Exelixis Clinical Site #31

Madrid, Spain

Exelixis Clinical Site #136

Pamplona, Spain

Exelixis Clinical Site #126

Seville, Spain

Exelixis Clinical Site #153

Valencia, Spain

Exelixis Clinical Site #41

Zaragoza, Spain

Exelixis Clinical Site #145

Kaohsiung City, Taiwan

Exelixis Clinical Site #164

Taichung, Taiwan

Exelixis Clinical Site #118

Taipei, Taiwan

Exelixis Clinical Site #142

Taipei, Taiwan

Exelixis Clinical Site #165

Taoyuan District, Taiwan

Exelixis Clinical Site #71

Bangkoknoi, Bangkok, Thailand

Exelixis Clinical Site #79

Hat Yai, Changwat Songkhla, Thailand

Exelixis Clinical Site #56

Chiang Mai, Chiang Mai, Thailand

Exelixis Clinical Site #80

Bangkok, Thailand

Exelixis Clinical Site #135

London, England, United Kingdom

Exelixis Clinical Site #84

Romford, Essex, United Kingdom

Exelixis Clinical Site #138

Manchester, United Kingdom

Exelixis Clinical Site #133

Sutton, United Kingdom

Exelixis Clinical Site #161

Torquay, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (168)