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ACTIVE NOT RECRUITING
NCT05425940
PHASE3

Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer

Sponsor: Exelixis

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to evaluate XL092 + atezolizumab versus regorafenib in participants with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy.

Official title: A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

901

Start Date

2022-09-07

Completion Date

2027-01

Last Updated

2025-10-23

Healthy Volunteers

No

Interventions

DRUG

XL092

Supplied as tablets; administered orally daily.

DRUG

Atezolizumab

Supplied as 1200 milligrams (mg)/20 milliliter (mL) vials; administered as a 1200 mg intravenous (IV) infusion once in a 3-week cycle (q3w).

DRUG

Regorafenib

Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle.

Locations (133)

Exelixis Clinical Site #65

Jonesboro, Alabama, United States

Exelixis Clinical Site #30

Phoenix, Arizona, United States

Exelixis Clinical Site #70

Tucson, Arizona, United States

Exelixis Clinical Site #9

Duarte, California, United States

Exelixis Clinical Site #55

La Jolla, California, United States

Exelixis Clinical Site #77

Los Angeles, California, United States

Exelixis Clinical Site #105

Orange, California, United States

Exelixis Clinical Site #80

Santa Monica, California, United States

Exelixis Clinical Site #5

Santa Rosa, California, United States

Exelixis Clinical Site #82

Sylmar, California, United States

Exelixis Clinical Site #58

Torrance, California, United States

Exelixis Clinical Site #81

Whittier, California, United States

Exelixis Clinical Site #125

New Haven, Connecticut, United States

Exelixis Clinical Site #16

Miami Beach, Florida, United States

Exelixis Clinical Site #60

Orlando, Florida, United States

Exelixis Clinical Site #4

Marietta, Georgia, United States

Exelixis Clinical Site #3

Joliet, Illinois, United States

Exelixis Clinical Site #102

Indianapolis, Indiana, United States

Exelixis Clinical Site #10

Westwood, Kansas, United States

Exelixis Clinical Site #47

Lexington, Kentucky, United States

Exelixis Clinical Site #7

New Orleans, Louisiana, United States

Exelixis Clinical Site #22

St Louis, Missouri, United States

Exelixis Clinical Site #8

Billings, Montana, United States

Exelixis Clinical Site #1

Omaha, Nebraska, United States

Exelixis Clinical Site #15

Albuquerque, New Mexico, United States

Exelixis Clinical Site #11

New York, New York, United States

Exelixis Clinical Site #59

New York, New York, United States

Exelixis Clinical Site #17

The Bronx, New York, United States

Exelixis Clinical Site #74

Charlotte, North Carolina, United States

Exelixis Clinical Site #6

Cincinnati, Ohio, United States

Exelixis Clinical Site #12

Oklahoma City, Oklahoma, United States

Exelixis Clinical Site #75

Portland, Oregon, United States

Exelixis Clinical Site #106

Philadelphia, Pennsylvania, United States

Exelixis Clinical Site #18

Pittsburgh, Pennsylvania, United States

Exelixis Clinical Site #103

Pittsburgh, Pennsylvania, United States

Exelixis Clinical Site #24

Greenville, South Carolina, United States

Exelixis Clinical Site #56

Chattanooga, Tennessee, United States

Exelixis Clinical Site #76

Nashville, Tennessee, United States

Exelixis Clinical Site #133

Nashville, Tennessee, United States

Exelixis Clinical Site #450

Fairfax, Virginia, United States

Exelixis Clinical Site #14

Roanoke, Virginia, United States

Exelixis Clinical Site #13

Seattle, Washington, United States

Exelixis Clinical Site #32

Seattle, Washington, United States

Exelixis Clinical Site #89

Seattle, Washington, United States

Exelixis Clinical Site #2

Spokane, Washington, United States

Exelixis Clinical Site #83

Albury, Australia

Exelixis Clinical Site #53

Bankstown, Australia

Exelixis Clinical Site #117

Bedford Park, Australia

Exelixis Clinical Site #97

Heidelberg, Australia

Exelixis Clinical Site #19

Melbourne, Australia

Exelixis Clinical Site #23

Melbourne, Australia

Exelixis Clinical Site #27

Port Macquarie, Australia

Exelixis Clinical Site #64

Woodville South, Australia

Exelixis Clinical Site #43

Antwerp, Belgium

Exelixis Clinical Site #51

Brussels, Belgium

Exelixis Clinical Site #35

Namur, Belgium

Exelixis Clinical Site #52

Besançon, France

Exelixis Clinical Site #84

Dijon, France

Exelixis Clinical Site #88

Herbault, France

Exelixis Clinical Site #71

Lyon, France

Exelixis Clinical Site #87

Marseille, France

Exelixis Clinical Site #38

Paris, France

Exelixis Clinical Site #93

Suresnes, France

Exelixis Clinical Site #127

Hanover, Niedersach, Germany

Exelixis Clinical Site #109

Dresden, Germany

Exelixis Clinical Site #113

Frankfurt am Main, Germany

Exelixis Clinical Site #61

Hamburg, Germany

Exelixis Clinical Site #63

Hamburg, Germany

Exelixis Clinical Site #91

München, Germany

Exelixis Clinical Site #25

Hong Kong, Hong Kong

Exelixis Clinical Site #33

Hong Kong, Hong Kong

Exelixis Clinical Site #128

Nyíregyháza, Szabolcs-Szatmar-Bereg County, Hungary

Exelixis Clinical Site #41

Budapest, Hungary

Exelixis Clinical Site #129

Budapest, Hungary

Exelixis Clinical Site #48

Debrecen, Hungary

Exelixis Clinical Site #122

Győr, Hungary

Exelixis Clinical Site #57

Auckland, New Zealand

Exelixis Clinical Site #49

Dunedin, New Zealand

Exelixis Clinical Site #69

Hamilton, New Zealand

Exelixis Clinical Site #104

Wellington, New Zealand

Exelixis Clinical Site #20

Bydgoszcz, Poland

Exelixis Clinical Site #68

Opole, Poland

Exelixis Clinical Site #26

Siedlce, Poland

Exelixis Clinical Site #42

Tomaszów Mazowiecki, Poland

Exelixis Clinical Site #31

Warsaw, Poland

Exelixis Clinical Site #108

Almada, Portugal

Exelixis Clinical Site #120

Coimbra, Portugal

Exelixis Clinical Site #99

Guimarães, Portugal

Exelixis Clinical Site #131

Lisbon, Portugal

Exelixis Clinical Site #124

Lisbon, Portugal

Exelixis Clinical Site #96

Lisbon, Portugal

Exelixis Clinical Site #132

Singapore, Singapore

Exelixis Clinical Site #100

Singapore, Singapore

Exelixis Clinical Site #39

Singapore, Singapore

Exelixis Clinical Site #98

Singapore, Singapore

Exelixis Clinical Site #94

Singapore, Singapore

Exelixis Clinical Site #36

Goyang-si, South Korea

Exelixis Clinical Site #29

Gyeonggi-do, South Korea

Exelixis Clinical Site #28

Hwasun, South Korea

Exelixis Clinical Site #37

Seongnam-si, South Korea

Exelixis Clinical Site #34

Seoul, South Korea

Exelixis Clinical Site #45

Seoul, South Korea

Exelixis Clinical Site #66

Seoul, South Korea

Exelixis Clinical Site #46

Seoul, South Korea

Exelixis Clinical Site #54

Seoul, South Korea

Exelixis Clinical Site #44

Seoul, South Korea

Exelixis Clinical Site #40

Seoul, South Korea

Exelixis Clinical Site #78

Barcelona, Spain

Exelixis Clinical Site #21

Barcelona, Spain

Exelixis Clinical Site #86

Barcelona, Spain

Exelixis Clinical Site #112

Barcelona, Spain

Exelixis Clinical Site #95

Lleida, Spain

Exelixis Clinical Site #116

Madrid, Spain

Exelixis Clinical Site #72

Madrid, Spain

Exelixis Clinical Site #67

Madrid, Spain

Exelixis Clinical Site #79

Madrid, Spain

Exelixis Clinical Site #90

Valencia, Spain

Exelixis Clinical Site #121

Zaragoza, Spain

Exelixis Clinical Site #119

Guishan, Taiwan

Exelixis Clinical Site #85

Kaohsiung City, Taiwan

Exelixis Clinical Site #107

Kaohsiung City, Taiwan

Exelixis Clinical Site #118

Liuying, Taiwan

Exelixis Clinical Site #73

Taichung, Taiwan

Exelixis Clinical Site #101

Tainan, Taiwan

Exelixis Clinical Site #62

Chiang Mai, Thailand

Exelixis Clinical Site #92

Hat Yai, Thailand

Exelixis Clinical Site #130

Bristol, England, United Kingdom

Exelixis Clinical Site #110

Birmingham, United Kingdom

Exelixis Clinical Site #111

Edinburgh, United Kingdom

Exelixis Clinical Site #123

London, United Kingdom

Exelixis Clinical Site #114

London, United Kingdom

Exelixis Clinical Site #115

Romford, United Kingdom

Exelixis Clinical Site #126

Sutton, United Kingdom