copia de flecha Creado con Sketch. Logotipo de FightCRC fcc-logo-light
Estudio de XL092 + Atezolizumab frente a Regorafenib en sujetos con cáncer colorrectal metastásico (STELLAR-303)

Estado del programa

ACTIVE_NOT_RECRUITING

Fase

PHASE3

Ensayo centrado en la inmunoterapia

No

Inmunoterapia previa permitida

No

Ensayo dirigido por el CRC

Drogas

Atezolizumab (MPDL3280A), un anticuerpo anti-PD-L1 de ingeniería, Regorafenib, XL092, Stivarga, Tecentriq

Etiquetas

MSS/ MMRp

Comentarios

Ensayo de fase III (STELLAR-003), sólo para pacientes con CCR MSS.
Combinación de inmunoterapia frente al tratamiento estándar (SOC).
Brazo de inmunoterapia: XL092 (inhibidor de la tirosina quinasa [TKI]) en combinación con atezolizumab (anti PD-L1, inhibidor de puntos de control, inmunoterapia).
Brazo de tratamiento estándar: regorafenib (Stivarga)
Criterios clave de inclusión: no haber recibido antes Stivarga, Lonsurf o inmunoterapias anti PD-L1/PD-1.
Enfermedad medible.
Ensayos previos del TKI XL092 (solo o en combinaciones) (STELLAR-001, STELLAR-002) muestran que es activo y seguro. Ensayos previos de otro TKI (cabozantinib) más inmunoterapias (COSMIC-021, CAMILLA) mostraron una actividad significativa en el mCRC.
Ver enlaces útiles

Enlaces útiles

Ubicación Situación
Estados Unidos
Centro clínico de Exelixis #65
Jonesboro, Alabama 72401
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #30
Phoenix, Arizona 85004
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #70
Tucson, Arizona 85719
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #9
Duarte, California 91010
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #55
La Jolla, California 92037
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #77
Los Ángeles, California 90095
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #105
Orange, California 92868
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #80
Santa Monica, California 90404
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #5
Santa Rosa, California 95403
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #82
Sylmar, California 91342
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #58
Torrance, California 90505
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #81
Whittier, California 90602
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #125
New Haven, Connecticut 06510
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #16
Miami Beach, Florida 33140
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #60
Orlando, Florida 32804
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #4
Marietta, Georgia 30060
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #3
Joliet, Illinois 60435
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #102
Indianápolis, Indiana 46250
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #10
Westwood, Kansas 66205
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #47
Lexington, Kentucky 40536
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #7
Nueva Orleans, Luisiana 70112
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #22
San Luis, Misuri 63141
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #8
Billings, Montana 59102
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #1
Omaha, Nebraska 68130
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #15
Albuquerque, Nuevo México 87131
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #17
Bronx, Nueva York 10461
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #11
Nueva York, Nueva York 10016
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #59
Nueva York, Nueva York 10029
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #74
Charlotte, Carolina del Norte 28204
ACTIVE_NOT_RECRUITING
Centro clínico Exelixis #6
Cincinnati, Ohio 45219
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #12
Oklahoma City, Oklahoma 73142
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #75
Portland, Oregón 97210
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #106
Filadelfia, Pensilvania 19107
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #18
Pittsburgh, Pensilvania 15212
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #103
Pittsburgh, Pensilvania 15232
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #24
Greenville, Carolina del Sur 29607
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #56
Chattanooga, Tennessee 37404
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #76
Nashville, Tennessee 37203
ACTIVE_NOT_RECRUITING
Exelixis Clinical Site #133
Nashville, Tennessee 37232
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #450
Fairfax, Virginia 22031
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #14
Roanoke, Virginia 24014
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #13
Seattle, Washington 98101
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #32
Seattle, Washington 98104
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #89
Seattle, Washington 98109
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #2
Spokane, Washington 99208
ACTIVE_NOT_RECRUITING
Australia
Sitio clínico de Exelixis #83
Albury 2640
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #53
Bankstown 2200
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #117
Parque Bedford 5042
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #97
Heidelberg 3084
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #19
Melbourne 3002
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #23
Melbourne 3021
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #27
Puerto Macquarie 2444
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #64
Woodville Sur 5011
ACTIVE_NOT_RECRUITING
Bélgica
Centro clínico de Exelixis #43
Amberes 2300
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #51
Bruselas 1200
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #35
Namur 5000
ACTIVE_NOT_RECRUITING
Francia
Centro clínico de Exelixis #52
Besançon 25030
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #84
Dijon 21079
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #88
Herbault 34298
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #71
Lyon 69008
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #87
Marsella 13385
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #38
París 75020
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #93
Suresnes 92150
ACTIVE_NOT_RECRUITING
Alemania
Exelixis Clinical Site #127
Hannover, Niedersach 30625
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #109
Dresde 01307
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #113
Fráncfort del Meno 60488
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #61
Hamburgo 20249
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #63
Hamburgo 22763
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #91
Múnich 81737
ACTIVE_NOT_RECRUITING
Hong Kong
Centro clínico de Exelixis #25
Hong Kong
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #33
Hong Kong
ACTIVE_NOT_RECRUITING
Hungría
Exelixis Clinical Site #128
Nyíregyháza, Szabolcs-Szatmar-Bereg County 4400
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #41
Budapest 1097
ACTIVE_NOT_RECRUITING
Exelixis Clinical Site #129
Budapest 1122
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #48
Debrecen 4302
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #122
Győr 9024
ACTIVE_NOT_RECRUITING
Corea, República de
Centro clínico de Exelixis #36
Goyang-si 10408
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #29
Gyeonggi-do 14068
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #28
Hwasun 58128
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #37
Seongnam-si 13620
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #34
Seúl 03080
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #45
Seúl 03722
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #66
Seúl 05505
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #46
Seúl 06351
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #54
Seúl 06591
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #44
Seúl 08308
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #40
Seúl
ACTIVE_NOT_RECRUITING
Nueva Zelanda
Sitio clínico de Exelixis #57
Auckland 1023
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #49
Dunedin 9016
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #69
Hamilton 3204
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #104
Wellington 6021
ACTIVE_NOT_RECRUITING
Polonia
Sitio clínico de Exelixis #20
Bydgoszcz 85-796
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #68
Opole 45-061
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #26
Siedlce 08-110
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #42
Tomaszów Mazowiecki 97-200
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #31
Varsovia 02-507
ACTIVE_NOT_RECRUITING
Portugal
Centro clínico de Exelixis #108
Almada 2805-267
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #120
Coimbra 3000-075
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #99
Guimarães 4835-044
ACTIVE_NOT_RECRUITING
Exelixis Clinical Site #131
Lisboa 1500-650
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #124
Lisboa 1649-035
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #96
Lisboa 400-038
ACTIVE_NOT_RECRUITING
Singapur
Exelixis Clinical Site #132
Singapur 119228
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #100
Singapur 168583
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #39
Singapur 217562
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #98
Singapur 258499
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #94
Singapur 329563
ACTIVE_NOT_RECRUITING
España
Centro clínico de Exelixis #78
Barcelona 08023
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #21
Barcelona 08025
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #86
Barcelona 08035
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #112
Barcelona 08908
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #95
Lleida 25198
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #116
Madrid 28007
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #72
Madrid 28034
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #67
Madrid 28041
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #79
Madrid 28050
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #90
Valencia 46014
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #121
Zaragoza 50009
ACTIVE_NOT_RECRUITING
Taiwán
Centro clínico de Exelixis #119
Guishan 333
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #85
Kaohsiung 807
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #107
Kaohsiung 833
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #118
Liuying 73657
ACTIVE_NOT_RECRUITING
Sitio clínico de Exelixis #73
Taichung 40447
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #101
Tainan 704
ACTIVE_NOT_RECRUITING
Tailandia
Centro clínico de Exelixis #62
Chiang Mai 50200
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #92
Hat Yai 90110
ACTIVE_NOT_RECRUITING
Reino Unido
Exelixis Clinical Site #130
Bristol, England BS2 8ED
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #110
Birmingham B95SS
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #111
Edimburgo EH42XU
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #123
Londres EC1A 7BE
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #114
Londres W1G 6AD
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #115
Romford RM70AG
ACTIVE_NOT_RECRUITING
Centro clínico de Exelixis #126
Sutton SM2 5PT
ACTIVE_NOT_RECRUITING

Criterios de inclusión

Criterios de inclusión:

* Subjects with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.

* Documented RAS status (mutant or wild-type [WT]), by tissue-based analysis.
* Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis.
* Has received standard-of-care (SOC) anticancer therapies as prior therapy for metastatic CRC and has radiographically progressed, is refractory or intolerant to these therapies.

* Systemic SOC anticancer therapy if approved and available in the country where the subject is randomized.
* Radiographic progression during treatment with or within 4 months following the last dose of the most recent approved SOC chemotherapy regimen.
* Measurable disease according to RECIST v1.1 as determined by the Investigator.
* Available archival tumor biopsy material. 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 older on the day of consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Adequate organ and marrow function.
* Fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and after the last dose of treatment.
* Female subjects of childbearing potential must not be pregnant at screening.

Criterios de exclusión

Criterios de exclusión:

* Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or PD-L1/PD-1 targeting immune checkpoint inhibitors (ICIs).
* Receipt of a small molecule kinase inhibitor (including investigational agents) within 2 weeks before randomization.
* Receipt of any type of anticancer antibody therapy, systemic chemotherapy, or hormonal anti-cancer therapy within 3 weeks (or bevacizumab within 4 weeks) before randomization.
* Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before 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 before randomization.
* Subject has uncontrolled, significant intercurrent or recent illness.
* Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization.
* Systemic treatment with, or any condition requiring, either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization.
* Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms within 10 days before randomization.
* History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.
* Pregnant or lactating females.
* Inability to swallow study treatment formulation, inability to receive IV administration, or presence of GI condition that might affect the absorption of study drug.
* Previously identified allergy or hypersensitivity to components of the study treatment formulations.
* Any other active malignancy or diagnosis of another malignancy within 2 years before randomization. Exceptions are noted in the protocol.
* Administration of a live, attenuated vaccine within 30 days before randomization.

NCT ID

NCT05425940

Fecha en que se añadió el juicio

2022-06-21

Fecha de actualización

2024-07-05