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Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer (STELLAR-303)

Program Status

Active, not recruiting

Phase

Phase 3

Prior Immunotherapy Allowed

CRC-directed Trial

Yes

Drugs

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody, Regorafenib, XL092, Stivarga, Tecentriq

Tags

MSS/ MMRp

Comments

Phase III trial (STELLAR-003), only for MSS CRC patients.
Immunotherapy combination vs standard of care (SOC).
Immunotherapy arm: XL092 (tyrosine kinase inhibitor (TKI)) in combination with atezolizumab (anti PD-L1, checkpoint inhibitor, immunotherapy)
Standard of care arm: regorafenib (Stivarga)
Key inclusion criteria: no prior Stivarga, Lonsurf, or anti PD-L1/PD-1 immunotherapies.
Measurable disease.
Prior trials of the TKI XL092 (alone or in combinations) (STELLAR-001, STELLAR-002) show that is active and safe. Prior trials of other TKI (cabozantinib) plus immunotherapies (COSMIC-021, CAMILLA) showed meaningful activity in mCRC.
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Helpful Links

Location	Location Status
United States
Exelixis Clinical Site #65 Jonesboro, Alabama 72401	Active, not recruiting
Exelixis Clinical Site #30 Phoenix, Arizona 85004	Active, not recruiting
Exelixis Clinical Site #70 Tucson, Arizona 85719	Active, not recruiting
Exelixis Clinical Site #9 Duarte, California 91010	Active, not recruiting
Exelixis Clinical Site #55 La Jolla, California 92037	Active, not recruiting
Exelixis Clinical Site #77 Los Angeles, California 90095	Active, not recruiting
Exelixis Clinical Site #105 Orange, California 92868	Active, not recruiting
Exelixis Clinical Site #80 Santa Monica, California 90404	Active, not recruiting
Exelixis Clinical Site #5 Santa Rosa, California 95403	Active, not recruiting
Exelixis Clinical Site #82 Sylmar, California 91342	Active, not recruiting
Exelixis Clinical Site #58 Torrance, California 90505	Active, not recruiting
Exelixis Clinical Site #81 Whittier, California 90602	Active, not recruiting
Exelixis Clinical Site #125 New Haven, Connecticut 06510	Active, not recruiting
Exelixis Clinical Site #16 Miami Beach, Florida 33140	Active, not recruiting
Exelixis Clinical Site #60 Orlando, Florida 32804	Active, not recruiting
Exelixis Clinical Site #4 Marietta, Georgia 30060	Active, not recruiting
Exelixis Clinical Site #3 Joliet, Illinois 60435	Active, not recruiting
Exelixis Clinical Site #102 Indianapolis, Indiana 46250	Active, not recruiting
Exelixis Clinical Site #10 Westwood, Kansas 66205	Active, not recruiting
Exelixis Clinical Site #47 Lexington, Kentucky 40536	Active, not recruiting
Exelixis Clinical Site #7 New Orleans, Louisiana 70112	Active, not recruiting
Exelixis Clinical Site #22 Saint Louis, Missouri 63141	Active, not recruiting
Exelixis Clinical Site #8 Billings, Montana 59102	Active, not recruiting
Exelixis Clinical Site #1 Omaha, Nebraska 68130	Active, not recruiting
Exelixis Clinical Site #15 Albuquerque, New Mexico 87131	Active, not recruiting
Exelixis Clinical Site #17 Bronx, New York 10461	Active, not recruiting
Exelixis Clinical Site #11 New York, New York 10016	Active, not recruiting
Exelixis Clinical Site #59 New York, New York 10029	Active, not recruiting
Exelixis Clinical Site #74 Charlotte, North Carolina 28204	Active, not recruiting
Exelixis Clinical Site #6 Cincinnati, Ohio 45219	Active, not recruiting
Exelixis Clinical Site #12 Oklahoma City, Oklahoma 73142	Active, not recruiting
Exelixis Clinical Site #75 Portland, Oregon 97210	Active, not recruiting
Exelixis Clinical Site #106 Philadelphia, Pennsylvania 19107	Active, not recruiting
Exelixis Clinical Site #18 Pittsburgh, Pennsylvania 15212	Active, not recruiting
Exelixis Clinical Site #103 Pittsburgh, Pennsylvania 15232	Active, not recruiting
Exelixis Clinical Site #24 Greenville, South Carolina 29607	Active, not recruiting
Exelixis Clinical Site #56 Chattanooga, Tennessee 37404	Active, not recruiting
Exelixis Clinical Site #76 Nashville, Tennessee 37203	Active, not recruiting
Exelixis Clinical Site #133 Nashville, Tennessee 37232	Active, not recruiting
Exelixis Clinical Site #450 Fairfax, Virginia 22031	Active, not recruiting
Exelixis Clinical Site #14 Roanoke, Virginia 24014	Active, not recruiting
Exelixis Clinical Site #13 Seattle, Washington 98101	Active, not recruiting
Exelixis Clinical Site #32 Seattle, Washington 98104	Active, not recruiting
Exelixis Clinical Site #89 Seattle, Washington 98109	Active, not recruiting
Exelixis Clinical Site #2 Spokane, Washington 99208	Active, not recruiting
Australia
Exelixis Clinical Site #83 Albury 2640	Active, not recruiting
Exelixis Clinical Site #53 Bankstown 2200	Active, not recruiting
Exelixis Clinical Site #117 Bedford Park 5042	Active, not recruiting
Exelixis Clinical Site #97 Heidelberg 3084	Active, not recruiting
Exelixis Clinical Site #19 Melbourne 3002	Active, not recruiting
Exelixis Clinical Site #23 Melbourne 3021	Active, not recruiting
Exelixis Clinical Site #27 Port Macquarie 2444	Active, not recruiting
Exelixis Clinical Site #64 Woodville South 5011	Active, not recruiting
Belgium
Exelixis Clinical Site #43 Antwerp 2300	Active, not recruiting
Exelixis Clinical Site #51 Brussels 1200	Active, not recruiting
Exelixis Clinical Site #35 Namur 5000	Active, not recruiting
France
Exelixis Clinical Site #52 Besançon 25030	Active, not recruiting
Exelixis Clinical Site #84 Dijon 21079	Active, not recruiting
Exelixis Clinical Site #88 Herbault 34298	Active, not recruiting
Exelixis Clinical Site #71 Lyon 69008	Active, not recruiting
Exelixis Clinical Site #87 Marseille 13385	Active, not recruiting
Exelixis Clinical Site #38 Paris 75020	Active, not recruiting
Exelixis Clinical Site #93 Suresnes 92150	Active, not recruiting
Germany
Exelixis Clinical Site #127 Hannover, Niedersach 30625	Active, not recruiting
Exelixis Clinical Site #109 Dresden 01307	Active, not recruiting
Exelixis Clinical Site #113 Frankfurt am Main 60488	Active, not recruiting
Exelixis Clinical Site #61 Hamburg 20249	Active, not recruiting
Exelixis Clinical Site #63 Hamburg 22763	Active, not recruiting
Exelixis Clinical Site #91 München 81737	Active, not recruiting
Hong Kong
Exelixis Clinical Site #25 Hong Kong	Active, not recruiting
Exelixis Clinical Site #33 Hong Kong	Active, not recruiting
Hungary
Exelixis Clinical Site #128 Nyíregyháza, Szabolcs-Szatmar-Bereg County 4400	Active, not recruiting
Exelixis Clinical Site #41 Budapest 1097	Active, not recruiting
Exelixis Clinical Site #129 Budapest 1122	Active, not recruiting
Exelixis Clinical Site #48 Debrecen 4302	Active, not recruiting
Exelixis Clinical Site #122 Győr 9024	Active, not recruiting
Korea, Republic of
Exelixis Clinical Site #36 Goyang-si 10408	Active, not recruiting
Exelixis Clinical Site #29 Gyeonggi-do 14068	Active, not recruiting
Exelixis Clinical Site #28 Hwasun 58128	Active, not recruiting
Exelixis Clinical Site #37 Seongnam-si 13620	Active, not recruiting
Exelixis Clinical Site #34 Seoul 03080	Active, not recruiting
Exelixis Clinical Site #45 Seoul 03722	Active, not recruiting
Exelixis Clinical Site #66 Seoul 05505	Active, not recruiting
Exelixis Clinical Site #46 Seoul 06351	Active, not recruiting
Exelixis Clinical Site #54 Seoul 06591	Active, not recruiting
Exelixis Clinical Site #44 Seoul 08308	Active, not recruiting
Exelixis Clinical Site #40 Seoul	Active, not recruiting
New Zealand
Exelixis Clinical Site #57 Auckland 1023	Active, not recruiting
Exelixis Clinical Site #49 Dunedin 9016	Active, not recruiting
Exelixis Clinical Site #69 Hamilton 3204	Active, not recruiting
Exelixis Clinical Site #104 Wellington 6021	Active, not recruiting
Poland
Exelixis Clinical Site #20 Bydgoszcz 85-796	Active, not recruiting
Exelixis Clinical Site #68 Opole 45-061	Active, not recruiting
Exelixis Clinical Site #26 Siedlce 08-110	Active, not recruiting
Exelixis Clinical Site #42 Tomaszów Mazowiecki 97-200	Active, not recruiting
Exelixis Clinical Site #31 Warszawa 02-507	Active, not recruiting
Portugal
Exelixis Clinical Site #108 Almada 2805-267	Active, not recruiting
Exelixis Clinical Site #120 Coimbra 3000-075	Active, not recruiting
Exelixis Clinical Site #99 Guimarães 4835-044	Active, not recruiting
Exelixis Clinical Site #131 Lisboa 1500-650	Active, not recruiting
Exelixis Clinical Site #124 Lisboa 1649-035	Active, not recruiting
Exelixis Clinical Site #96 Lisboa 400-038	Active, not recruiting
Singapore
Exelixis Clinical Site #132 Singapore 119228	Active, not recruiting
Exelixis Clinical Site #100 Singapore 168583	Active, not recruiting
Exelixis Clinical Site #39 Singapore 217562	Active, not recruiting
Exelixis Clinical Site #98 Singapore 258499	Active, not recruiting
Exelixis Clinical Site #94 Singapore 329563	Active, not recruiting
Spain
Exelixis Clinical Site #78 Barcelona 08023	Active, not recruiting
Exelixis Clinical Site #21 Barcelona 08025	Active, not recruiting
Exelixis Clinical Site #86 Barcelona 08035	Active, not recruiting
Exelixis Clinical Site #112 Barcelona 08908	Active, not recruiting
Exelixis Clinical Site #95 Lleida 25198	Active, not recruiting
Exelixis Clinical Site #116 Madrid 28007	Active, not recruiting
Exelixis Clinical Site #72 Madrid 28034	Active, not recruiting
Exelixis Clinical Site #67 Madrid 28041	Active, not recruiting
Exelixis Clinical Site #79 Madrid 28050	Active, not recruiting
Exelixis Clinical Site #90 Valencia 46014	Active, not recruiting
Exelixis Clinical Site #121 Zaragoza 50009	Active, not recruiting
Taiwan
Exelixis Clinical Site #119 Guishan 333	Active, not recruiting
Exelixis Clinical Site #85 Kaohsiung 807	Active, not recruiting
Exelixis Clinical Site #107 Kaohsiung 833	Active, not recruiting
Exelixis Clinical Site #118 Liuying 73657	Active, not recruiting
Exelixis Clinical Site #73 Taichung 40447	Active, not recruiting
Exelixis Clinical Site #101 Tainan 704	Active, not recruiting
Thailand
Exelixis Clinical Site #62 Chiang Mai 50200	Active, not recruiting
Exelixis Clinical Site #92 Hat Yai 90110	Active, not recruiting
United Kingdom
Exelixis Clinical Site #130 Bristol, England BS2 8ED	Active, not recruiting
Exelixis Clinical Site #110 Birmingham B95SS	Active, not recruiting
Exelixis Clinical Site #111 Edinburgh EH42XU	Active, not recruiting
Exelixis Clinical Site #123 London EC1A 7BE	Active, not recruiting
Exelixis Clinical Site #114 London W1G 6AD	Active, not recruiting
Exelixis Clinical Site #115 Romford RM70AG	Active, not recruiting
Exelixis Clinical Site #126 Sutton SM2 5PT	Active, not recruiting

Inclusion Criteria

Inclusion Criteria:

* 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.

Exclusion Criteria

Exclusion Criteria:

* 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

Date Trial Added

2022-06-21

Updated Date

2024-07-05