History of Changes for Study: NCT05425940

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

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Study Record Versions

Version	Submitted Date	Changes
1	June 16, 2022	None (earliest Version on record)
2	June 21, 2022	Outcome Measures, Eligibility, Study Description, Sponsor/Collaborators and Study Status
3	July 26, 2022	Study Status
4	August 26, 2022	Contacts/Locations and Study Status
5	September 9, 2022	Study Status
6	September 13, 2022	Contacts/Locations and Study Status
7	October 14, 2022	Study Status and Contacts/Locations
8	December 16, 2022	Study Status and Contacts/Locations
9	January 4, 2023	Study Status and Contacts/Locations
10	March 23, 2023	Contacts/Locations and Study Status
11	April 4, 2023	Study Status and Contacts/Locations
12	April 24, 2023	Contacts/Locations and Study Status
13	May 2, 2023	Study Status and Contacts/Locations
14	June 5, 2023	Contacts/Locations, Outcome Measures and Study Status
15	June 14, 2023	Contacts/Locations and Study Status
16	June 26, 2023	Contacts/Locations and Study Status
17	July 10, 2023	Study Status and Contacts/Locations
18	August 2, 2023	Study Status and Contacts/Locations
19	August 18, 2023	Contacts/Locations and Study Status
20	September 17, 2023	Study Status and Contacts/Locations
21	October 9, 2023	Contacts/Locations and Study Status
22	October 16, 2023	Contacts/Locations and Study Status
23	October 24, 2023	Contacts/Locations and Study Status
24	January 18, 2024	Outcome Measures, Contacts/Locations, Study Status, Eligibility, Study Design and Study Description
25	March 6, 2024	Contacts/Locations and Study Status
26	March 18, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	XL092-303
Brief Title:	Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer (STELLAR-303)
Official Title:	A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
Secondary IDs:	2021-003243-21 [EudraCT Number]

Study Status


Record Verification:	June 2022
Overall Status:	Recruiting
Study Start:	June 2022
Primary Completion:	August 2025 [Anticipated]
Study Completion:	February 2026 [Anticipated]

First Submitted:	June 16, 2022
First Submitted that Met QC Criteria:	June 16, 2022
First Posted:	June 21, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	June 16, 2022
Last Update Posted:	June 21, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Exelixis
Responsible Party:	Sponsor
Collaborators:	Roche Pharma AG

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description


Brief Summary:	This is a multicenter, randomized, open-label, controlled Phase 3 trial of XL092 + atezolizumab vs regorafenib in subjects with MSS/MSI-low mCRC who have progressed after or are intolerant to standard-of-care (SOC) therapy.
Detailed Description:

Conditions


Conditions:	Colorectal Cancer
Keywords:	Colorectal Cancer

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	600 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Experimental Arm Subjects with mCRC will receive XL092 + atezolizumab	Drug: XL092 Supplied as tablets; administered orally daily Drug: Atezolizumab Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once in a 3-week cycle (q3w) Other Names: Tecentriq®
Active Comparator: Control Arm Subjects with mCRC will receive active comparator of regorafenib	Drug: Regorafenib Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle Other Names: Stivarga®

Outcome Measures


Primary Outcome Measures:
1.	Duration of Overall Survival (OS) [ Time Frame: Approximately 26 months after the first subject is randomized ] Defined as the time from randomization to death due to any cause
Other Outcome Measures:
1.	Duration of Progression-Free Survival (PFS) as assessed by the Investigator per RECIST 1.1 [ Time Frame: Collected at selected time points (eg, 6 months and 12 months) ] Defined as the time randomization to the earlier of either radiographic PD as assessed by the Investigator per RECIST 1.1 or death from any cause
2.	Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1 [ Time Frame: Up to 36 months after the first subject is randomized ] Defined as the proportion of subjects experiencing a confirmed complete response (CR) or confirmed partial response (PR) per as assessed by the Investigator RECIST 1.1 criteria
3.	Duration of Response (DOR) as assessed by the Investigator per RECIST 1.1 [ Time Frame: Up to 36 months after the first subject is randomized ] Defined as the time from the first documentation of objective response (subsequently confirmed at a visit ≥ 28 days later) to disease progression or death due to any cause

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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. Radiographic progression during treatment with or within 3 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 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. 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. Concomitant anticoagulation with oral anticoagulants and platelet inhibitors. Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms within 10 days before randomization. Pregnant or lactating females. Administration of a live, attenuated vaccine within 30 days before randomization.

Contacts/Locations


Central Contact Person:	Exelixis Clinical Trials Telephone: 1-888-EXELIXIS (888-393-5494) Email: druginfo@exelixis.com
Central Contact Backup:	Backup or International Telephone: 650-837-7400
Locations:	United States, Nebraska
	Exelixis Clinical Site #1 [Recruiting] Omaha, Nebraska, United States, 68130

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: