Trial record 1 of 1 for:
XL092-303 (STELLAR)
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer (STELLAR-303)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05425940 |
|
Recruitment Status :
Recruiting
First Posted : June 21, 2022
Last Update Posted : March 19, 2024
|
Sponsor:
Exelixis
Information provided by (Responsible Party):
Exelixis
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
This is a multicenter, randomized, open-label, controlled Phase 3 trial of XL092 + atezolizumab vs regorafenib in subjects 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer | Drug: XL092 Drug: Atezolizumab Drug: Regorafenib | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 874 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer |
| Actual Study Start Date : | September 7, 2022 |
| Estimated Primary Completion Date : | August 2025 |
| Estimated Study Completion Date : | February 2026 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
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 Name: 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 Name: Stivarga® |
Primary Outcome Measures :
- Overall Survival [ Time Frame: Approximately 32 months after the first subject is randomized. ]
The primary objective of this study is to evaluate OS of XL092 + atezolizumab versus regorafenib in non-liver metastases (NLM) subjects with MSS/MSI-low mCRC who have progressed during, after, or are intolerant to SOC therapy.
Subjects without liver metastases (NLM) are defined as subjects without active liver metastases at screening as determined on baseline imaging of the liver as performed by CT scan with contrast or MRI.
Definitively treated liver metastases (which includes surgical resection, microwave or radiofrequency ablation, or stereotactic body radiation therapy, but not yttrium-90 or chemoembolization alone) that were treated at least 6 months prior to enrollment with no evidence of radiologic progression on subsequent imaging are considered to be non-active liver metastases.
Secondary Outcome Measures :
- Overall Survival [ Time Frame: Approximately 32 months after the first subject is randomized. ]The key secondary objective is to evaluate OS of XL092 + atezolizumab versus regorafenib in all randomized subjects with MSS/MSI-low mCRC who have progressed during, after, or are intolerant to SOC therapy.
Other Outcome Measures:
- Progression-Free Survival (PFS) as assessed by the Investigator per RECIST 1.1 [ Time Frame: Approximately 26 months after the first subject is randomized. ]Defined as the time randomization to the earlier of either radiographic progressive disease (PD) as assessed by the Investigator per RECIST 1.1 or death from any cause.
- 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) as assessed by the Investigator per RECIST 1.1 criteria.
- 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 either radiographic disease progression or death due to any cause.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
- 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:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05425940
Contacts
| Contact: Exelixis Clinical Trials | 1-888-EXELIXIS (888-393-5494) | druginfo@exelixis.com | |
| Contact: Backup or International | 650-837-7400 |
Locations
Show 133 study locations
Sponsors and Collaborators
Exelixis
| Responsible Party: | Exelixis |
| ClinicalTrials.gov Identifier: | NCT05425940 |
| Other Study ID Numbers: |
XL092-303 2021-003243-21 ( EudraCT Number ) |
| First Posted: | June 21, 2022 Key Record Dates |
| Last Update Posted: | March 19, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Exelixis:
|
Colorectal Cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Atezolizumab Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Antineoplastic Agents |