A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Condition(s) studied
Investigational drug(s) / intervention(s)
Inavolisib: Inavolisib will be administered orally as per schedule specified in the respective arms.
Bevacizumab: Bevacizumab IV will be administered as per schedule specified in the respective arm.
Cetuximab: Cetuximab IV will be administered as per schedule specified in the respective arm.
Atezolizumab: Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
Tiragolumab: Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.
SY-5609: SY-5609 will be administered by mouth as per schedule specified in the respective arm.
Divarasib: Divarasib will be administered orally as per schedule specified in the respective arms.
FOLFOX: FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.
FOLFIRI: FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.
FoundationOne®Liquid CDx: FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Study summary
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
Eligibility
Primary outcome measure(s)
- Objective Response Rate — Approximately 84 months
Defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to RECIST v1.1
Trial sites (84)
| Facility | City | Region | Status |
|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | Withdrawn |
| Mayo Clinic Arizona | Phoenix | Arizona | Recruiting |
| City of Hope Comprehensive Cancer Center | Duarte | California | Recruiting |
| cCare | Encinitas | California | Withdrawn |
| USC Norris Cancer Center | Los Angeles | California | Completed |
| Cedars-Sinai Medical Center | Los Angeles | California | Recruiting |
| UCLA | Los Angeles | California | Recruiting |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | Withdrawn |
| Stanford Cancer Center | Stanford | California | Completed |
| University of Colorado Cancer Center | Aurora | Colorado | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Lone Tree | Colorado | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| Eastern Ct Hema/Onco Assoc | Norwich | Connecticut | Withdrawn |
| Mayo Clinic in Florida | Jacksonville | Florida | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| Illinois Cancer Specialists | Arlington Heights | Illinois | Recruiting |
| Mary Bird Perkins Cancer Ctr | Baton Rouge | Louisiana | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Completed |
| Karmanos Cancer Institute | Detroit | Michigan | Withdrawn |
| Mayo Clinic Rochester | Rochester | Minnesota | Recruiting |
| New York Cancer & Blood Specialists - New Hyde Park | New Hyde Park | New York | Recruiting |
| New York Cancer and Blood Specialists-Central Park Hematology & Oncology | New York | New York | Recruiting |
| New York Cancer & Blood Specialists | Port Jefferson Station | New York | Recruiting |
| New York Cancer & Blood Specialists - Bronx | The Bronx | New York | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Completed |
| Hematology Oncology Salem | Salem | Oregon | Recruiting |
| UPMC - Hillman Cancer Center | Pittsburgh | Pennsylvania | Active Not Recruiting |
| Sarah Cannon Research Institute / Tennessee Oncology | Nashville | Tennessee | Completed |
| SCRI Oncology Partners | Nashville | Tennessee | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Completed |
| Texas Oncology - Northeast Texas | Denton | Texas | Recruiting |
| Lumi Research | Kingwood | Texas | Withdrawn |
| Texas Oncology - Gulf Coast | Webster | Texas | Recruiting |
| Swedish Cancer Inst. | Seattle | Washington | Completed |
| Medical Oncology Associates | Spokane | Washington | Withdrawn |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | Recruiting |
| Princess Margaret Cancer Center | Toronto | Ontario | Active Not Recruiting |
| Jewish General Hospital | Montreal | Quebec | Withdrawn |
| McGill University Health Center | Montreal | Quebec | Withdrawn |
| Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed | Herlev | Denmark | Recruiting |
+ 44 more sites — see the full list on the official registry below.
More Hoffmann-La Roche trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04929223 on ClinicalTrials.gov ↗ ← All trials in South Korea