A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)
AstraZeneca
Summary
The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).
Description
This is a Phase II, platform, open-label, multi-drug, multicenter, global study. This is a modular study, that includes a master protocol and substudies. Partcipants will be randomised to one of the following intervention groups: * Volrustomig + FOLFIRI + bevacizumab group (Arm A) * FOLFIRI + bevacizumab group (Arm B) The substudy will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and bevacizumab only in participants with Mismatch-repair-proficient (pMMR)/Microsatellite stable (MSS) metastatic CRC (mCRC) in…
Eligibility
- Age range
- 18–130 years
- Sex
- All
- Healthy volunteers
- No
Overall Inclusion Criteria: * Histopathologically confirmed colorectal adenocarcinoma. * Provision of FFPE tumor sample collected as per SoC. * Presence of measurable disease by RECIST 1.1 criteria. * ECOG performance status of 0 or 1. * Life expectancy ≥ 12 weeks at the time of screening. Substudy Inclusion Criteria: * No radiological evidence of liver metastasis. * No prior systemic therapy for mCRC, except for neoadjuvant/adjuvant chemotherapy where, \> 6 months have elapsed between completion of therapy and documented date of diagnosis of recurrent or metastatic disease. * Known pMMR/MS…
Interventions
- DrugVolrustomig
Volrustomig will be administered as intravenous (IV) infusion.
- DrugFOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)
FOLFIRI will be administered as IV infusion.
- DrugBevacizumab
Bevacizumab will be administered as IV infusion.
Locations (76)
- Research SiteScottsdale, Arizona
- Research SiteLos Angeles, California
- Research SiteWashington D.C., District of Columbia
- Research SiteChicago, Illinois
- Research SiteBaltimore, Maryland
- Research SiteBoston, Massachusetts