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).
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 the absence of liver metastases and who have not received previous systemic treatment for advanced or metastatic disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Volrustomig will be administered as intravenous (IV) infusion.
FOLFIRI will be administered as IV infusion.
Bevacizumab will be administered as IV infusion.
Progression Free Survival (PFS)
PFS is defined as the time from randomization until progression per Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) or death due to any cause.
Time frame: Approximately 3 years
Number of Participants with Adverse Events (AEs)
Number of participants who received at least one dose of study treatment will be assessed.
Time frame: Approximately 3 years
Overall Survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Time frame: Approximately 3 years
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a confirmed complete response or confirmed partial response as per RECIST 1.1.
Time frame: Approximately 3 years
Disease Control Rate (DCR)
DCR is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1 after randomization.
Time frame: Approximately 3 years
Duration of Response (DOR)
DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 or death due to any cause.
Time frame: Approximately 3 years
Time to second progression or death (PFS2)
PFS2 is defined as the time from randomization to the earliest of the progression event, after first subsequent therapy, or death.
AstraZeneca Clinical Study Information Center
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Research Site
Scottsdale, Arizona, United States
RECRUITINGResearch Site
Los Angeles, California, United States
RECRUITINGResearch Site
Washington D.C., District of Columbia, United States
NOT_YET_RECRUITINGResearch Site
Chicago, Illinois, United States
NOT_YET_RECRUITINGResearch Site
Baltimore, Maryland, United States
RECRUITINGResearch Site
Boston, Massachusetts, United States
COMPLETEDResearch Site
Rochester, Minnesota, United States
RECRUITINGResearch Site
Trenton, New Jersey, United States
NOT_YET_RECRUITINGResearch Site
Rochester, New York, United States
RECRUITINGResearch Site
Cleveland, Ohio, United States
WITHDRAWN...and 66 more locations
Time frame: Approximately 3 years
Maximum Observed Concentration (Cmax)
Concentration of novel study intervention in serum and PK parameters as data allow (such as peak and trough concentrations) will be assessed.
Time frame: Approximately 3 years
Observed lowest concentration before the next dose is administered (Ctrough)
Concentration of novel study intervention in serum and PK parameters as data allow (such as peak and trough concentrations) will be assessed.
Time frame: Approximately 3 years
Number of patients with positive Antidrug Antibodies (ADAs)
The immunogenicity (ADAs) of novel study intervention in participants with CRC in the absence of liver metastases is investigated.
Time frame: Approximately 3 years