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)

Conditions

Colorectal cancer

Brief summary

Master/Sub 1: • Incidence and severity of AEs/SAEs • Change from baseline in vital signs, clinical laboratory assessments, ECGs, ECOG performance status, and physical examination, Sub 1: PFS is defined as the time from randomization until progression per RECIST 1.1, or death due to any cause. The measure of interest is the difference in the PFS

Detailed description

Sub 1: OS is defined as the time from randomization until the date of death due to any cause. The measure of interest is the HR of OS, Sub 1: ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined per RECIST 1.1. The measure of interest is the difference in ORR, Sub-1: DCR is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1. The measure of interest is the difference in DCR, 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. The measure of interest is the difference in the median DoR, Sub 1: PFS2 is defined as the time from randomization to the earliest of the progression event, after first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice. The measure of interest is the HR of PFS2, Sub 1: Concentration of volrustomig in serum and PK parameters as data allow (such as peak and trough concentrations), Sub 1: Presence of ADAs against volrustomig in serum (confirmatory results: positive or negative, titers)

Related papers

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Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGCALCIUM FOLINATE

DRUGIRINOTECAN HYDROCHLORIDE TRIHYDRATE

DRUGINFLIXIMAB

DRUGFOLINIC ACID

DRUGBEVACIZUMAB

DRUGvolrustomig

DRUGFLUOROURACIL

DRUGMYCOPHENOLATE MOFETIL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Master/Sub 1: • Incidence and severity of AEs/SAEs • Change from baseline in vital signs, clinical laboratory assessments, ECGs, ECOG performance status, and physical examination, Sub 1: PFS is defined as the time from randomization until progression per RECIST 1.1, or death due to any cause. The measure of interest is the difference in the PFS	—

Secondary

Measure	Time frame
Sub 1: OS is defined as the time from randomization until the date of death due to any cause. The measure of interest is the HR of OS, Sub 1: ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined per RECIST 1.1. The measure of interest is the difference in ORR, Sub-1: DCR is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1. The measure of interest is the difference in DCR, 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. The measure of interest is the difference in the median DoR, Sub 1: PFS2 is defined as the time from randomization to the earliest of the progression event, after first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice. The m	—

Measure

Time frame

Sub 1: OS is defined as the time from randomization until the date of death due to any cause. The measure of interest is the HR of OS, Sub 1: ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined per RECIST 1.1. The measure of interest is the difference in ORR, Sub-1: DCR is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1. The measure of interest is the difference in DCR, 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. The measure of interest is the difference in the median DoR, Sub 1: PFS2 is defined as the time from randomization to the earliest of the progression event, after first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice. The m

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Countries

France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

​​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)