Metastatic Colorectal Cancer
Conditions
Brief summary
Substudy 1 and 2: Objective response as assessed by the investigator: confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST, version 1.1. A repeat assessment must confirm response at least 28 days from the first documented response.
Detailed description
Substudy 1 and 2: Progression-Free Survival as assessed by the investigator: PFS is defined as the time from the first dose of study treatment to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier., Substudy 1 and 2: DOR as assessed by the investigator: The time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first. DOR is defined for subjects with confirmed CR/PR., Substudy 1 and 2: Overall survival: defined as the time from first dose of study treatment to the event of death from any cause., Substudy 1 and 2: Disease Control as assessed by the investigator: best overall response of confirmed CR or confirmed PR, or Stable Disease (SD) based on RECIST, version 1.1 as determined by the investigator.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Substudy 1 and 2: Objective response as assessed by the investigator: confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST, version 1.1. A repeat assessment must confirm response at least 28 days from the first documented response. | — |
Secondary
| Measure | Time frame |
|---|---|
| Substudy 1 and 2: Progression-Free Survival as assessed by the investigator: PFS is defined as the time from the first dose of study treatment to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier., Substudy 1 and 2: DOR as assessed by the investigator: The time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first. DOR is defined for subjects with confirmed CR/PR., Substudy 1 and 2: Overall survival: defined as the time from first dose of study treatment to the event of death from any cause., Substudy 1 and 2: Disease Control as assessed by the investigator: best overall response of confirmed CR or confirmed PR, or Stable Disease (SD) based on RECIST, version 1.1 as determined by the investigator. | — |
Countries
Austria, Czechia, France, Greece, Italy, Spain