C4221022 - A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI-H/DMMR METASTATIC COLORECTAL CANCER

Conditions

MSI-H/dMMR metastatic colorectal cancer

Brief summary

PFS per investigator, defined as the time from randomization until PD based on investigator assessment per RECIST v1.1 or death due to any cause, whichever occurs first

Detailed description

Incidence and severity of AEs graded according to the NCI CTCAE v4.03 and changes in clinical laboratory test parameters, vital signs and ECGs, - Incidence of dosing interruptions, dose modifications and permanent discontinuations associated with AEs, - OS, defined as the time from the date of randomization to the date of death due to any cause, - Objective response, defined as confirmed CR or confirmed PR based on investigator assessment per RECIST v1.1, from the date of randomization until the date of the first documentation of PD, death or start of new anticancer therapy, - DOR, defined as the time from the first response, until PD based on investigator assessment per RECIST v1.1 or death due to any cause, whichever occurs first, BRAF and MSI-status as determined by retrospective central testing of baseline tumor tissue;, EORTC QLQ-C30: change from baseline in the global health status/QoL, functional and symptom scales, and single items, - EQ-5D-5L: change from baseline in the index score and VAS, - PGIS score: change from baseline in the score, - PGIC score

Related papers

No related papers found yet.

Interventions

DRUGENCORAFENIB

DRUGPEMBROLIZUMAB

DRUGCETUXIMAB

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS per investigator, defined as the time from randomization until PD based on investigator assessment per RECIST v1.1 or death due to any cause, whichever occurs first	—

Secondary

Measure	Time frame
Incidence and severity of AEs graded according to the NCI CTCAE v4.03 and changes in clinical laboratory test parameters, vital signs and ECGs, - Incidence of dosing interruptions, dose modifications and permanent discontinuations associated with AEs, - OS, defined as the time from the date of randomization to the date of death due to any cause, - Objective response, defined as confirmed CR or confirmed PR based on investigator assessment per RECIST v1.1, from the date of randomization until the date of the first documentation of PD, death or start of new anticancer therapy, - DOR, defined as the time from the first response, until PD based on investigator assessment per RECIST v1.1 or death due to any cause, whichever occurs first, BRAF and MSI-status as determined by retrospective central testing of baseline tumor tissue;, EORTC QLQ-C30: change from baseline in the global health status/QoL, functional and symptom scales, and single items, - EQ-5D-5L: change from baseline in the index	—

Measure

Time frame

Incidence and severity of AEs graded according to the NCI CTCAE v4.03 and changes in clinical laboratory test parameters, vital signs and ECGs, - Incidence of dosing interruptions, dose modifications and permanent discontinuations associated with AEs, - OS, defined as the time from the date of randomization to the date of death due to any cause, - Objective response, defined as confirmed CR or confirmed PR based on investigator assessment per RECIST v1.1, from the date of randomization until the date of the first documentation of PD, death or start of new anticancer therapy, - DOR, defined as the time from the first response, until PD based on investigator assessment per RECIST v1.1 or death due to any cause, whichever occurs first, BRAF and MSI-status as determined by retrospective central testing of baseline tumor tissue;, EORTC QLQ-C30: change from baseline in the global health status/QoL, functional and symptom scales, and single items, - EQ-5D-5L: change from baseline in the index

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Countries

Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden

Outcome results

None listed