A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)

Phase 2 Completed 1044 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years.

Timeline

Start: 2015-04-17
Primary completion: 2019-05-31
Completion: 2021-03-24

Publications

Ducreux M, Tabernero J, Grothey A, Arnold D, O'Dwyer PJ, Gilberg F, Abbas A, Thakur MD, Prizant H, Irahara N, Tahiri A, Schmoll HJ, Van Cutsem E, de Gramont A. Clinical and exploratory biomarker findings from the MODUL trial (Cohorts 1, 3 and 4) of biomarker-driven maintenance therapy for metastatic colorectal cancer. Eur J Cancer. 2023 May;184:137-150. doi: 10.1016/j.ejca.2023.01.023. Epub 2023 Feb 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	800 mg	Intravenous
Subject	Atezolizumab	Monoclonal antibody	840 mg	Intravenous
Subject	Bevacizumab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Cetuximab	Monoclonal antibody	500 mg/m2	Intravenous
Subject	Cobimetinib	Small molecule	60 mg	Oral
Subject	Leucovorin	Small molecule	400 mg/m2	Intravenous
Subject	Pertuzumab	Monoclonal antibody	420 mg	Intravenous
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Vemurafenib	Small molecule	960 mg	Oral
Subject	fluorouracil	Small molecule	1600 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	2400 mg/m2	Intravenous

A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)

Summary

Timeline

Publications

Drugs

Indications