the Image

Clinical Trial Details

If you are a patient or a caregiver and would like to learn more our cancer clinical trials call toll-free 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials) or email cancerclinicaltrials@bsd.uchicago.edu .

Share this:
Brief Title Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Official Title A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5- Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Principal Investigator Sharma, Manish
Brief Summary This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.
Gender All
Ages 18 Years
Enrollment 645
Accepts Healthy Volunteers No
Lead Sponsor Array BioPharmaIndustry
Collaborator Merck KGaAIndustry
Study Design
Study Phase Phase 3
Study Type Interventional
Contact Name Haresh Jhangiani, MD
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition BRAF V600E-mutant Metastatic Colorectal Cancer
Detail for Health Professional (on clinicaltrials.gov)
More clinical trials by this PI