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Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer
Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer

NCT03693170

CompletedPhase 2

Sponsor: Pierre Fabre Medicament

Conditions: BRAF V600E-mutant Metastatic Colorectal Cancer

Interventions: encorafenib, Binimetinib, Cetuximab

Countries: United States, Austria, Belgium, France, Italy, Japan, Netherlands, Spain

The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Histologically or cytologically confirmed CRC that is metastatic
* Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening
* Evidence of measurable disease as per RECIST, v1.1
* Subject able to receive cetuximab as per approved label with regards to RAS status
* Eastern Cooperative Oncology Group Status (ECOG) 0 or 1
* Adequate renal, hepatic, cardiac and bone marrow functions and adequate electrolytes as per protocol
* Subject able to take oral medications

Exclusion Criteria:

* Prior systemic therapy for metastatic disease
* Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab or other anti-EGFR inhibitors
* Symptomatic brain metastasis or Leptomeningeal disease
* History or current evidence of Retinal Vein Occlusion (RVO) or current risk factors for RVO
* History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to first dose.
* Impaired cardiovascular function or clinically significant cardiovascular diseases: history of myocardial infarction or coronary disorders within 6 months prior to start of study treatment, symptomatic congestive heart failure (grade 2 or higher), past or current clinically significant arrhythmia and/or conduction disorder within 6 months prior to study treatment start
* History of thromboembolic or cerebrovascular events within 6 months prior to start of study treatment
* Concurrent neuromuscular disorder that is associated with potential elevation of Creatine Kinase
* Known contraindication to cetuximab administration as per SPC/approved label
Locations (45)
  • New York, New York, United States
  • Germantown, Tennessee, United States
  • Vienna, Austria
  • Ghent, East Flanders, Belgium
  • Leuven, Flemish Brabant, Belgium
  • Brussels, Belgium
  • Montpellier, Cedex 5, France
  • Brest, France
  • Marseille, France
  • Paris, France
  • Paris, France
  • Paris, France
  • Pessac, France
  • Saint-Herblain, France
  • Toulouse, France
  • San Giovanni Rotondo, Foggia, Italy
  • Meldola, Forlì-Cesena, Italy
  • Candiolo, Italy
  • Genova, Italy
  • Perugia, Italy
  • Nagoya, Aichi-ken, Japan
  • Kashiwa, Chiba, Japan
  • Fukuoka, Fukuoka, Japan
  • Osaka, Osaka, Japan
  • Nagaizumi-cho, Shizuoka, Japan
  • Koto-ku,, Tokyo, Japan
  • Utrecht, Netherlands
  • Madrid, Madrid, Spain
  • Pamplona, Navarre, Spain
  • Barcelona, Spain
  • + 15 more on CT.gov