TriangleNCT02928224 · CITED IN SOURCE DOCUMENTS
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
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2023-12-21
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
(Safety Lead-in) Number of Participants With Dose-Limiting Toxicities (DLTs)
(Safety Lead-in) Number of Participants With Adverse Events (AEs)
(Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Interim Analysis
(Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis
(Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis
(Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Final Analysis
(Phase 3) Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 of Triplet Arm vs. Control Arm
(Safety Lead-in) Objective Response Rate (ORR) by Investigator
(Safety Lead-in) Objective Response Rate (ORR) by BICR
(Safety Lead-in) Duration of Response (DOR) by Investigator
(Safety Lead-in) Duration of Response (DOR) by BICR
(Safety Lead-in) Time to Response by Investigator
(Safety Lead-in) Time to Response by BICR
(Safety Lead-in) Progression-Free Survival (PFS) by Investigator
(Safety Lead-in) Progression-Free Survival (PFS) by BICR
(Phase 3) Overall Survival (OS) in Doublet Arm vs. Control Arm
(Phase 3) Overall Survival (OS) in Triplet Arm vs. Doublet Arm
(Phase 3) Comparison of Progression-Free Survival (PFS) in Triplet Arm vs Control Arm Per BICR
(Phase 3) Comparison of Progression-free Survival (PFS) in Triplet Arm vs Control Arm Per Investigator
(Phase 3) Comparison of Progression-Free Survival (PFS) in Doublet Arm vs Control Arm Per BICR
(Phase 3) Comparison of Progression-Free Survival (PFS) in Doublet Arm vs Control Arm Per Investigator
(Phase 3) Comparison of Progression-Free Survival (PFS) in Triplet Arm vs Doublet Arm Per BICR
(Phase 3) Comparison of Progression-Free Survival (PFS) in Triplet Arm vs Doublet Arm Per Investigator
(Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Control Arm Per Investigator
(Phase 3) Comparison of Objective Response Rate (ORR) in Doublet Arm vs Control Arm Per BICR
(Phase 3) Comparison of Objective Response Rate (ORR) in Doublet Arm vs Control Arm Per Investigator
(Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Doublet Arm Per BICR
(Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Doublet Arm Per Investigator
(Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Control Arm Per BICR
(Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Control Arm Per Investigator
(Phase 3) Comparison of Duration of Response (DOR) in Doublet Arm vs Control Arm Per BICR
(Phase 3) Comparison of Duration of Response (DOR) in Doublet Arm vs Control Arm Per Investigator
(Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Doublet Arm by BICR
(Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Doublet Arm by Investigator
(Phase 3) Comparison of Time to Response in Triplet Arm vs Control Arm Per BICR
(Phase 3) Comparison of Time to Response in Triplet Arm vs Control Arm Per Investigator
(Phase 3) Comparison of Time to Response in Doublet Arm vs Control Arm Per BICR
(Phase 3) Comparison of Time to Response in Doublet Arm vs Control Arm Per Investigator
(Phase 3) Comparison of Time to Response in Triplet Arm vs Doublet Arm Per BICR
(Phase 3) Comparison of Time to Response in Triplet Arm vs Doublet Arm Per Investigator
(Phase 3) Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Participants (QLQ-C30) Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
(Phase 3) Change From Baseline in the Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
(Phase 3) Change From Baseline in the EuroQol-5D-5L Visual Analog Scale (EQ-5D-5L VAS) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
(Phase 3) Change From Baseline in the Participant Global Impression of Change (PGIC) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
(Safety Lead-in) Evaluation of the Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) for Cetuximab
(Safety Lead-in) Evaluation of the Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) for Encorafenib
(Safety Lead-in) Evaluation of the Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) for Binimetinib
(Safety Lead-in) Evaluation of the Area Under the Concentration-time Curve From Zero to the Last Measurable Time Point (AUClast) for Metabolite of Binimetinib (AR00426032)
(Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Cetuximab
(Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Encorafenib
(Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Binimetinib
(Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Metabolite of Binimetinib (AR00426032)
(Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Cetuximab
(Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Encorafenib
(Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Binimetinib
(Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Metabolite of Binimetinib (AR00426032)
(Safety Lead-in) Evaluation of the Steady-State Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for Binimetinib
(Safety Lead-in) Evaluation of the Steady-State Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for Encorafenib
(Safety Lead-in) Evaluation of the Steady-State Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for Cetuximab
(Safety Lead-in) Evaluation of the Steady-State Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for a Metabolite of Binimetinib
(Phase 3) Evaluation of the Model-Based Oral Clearance (CL/F) for Encorafenib
(Phase 3) Evaluation of the Model-Based Oral Clearance (CL/F) for Binimetinib
(Phase 3) Evaluation of the Model-Based Clearance (CL) for Cetuximab
Phase 3: Number of Participants With Clinically Notable Shifts in Hematology and Coagulation Laboratory Parameters
Phase 3: Number of Participants With Clinically Notable Shifts in Serum Chemistry Laboratory Parameters
Phase 3: Number of Participants With Clinically Notable Shifts in Urinalysis Laboratory Parameters
Phase 3: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities
Phase 3: Number of Participants With Newly Occurring Clinically Notable Electrocardiogram (ECG) Values
Phase 3: Number of Participants With Shift in Visual Acuity Logarithm of the Minimum Angle of Resolution (LogMAR) Score
Phase 3: Number of Participants With Shifts in Left Ventricular Ejection Fraction (LVEF) From Baseline to Maximum Grade On-treatment
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Key Inclusion Criteria: * Age ≥ 18 years at time of informed consent * Histologically- or cytologically-confirmed CRC that is metastatic * Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory * Progression of disease after 1 or 2 prior regimens in the metastatic setting * Evidence of measurable or evaluable non-measurable disease per RECIST, v1.1 * Adequate bone marrow, cardiac, kidney and liver function * Able to take oral medications * Female patients are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy from screening through follow-up if of childbearing potential * Males must agree to take appropriate precautions to avoid fathering a child from screening through follow-up Key Exclusion Criteria: * Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab, panitumumab or other epidermal growth factor receptor (EGFR) inhibitors * Prior irinotecan hypersensitivity or toxicity that would suggest an inability to tolerate irinotecan 180 mg/m2 every 2 weeks * Symptomatic brain metastasis or leptomeningeal disease * History or current evidence of retinal vein occlusion or current risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes) * Known history of acute or chronic pancreatitis * History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization * Uncontrolled blood pressure despite medical treatment * Impaired GI function or disease that may significantly alter the absorption of encorafenib or binimetinib (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption) * Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy * History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli * Concurrent neuromuscular disorder that is associated with the potential of elevated creatine (phosphor)kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) * Residual common terminology criteria for adverse events (CTCAE) ≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 neuropathy * Known history of HIV infection * Active hepatitis B or hepatitis C infection * Known history of Gilbert's syndrome * Known contraindication to receive cetuximab or irinotecan at the planned doses
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Encorafenib + binimetinib + cetuximab.
- intervention Names
- Drug: Encorafenib
- Drug: Binimetinib
- Drug: Cetuximab
- label
- Safety Lead-in, Triplet Arm
- type
- EXPERIMENTAL
- description
- Encorafenib + cetuximab.
- intervention Names
- Drug: Encorafenib
- Drug: Cetuximab
- label
- Doublet Arm
- type
- EXPERIMENTAL
- description
- Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.
- intervention Names
- Drug: Cetuximab
- Drug: Irinotecan
- Drug: Folinic Acid
- Drug: 5-Fluorouracil
- label
- Control Arm
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Doublet Arm
- Safety Lead-in, Triplet Arm
- description
- Orally, once daily.
- name
- Encorafenib
- type
- DRUG
- arm Group Labels
- Safety Lead-in, Triplet Arm
- description
- Orally, twice daily.
- name
- Binimetinib
- type
- DRUG
- arm Group Labels
- Control Arm
- Doublet Arm
- Safety Lead-in, Triplet Arm
- description
- Standard of care.
- name
- Cetuximab
- type
- DRUG
- arm Group Labels
- Control Arm
- description
- Standard of care.
- name
- Irinotecan
- type
- DRUG
- arm Group Labels
- Control Arm
- description
- Standard of care.
- name
- Folinic Acid
- other Names
- FA
- type
- DRUG
- arm Group Labels
- Control Arm
- description
- Standard of care.
- name
- 5-Fluorouracil
- other Names
- 5-FU
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- SEQUENTIAL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 702
- type
- ACTUAL
Registered outcome plans (not posted results)
- other Outcomes
- description
- OS was defined as the time from randomization to death due to any cause.
- measure
- (Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Final Analysis
- time Frame
- From randomization to death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
- primary Outcomes
- measure
- (Safety Lead-in) Number of Participants With Dose-Limiting Toxicities (DLTs)
- time Frame
- Cycle 1 (up to 28 days)
- description
- An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants reporting AEs were reported in this outcome measure.
- measure
- (Safety Lead-in) Number of Participants With Adverse Events (AEs)
- time Frame
- Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
- description
- An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants with dose interruptions, dose modifications and dose discontinuations due to AEs were reported in this outcome measure.
- measure
- (Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Interim Analysis
- time Frame
- Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
- description
- An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants according to incidence of dose interruptions, dose modifications and dose discontinuations due to AEs were reported in this outcome measure.
- measure
- (Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis
- time Frame
- From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)
- description
- OS was defined as the time from randomization to death due to any cause.
- measure
- (Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis
- time Frame
- From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.1 weeks for triplet arm and 52.4 weeks for control arm)
- description
- ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of complete response (CR) or partial response (PR), where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits.
- measure
- (Phase 3) Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 of Triplet Arm vs. Control Arm
- time Frame
- Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
- secondary Outcomes
- description
- ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits.
- measure
- (Safety Lead-in) Objective Response Rate (ORR) by Investigator
- time Frame
- From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)
- description
- ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits.
- measure
- (Safety Lead-in) Objective Response Rate (ORR) by BICR
- time Frame
- From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)
- description
- DOR was defined as the time from first radiographic evidence of response to the earliest documented disease progression (PD) or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
- measure
- (Safety Lead-in) Duration of Response (DOR) by Investigator
- time Frame
- From time of response to the earliest documented PD or death due to underlying disease (maximum treatment exposure of 280 weeks)
- description
- DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
- measure
- (Safety Lead-in) Duration of Response (DOR) by BICR
- time Frame
- From time of response to the earliest documented PD or death due to underlying disease (maximum treatment exposure of 280 weeks)
- description
- Time to response was defined as the time from first dose to first radiographic evidence of response.
- measure
- (Safety Lead-in) Time to Response by Investigator
- time Frame
- From first dose to first radiographic evidence of response (maximum treatment exposure of 280 weeks)
- description
- Time to response was defined as the time from first dose to first radiographic evidence of response.
- measure
- (Safety Lead-in) Time to Response by BICR
- time Frame
- From first dose to first radiographic evidence of response (maximum treatment exposure of 280 weeks)
- description
- PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
- measure
- (Safety Lead-in) Progression-Free Survival (PFS) by Investigator
- time Frame
- From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 280 weeks)
- description
- PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
- measure
- (Safety Lead-in) Progression-Free Survival (PFS) by BICR
- time Frame
- From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 280 weeks)
- description
- OS was defined as the time from randomization to death due to any cause.
- measure
- (Phase 3) Overall Survival (OS) in Doublet Arm vs. Control Arm
- time Frame
- From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.7 weeks for doublet arm and 52.4 weeks for control arm)
- description
- OS was defined as the time from randomization to death due to any cause.
- measure
- (Phase 3) Overall Survival (OS) in Triplet Arm vs. Doublet Arm
- time Frame
- From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.7 weeks for doublet arm and 89.1 weeks for triplet arm)
- description
- PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
- measure
- (Phase 3) Comparison of Progression-Free Survival (PFS) in Triplet Arm vs Control Arm Per BICR
- time Frame
- From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
- description
- PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
- measure
- (Phase 3) Comparison of Progression-free Survival (PFS) in Triplet Arm vs Control Arm Per Investigator
- time Frame
- From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
Full study description
- 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.
Source references
- references
- citation
- Kopetz S, Murphy DA, Pu J, Ciardiello F, Desai J, Van Cutsem E, Wasan HS, Yoshino T, Saffari H, Zhang X, Hamilton P, Xie T, Yaeger R, Tabernero J. Molecular profiling of BRAF-V600E-mutant metastatic colorectal cancer in the phase 3 BEACON CRC trial. Nat Med. 2024 Nov;30(11):3261-3271. doi: 10.1038/s41591-024-03235-9. Epub 2024 Sep 23.
- pmid
- 39313594
- type
- DERIVED
- citation
- Taieb J, Lonardi S, Desai J, Folprecht G, Gallois C, Marques EP, Khan S, Castagne C, Wasan H. Adverse Events Associated with Encorafenib Plus Cetuximab in Patients with BRAFV600E-mutant Metastatic Colorectal Cancer: An in-depth Analysis of the BEACON CRC Study. Clin Colorectal Cancer. 2023 Mar;22(1):59-66. doi: 10.1016/j.clcc.2022.12.003. Epub 2022 Dec 24.
- pmid
- 36653241
- type
- DERIVED
- citation
- Stintzing S, Seufferlein T, Rose C, Reichenbach F, Luftner D. Encorafenib in Combination With Cetuximab After Systemic Therapy in Patients With BRAFV600E Mutant Metastatic Colorectal Cancer: German Health Technology Assessment-Driven Analyses From the BEACON CRC Study. Clin Colorectal Cancer. 2022 Sep;21(3):244-251. doi: 10.1016/j.clcc.2022.04.002. Epub 2022 May 5.
- pmid
- 35654691
- type
- DERIVED
- citation
- Kopetz S, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Belani A, Zhang X, Tabernero J. Quality of life with encorafenib plus cetuximab with or without binimetinib treatment in patients with BRAF V600E-mutant metastatic colorectal cancer: patient-reported outcomes from BEACON CRC. ESMO Open. 2022 Jun;7(3):100477. doi: 10.1016/j.esmoop.2022.100477. Epub 2022 May 30.
- pmid
- 35653981
- type
- DERIVED
- citation
- Tabernero J, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Elez E, Gollerkeri A, Maharry K, Christy-Bittel J, Kopetz S. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021 Feb 1;39(4):273-284. doi: 10.1200/JCO.20.02088.
- pmid
- 33503393
- type
- DERIVED
- citation
- Kopetz S, Grothey A, Yaeger R, Van Cutsem E, Desai J, Yoshino T, Wasan H, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Pfeiffer P, Orlov S, Lonardi S, Elez E, Kim TW, Schellens JHM, Guo C, Krishnan A, Dekervel J, Morris V, Calvo Ferrandiz A, Tarpgaard LS, Braun M, Gollerkeri A, Keir C, Maharry K, Pickard M, Christy-Bittel J, Anderson L, Sandor V, Tabernero J. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer. N Engl J Med. 2019 Oct 24;381(17):1632-1643. doi: 10.1056/NEJMoa1908075. Epub 2019 Sep 30.
- pmid
- 31566309
- type
- DERIVED
- citation
- Van Cutsem E, Huijberts S, Grothey A, Yaeger R, Cuyle PJ, Elez E, Fakih M, Montagut C, Peeters M, Yoshino T, Wasan H, Desai J, Ciardiello F, Gollerkeri A, Christy-Bittel J, Maharry K, Sandor V, Schellens JHM, Kopetz S, Tabernero J. Binimetinib, Encorafenib, and Cetuximab Triplet Therapy for Patients With BRAF V600E-Mutant Metastatic Colorectal Cancer: Safety Lead-In Results From the Phase III BEACON Colorectal Cancer Study. J Clin Oncol. 2019 Jun 10;37(17):1460-1469. doi: 10.1200/JCO.18.02459. Epub 2019 Mar 20.
- pmid
- 30892987
- type
- DERIVED
- see Also Links
- label
- To obtain contact information for a study center near you, click here.
Source notices and limitations
Discovery and provenance
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- (BRAF inhibitor), binimetinib (MEK inhibitor), and cetuximab (EGFR inhibitor): In the international, open-label, randomized, phase III <a href="/clinicaltrials/NCT02928224">BEACON</a> trial, patients with metastatic colorectal cancer and <em class="gene-name">BRAF</em> V600E variants who previously received one or two treatment r
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Preserved source evidence · Independent clinical review pending · Not medical advice