Clinical trial NCT02928224: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: BRAF V600E-mutant Metastatic Colorectal Cancer
Keywords: Colorectal cancer
BRAF
BRAFV600E
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
name: Pierre Fabre Medicament
name: Ono Pharmaceutical Co. Ltd
First posted: 2016-10-10
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: (Safety Lead-in) Number of Participants With Dose-Limiting Toxicities (DLTs)
timeFrame: Cycle 1 (up to 28 days)
measure: (Safety Lead-in) Number of Participants With Adverse Events (AEs)
timeFrame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
measure: (Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Interim Analysis
timeFrame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
measure: (Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis
timeFrame: From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)
measure: (Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis
timeFrame: 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)
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
timeFrame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
Secondary outcomes:
measure: (Safety Lead-in) Objective Response Rate (ORR) by Investigator
timeFrame: From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)
measure: (Safety Lead-in) Objective Response Rate (ORR) by BICR
timeFrame: From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)
measure: (Safety Lead-in) Duration of Response (DOR) by Investigator
timeFrame: From time of response to the earliest documented PD or death due to underlying disease (maximum treatment exposure of 280 weeks)
measure: (Safety Lead-in) Duration of Response (DOR) by BICR
timeFrame: From time of response to the earliest documented PD or death due to underlying disease (maximum treatment exposure of 280 weeks)
measure: (Safety Lead-in) Time to Response by Investigator
timeFrame: From first dose to first radiographic evidence of response (maximum treatment exposure of 280 weeks)
measure: (Safety Lead-in) Time to Response by BICR
timeFrame: From first dose to first radiographic evidence of response (maximum treatment exposure of 280 weeks)
measure: (Safety Lead-in) Progression-Free Survival (PFS) by Investigator
timeFrame: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 280 weeks)
measure: (Safety Lead-in) Progression-Free Survival (PFS) by BICR
timeFrame: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 280 weeks)
measure: (Phase 3) Overall Survival (OS) in Doublet Arm vs. Control Arm
timeFrame: 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)
measure: (Phase 3) Overall Survival (OS) in Triplet Arm vs. Doublet Arm
timeFrame: 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)
measure: (Phase 3) Comparison of Progression-Free Survival (PFS) in Triplet Arm vs Control Arm Per BICR
timeFrame: 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)
measure: (Phase 3) Comparison of Progression-free Survival (PFS) in Triplet Arm vs Control Arm Per Investigator
timeFrame: 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)
measure: (Phase 3) Comparison of Progression-Free Survival (PFS) in Doublet Arm vs Control Arm Per BICR
timeFrame: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)
measure: (Phase 3) Comparison of Progression-Free Survival (PFS) in Doublet Arm vs Control Arm Per Investigator
timeFrame: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)
measure: (Phase 3) Comparison of Progression-Free Survival (PFS) in Triplet Arm vs Doublet Arm Per BICR
timeFrame: 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 268 weeks for doublet arm)
measure: (Phase 3) Comparison of Progression-Free Survival (PFS) in Triplet Arm vs Doublet Arm Per Investigator
timeFrame: 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 268 weeks for doublet arm)
measure: (Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Control Arm Per Investigator
timeFrame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
measure: (Phase 3) Comparison of Objective Response Rate (ORR) in Doublet Arm vs Control Arm Per BICR
timeFrame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
measure: (Phase 3) Comparison of Objective Response Rate (ORR) in Doublet Arm vs Control Arm Per Investigator
timeFrame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
measure: (Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Doublet Arm Per BICR
timeFrame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
measure: (Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Doublet Arm Per Investigator
timeFrame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
measure: (Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Control Arm Per BICR
timeFrame: From time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
measure: (Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Control Arm Per Investigator
timeFrame: From time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
measure: (Phase 3) Comparison of Duration of Response (DOR) in Doublet Arm vs Control Arm Per BICR
timeFrame: From time of response to PD or death due to underlying disease (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)
measure: (Phase 3) Comparison of Duration of Response (DOR) in Doublet Arm vs Control Arm Per Investigator
timeFrame: From time of response to PD or death due to underlying disease (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)
measure: (Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Doublet Arm by BICR
timeFrame: From time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)
measure: (Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Doublet Arm by Investigator
timeFrame: From time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)
measure: (Phase 3) Comparison of Time to Response in Triplet Arm vs Control Arm Per BICR
timeFrame: From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
measure: (Phase 3) Comparison of Time to Response in Triplet Arm vs Control Arm Per Investigator
timeFrame: From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
measure: (Phase 3) Comparison of Time to Response in Doublet Arm vs Control Arm Per BICR
timeFrame: From first dose to first radiographic evidence of response (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)
measure: (Phase 3) Comparison of Time to Response in Doublet Arm vs Control Arm Per Investigator
timeFrame: From first dose to first radiographic evidence of response (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)
measure: (Phase 3) Comparison of Time to Response in Triplet Arm vs Doublet Arm Per BICR
timeFrame: From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)
measure: (Phase 3) Comparison of Time to Response in Triplet Arm vs Doublet Arm Per Investigator
timeFrame: From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)
measure: (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
timeFrame: Baseline, Cycle(C)1 Day(D)1 , C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
measure: (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
timeFrame: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
measure: (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
timeFrame: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
measure: (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
timeFrame: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) for Cetuximab
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) for Encorafenib
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) for Binimetinib
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (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)
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Cetuximab
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Encorafenib
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Binimetinib
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Metabolite of Binimetinib (AR00426032)
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Cetuximab
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Encorafenib
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Binimetinib
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Metabolite of Binimetinib (AR00426032)
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Steady-State Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for Binimetinib
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Steady-State Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for Encorafenib
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Steady-State Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for Cetuximab
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Safety Lead-in) Evaluation of the Steady-State Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for a Metabolite of Binimetinib
timeFrame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)
measure: (Phase 3) Evaluation of the Model-Based Oral Clearance (CL/F) for Encorafenib
timeFrame: 2 and 6 hours post-dose on Day 1 of Cycle 1, Predose and 2 hours post-dose on Day 1 of Cycle 2 (each cycle of 28 days)
measure: (Phase 3) Evaluation of the Model-Based Oral Clearance (CL/F) for Binimetinib
timeFrame: 2 and 6 hours post-dose on Day 1 of Cycle 1, Predose and 2 hours post-dose on Day 1 of Cycle 2 (each cycle of 28 days)
measure: (Phase 3) Evaluation of the Model-Based Clearance (CL) for Cetuximab
timeFrame: 2 and 6 hours post-dose on Day 1 of Cycle 1, Predose and 2 hours post-dose on Day 1 of Cycle 2 (each cycle of 28 days)
measure: Phase 3: Number of Participants With Clinically Notable Shifts in Hematology and Coagulation Laboratory Parameters
timeFrame: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
measure: Phase 3: Number of Participants With Clinically Notable Shifts in Serum Chemistry Laboratory Parameters
timeFrame: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
measure: Phase 3: Number of Participants With Clinically Notable Shifts in Urinalysis Laboratory Parameters
timeFrame: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
measure: Phase 3: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities
timeFrame: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
measure: Phase 3: Number of Participants With Newly Occurring Clinically Notable Electrocardiogram (ECG) Values
timeFrame: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
measure: Phase 3: Number of Participants With Shift in Visual Acuity Logarithm of the Minimum Angle of Resolution (LogMAR) Score
timeFrame: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
measure: Phase 3: Number of Participants With Shifts in Left Ventricular Ejection Fraction (LVEF) From Baseline to Maximum Grade On-treatment
timeFrame: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)
Other outcomes:
measure: (Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Final Analysis
timeFrame: From randomization to death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Duarte
country: United States
facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
state: California
city: Fountain Valley
country: United States
facility: Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC - Norris Healthcare Center (HC3)
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: LAC+USC Medical Center
state: California
city: Los Angeles
country: United States
facility: Norris Healthcare Center 3 (HC3)
state: California
city: Los Angeles
country: United States
facility: USC Eye Institute
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Orange
country: United States
facility: Harvard Eye Associates
state: California
city: Aurora
country: United States
facility: Rocky Mountain Lions Eye Institute
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Cancer Center - Anschutz Cancer Pavilion
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver CTO (CTRC)
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital Inpatient Pavillion'
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale - New Haven
state: Connecticut
city: New Haven
country: United States
facility: Temple Medical Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University, Yale Cancer Center
state: Connecticut
city: North Haven
country: United States
facility: Smilow Cancer Hospital Care Center at North Haven
state: Connecticut
city: Coral Gables
country: United States
facility: The Lennar Foundation Medical Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Dr. Clayton Berger (opthalmology)
state: Florida
city: Fort Lauderdale
country: United States
facility: Mehmet F. Hepgur, MD - Broward Health Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center/UMHC
state: Florida
city: Miami
country: United States
facility: Sylvester at Kendall
state: Florida
city: Bloomington
country: United States
facility: Illinois CancerCare- Bloomington
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Galesburg
country: United States
facility: Illinois CancerCare- Galesburg
state: Illinois
city: New Lenox
country: United States
facility: University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
state: Illinois
city: Orland Park
country: United States
facility: The University of Chicago Medicine Center for Advanced Care Orland Park
state: Illinois
city: Ottawa
country: United States
facility: Illinois CancerCare- Ottawa
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care, PC
state: Illinois
city: Peoria
country: United States
facility: Illinois Eye Center
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Investigational Drug Services IUHSCC
state: Indiana
city: Indianapolis
country: United States
facility: Sidney &Lois Eskenazi Hospital
state: Indiana
city: Indianapolis
country: United States
facility: IU Health Springmill
state: Indiana
city: New Albany
country: United States
facility: Baptist Health Floyd Cancer Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Fairway
country: United States
facility: The University of Kansas Clinical Research Center
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Hospital
state: Kansas
city: Prairie Village
country: United States
facility: KU Eye
state: Kansas
city: Westwood
country: United States
facility: The University of Kansas Cancer Center and Medical Pavilion
state: Kansas
city: Westwood
country: United States
facility: The University of Kansas Cancer Center, Investigational Drug Services
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Baltimore
country: United States
facility: The Investigational Drug Pharmacy (IDS) in the Sidney Kimmel Cancer Center at Johns Hopkins
state: Maryland
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston Inc
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute (DFCI)
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Creve Coeur
country: United States
facility: Siteman Cancer Center - West County
state: Missouri
city: Saint Louis
country: United States
facility: SSM Health Saint Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: SSM Health Saint Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Infusion Center Pharmacy
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Siteman Cancer Center - South County
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center - St Peters
state: Missouri
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering: Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering: Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering: Rockefeller Outpatient Pavilion
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute
state: Ohio
city: Portland
country: United States
facility: Casey Eye Institute-South Waterfront
state: Oregon
city: Portland
country: United States
facility: OHSU Center for Health and Healing
state: Oregon
city: Portland
country: United States
facility: OHSU Research Pharmacy Services
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Nashville
country: United States
facility: Henry-Joyce Cancer Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Temple
country: United States
facility: Scott & White Clinic - Temple Pavilion
state: Texas
city: Temple
country: United States
facility: Scott & White Medical Center - Temple
state: Texas
city: Spokane Valley
country: United States
facility: Medical Oncology Associates, PS DBA Summit Cancer Centers
state: Washington
city: Spokane
country: United States
facility: Spokane Eye Clinic
state: Washington
city: Spokane
country: United States
facility: Inland Imaging, LLC Holy Family Hospital
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates, PS DBA Summit Cancer Centers
state: Washington
city: Spokane
country: United States
facility: Providence Holy Family Nuclear Medicine
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Clinical Science Center
state: Wisconsin
city: Pergamino
country: Argentina
facility: CLINICA PERGAMINO S.A. (Centro de Investigacion Pergamino S.A.)
state: Buenos Aires
city: Santa Rosa
country: Argentina
facility: Centro Medico INFINITO
state: LA Pampa
city: San Miguel de Tucumán
country: Argentina
facility: Centro Medico CAIPO (Centro para la Atención del paciente Oncológico)
state: Tucumán
city: Cordoba
country: Argentina
facility: Clinica Universitaria Reina Fabiola
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral - CORI
city: Darlinghurst
country: Australia
facility: St Vincent's Clinic
state: NEW South Wales (nsw)
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: NEW South Wales (nsw)
city: Parramatta
country: Australia
facility: Marsden Eye Specialists
state: NEW South Wales (nsw)
city: Sydney
country: Australia
facility: Newcastle Eye Centre
state: NEW South Wales (nsw)
city: South Brisbane
country: Australia
facility: Mater Misericordiae Limited
state: Queensland
city: Adelaide
country: Australia
facility: Central Adelaide Local Health Network Inc. operating as Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Woodville South
country: Australia
facility: Central Adelaide Local Health Network Inc. operating as The Queen Elizabeth Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Health Translation Precinct - Monash Health
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Wels
country: Austria
facility: Klinikum Wels - Grieskirchen GmbH, Abteilung fuer Innere Medizin IV
state: Oberoesterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH, Abteilung fuer Augenheilkunde und Optometrie
state: Oberoesterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH, Abteilung fuer Innere Medizin II
state: Oberoesterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH, Institut fuer Nuklearmedizin
state: Oberoesterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH, Institut fuer Radiologie I
state: Oberoesterreich
city: Wien
country: Austria
facility: DZU, Diagnose Zentrum Urania GmbH
city: Wien
country: Austria
facility: AKH Wien
city: Wien
country: Austria
facility: Medizinische Universitaet Wien/AKH Wien
city: Wien
country: Austria
facility: Medizinische Universität Wien/AKH Wien
city: Libramont-Chevigny
country: Belgium
facility: Centre Hospitalier de l'Ardenne - Site de Libramont
state: Luxembourg
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
state: WEST Vlaanderen
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi (GHdC)
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg (UZ Leuven)
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire (CHU) de Liege
city: Liege
country: Belgium
facility: CHC Saint Joseph
city: Roeselaere
country: Belgium
facility: AZ Delta Roeselaere-Menen
city: Verviers
country: Belgium
facility: Centre Hospitalier Regional (CHR) - Verviers
city: Salvador
country: Brazil
facility: Hospital do Olho
state: Bahia
city: Salvador
country: Brazil
facility: CENOB - Centro de Oncologia da Bahia SS Ltda / Oncovida
state: Bahia
city: Cachoeiro de Itapemirim
country: Brazil
facility: CEMES Centro Medico Especializado em Oftalmologia
state: ES
city: Cachoeiro de Itapemirim
country: Brazil
facility: Centro de Pesquisas Clínicas em Oncologia
state: ES
city: Cachoeiro de Itapemirim
country: Brazil
facility: Hospital Evangelico de Cachoeiro de Itapemirim
state: ES
city: Belo Horizonte
country: Brazil
facility: Instituto Vizibelli
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: CENANTRON - Centro Avancado de Tratamento Oncologic
state: Minas Gerais
city: Caxias do Sul
country: Brazil
facility: Fundação Universidade de Caxias do Sul
state: RS
city: Lajeado
country: Brazil
facility: Daniel Lubisco Pandolfi
state: RS
city: Lajeado
country: Brazil
facility: Sociedade Beneficencia e Cardade de Lajeado/Hospital Bruno Born
state: RS
city: Lajeado
country: Brazil
facility: Sociedade Beneficencia e Cardade de Lajeado/Hospital Bruno Born
state: RS
city: Passo Fundo
country: Brazil
facility: Associacao Hospitalar Beneficente Sao Vicente de Paulo / Hospital Sao Vicente de Paulo
state: RS
city: Passo Fundo
country: Brazil
facility: Consultorio Medico de Oftalmologia - Dr. Ricardo Tres
state: RS
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo
state: RS
city: Pelotas
country: Brazil
facility: Thiago Vernetti Ferreira
state: RS
city: Pelotas
country: Brazil
facility: Leandro Becker
state: RS
city: Pelotas
country: Brazil
facility: Fernanda Mendes
state: RS
city: Pelotas
country: Brazil
facility: UPCO - Unidade de Pesquisas Clinicas em Oncologia
state: RS
city: Pelotas
country: Brazil
facility: Fernanda Lauermann
state: RS
city: Porto Alegre
country: Brazil
facility: Diogo Duarte Torre
state: RS
city: Porto Alegre
country: Brazil
facility: Farmacia Central da Irmandade da Santa Casa de Misericordia de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Nucleo de Novos Tratamentos em Cancer
state: RS
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa Clínica de Oncologia e Hematologia - Hospital Mãe de Deus/AESC
state: RS
city: Porto Alegre
country: Brazil
facility: Clinica de Oftalmologia Lavinsky
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus
state: RS
city: Barretos
country: Brazil
facility: Clinica Toller
state: SAO Paulo
city: Barretos
country: Brazil
facility: Olhos Centro Diagnostico e Laser LTDA
state: SAO Paulo
city: Barretos
country: Brazil
facility: Fundacao Pio XII
state: SAO Paulo
city: Itajai
country: Brazil
facility: Giuliano Santos Borges - ME / Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai
state: SC
city: Santo Andre
country: Brazil
facility: FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC
state: SP
city: Santo Andre
country: Brazil
facility: FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC
state: SP
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
state: SP
city: Sorocaba
country: Brazil
facility: CEPOS - Centro de Estudos e Pesquisas Oncologicas de Sorocaba
state: SP
city: Sorocaba
country: Brazil
facility: Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"
state: SP
city: Sorocaba
country: Brazil
facility: Karen Miyuki Kubokawa Shorer
state: SP
city: Sorocaba
country: Brazil
facility: Oftalmologia Diagnostica de Sorocaba (ODS)
state: SP
city: São Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa São Lucas
city: São Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa São Lucas - Pharmacy
city: São Paulo
country: Brazil
facility: Hospital Leforte
city: São Paulo
country: Brazil
facility: IPEPO - Instituto da Visao
city: Vancouver
country: Canada
facility: Eye Care Centre, Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer, Vancouver Center
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre integre universitaire de sante et de services sociaux de l'Ouest-de-l'Ile-de-Montreal
state: Quebec
city: Temuco
country: Chile
facility: Instituto Clinico Oncologico del Sur (ICOS)
state: Region DE LA Araucania
city: Vina del Mar
country: Chile
facility: Hospital Clinico Vina Del Mar
state: V Region Valparaiso
city: Brno
country: Czechia
facility: Ocni ordinace Oftalpro s.r.o.
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Hradec Kralove
country: Czechia
facility: Fingerlanduv ustav patologie
city: Hradec Kralove
country: Czechia
facility: I. interni kardioangiologicka klinika
city: Hradec Kralove
country: Czechia
facility: Klinika nemoci koznich a pohlavnich
city: Hradec Kralove
country: Czechia
facility: Nemocnicni lekarna - Usek klinickych studii
city: Hradec Kralove
country: Czechia
facility: Ocni klinika
city: Hradec Kralove
country: Czechia
facility: Radiologicka klinika
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc, I. interni klinika - kardiologicka
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc, Lekarna
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Odense C
country: Denmark
facility: Odense University Hospital (OUH)
city: Besancon Cedex
country: France
facility: Hopital Jean Minjoz
city: BREST Cedex
country: France
facility: CHU Morvan
city: Ecully
country: France
facility: Centre Ophtalmologique - Pole Vision - Clinique Val d'Ouest
city: Lyon Cedex 08
country: France
facility: Centre Leon Berard
city: Montpellier Cedex 5
country: France
facility: ICM Val d'Aurelle
city: Nantes Cedex
country: France
facility: CHU HOTEL-Dieu
city: Paris Cedex 12
country: France
facility: Centre hospitalier national d'ophtalmologie des Quinze-Vingts
city: Paris Cedex 12
country: France
facility: Centre Hospitalier National d'Opthalmologie des Quinze-Vingts (CHNO des XV-XX)
city: Paris
country: France
facility: Hopital Georges Pompidou
city: Reims Cedex
country: France
facility: CHU Robert Debre
city: Saint Jeand De Vedas
country: France
facility: SCM Centre d'ophtalmologie
city: Toulouse Cedex 9
country: France
facility: CHU Toulouse-Institut Inuversitaire du Cancer Toulouse
city: Toulouse Cedex 9
country: France
facility: CHU Toulouse-Rangueil
city: Toulouse
country: France
facility: CHU Toulouse - Purpan, hopital Pierre-Paul Riquet
city: Villejuif Cedex
country: France
facility: Gustave Roussy
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden-wuerttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
state: Baden-wuerttemberg
city: Muenchen
country: Germany
facility: Augenklinik der Universitaet Muenchen
state: Bayern
city: Muenchen
country: Germany
facility: LMU Klinikum der Universitaet Muenchen, Campus Grosshadern
state: Bayern
city: Falkensee
country: Germany
facility: Augenarzt-Gemeinschaftspraxis Dr.med.Andreas Kind & Dr.med. Ute Kariger-Schweigert
state: Brandenburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
state: Niedersachsen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Essen
country: Germany
facility: Kliniken Essen Mitte / Knappschaftskrankenhaus
state: Nordrhein-westfalen
city: Essen
country: Germany
facility: Praxis fuer Augenheilkunde Dr. Edmund Meyer-Schwickerath
state: Nordrhein-westfalen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
state: Nordrhein-westfalen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen (AoeR), Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum
state: Nordrhein-westfalen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen; Diagnostischeu. Interventionelle Radiologie u. Neuroradiologie
state: Nordrhein-westfalen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen; Nuklearmedizin
state: Nordrhein-westfalen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen; Zentralapotheke
state: Nordrhein-westfalen
city: Essen
country: Germany
facility: Evang. Krankenhaus Essen - Werden; Klinik fuer Augenheilkunde
state: Nordrhein-westfalen
city: Essen
country: Germany
facility: Kliniken Essen Mitte / Knappschaftskrankenhaus
state: Nordrhein-westfalen
city: Moenchengladbach
country: Germany
facility: Augentagesklinik Maria-Hilf Krankenhaus
state: Nordrhein-westfalen
city: Moenchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH - Franziskuskrankenhaus
state: Nordrhein-westfalen
city: Moenchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH; Klinik fuer Radiologie
state: Nordrhein-westfalen
city: Neuss
country: Germany
facility: Lukaskrankenhaus Neuss; Zentrale Apotheke
state: Nordrhein-westfalen
city: Bochum
country: Germany
facility: Institut f. Pathologie - Ruhr-Universitaet Bochum, Prof. Dr. med. Andrea Tannapfel
state: North Rhine Westfalia
city: Worms
country: Germany
facility: Augenarzt Praxis Dr. med. Petra Huelsmann
state: Rheinland-pfalz
city: Worms
country: Germany
facility: Gemeinschaftspraxis fuer Radiologie und Nuklearmedizin, Standort Worms
state: Rheinland-pfalz
city: Worms
country: Germany
facility: Martin Apotheke
state: Rheinland-pfalz
city: Worms
country: Germany
facility: Onkologische Schwerpunktpraxis Worms
state: Rheinland-pfalz
city: Worms
country: Germany
facility: Praxisgemeinschaft Kruse + Hofstaetter
state: Rheinland-pfalz
city: Berlin
country: Germany
facility: Evangelisches Waldkrankenhaus Spandau
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf, Klinik fuer Augenheilkunde
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf, Zentrum fuer Radiologie und Endoskopie
city: Hamburg
country: Germany
facility: ZytoService Deutschland GmbH, Standort-Hamburg-Jenfeld
city: Hamburg
country: Germany
facility: HKS Kardiologische Praxis am Israelitischen Krankenhaus
city: Hamburg
country: Germany
facility: Radiologie im Israelitischen Krankenhaus
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz - Onkologiai Osztaly
state: Zala
city: Budapest
country: Hungary
facility: Szent Margit Kórház
city: Budapest
country: Hungary
facility: Eszak-Pesti Centrumkorhaz-Honvedkorhaz
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center - Oncology
state: NAP
city: Ashkelon
country: Israel
facility: The Barzilai Medical Center - Oncology Institute
city: Be'er-Sheva
country: Israel
facility: Soroka University Medical Center
city: Bnei Brak
country: Israel
facility: MOR Institute
city: Jerusalem
country: Israel
facility: Ein-Karem Department of Medical Imaging of Hadassah Medical Organization, Hadassah Medical Center,
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
city: Jerusalem
country: Israel
facility: Pharmacy of Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
city: Jerusalem
country: Israel
facility: Mt. Scopus Department of Medical Imaging of Hadassah Medical Organization,
city: Kfar Saba
country: Israel
facility: Imaging Department of Meir Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Pharmacy of Rabin Medical Center, Beilinson Hospital
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Torrette Di Ancona
country: Italy
facility: Ospedali Riuniti Umberto I
state: Ancona
city: Treviglio
country: Italy
facility: ASST Bergamo Ovest, Ospedale Treviglio Caravaggio di Trevigl
state: Bergamo
city: Bergamo
country: Italy
facility: Oculistica, ASST Papa Giovanni XXIII
state: BG
city: Bergamo
country: Italy
facility: Oncologia, ASST Papa Giovanni XXIII
state: BG
city: Monserrato
country: Italy
facility: Clinica di Oncologia Medica AOU di Cagliari Presidio Duilio Casula Monserrato
state: Cagliari
city: Monserrato
country: Italy
facility: Farmacia AOU di Cagliari Presidio Duilio Casula Monserrato
state: Cagliari
city: Monserrato
country: Italy
facility: Radiologia AOU di Cagliari Presidio Duilio Casula Monserrato
state: Cagliari
city: Cremona
country: Italy
facility: Oculistica - ASST Cremona, Ospedale di Cremona
state: CR
city: Cremona
country: Italy
facility: SC Farmacia Aziendale - ASST Cremona, Ospedale di Cremona
state: CR
city: Cremona
country: Italy
facility: SC Oncologia - ASST Cremona, Ospedale di Cremona
state: CR
city: Rozzano
country: Italy
facility: U.O. Oculistica, Istituto Clinico HUMANITAS
state: Milano
city: Rozzano (MI)
country: Italy
facility: U.O. di Oncologia ed Ematologia, Istituto Clinico HUMANITAS
state: Milan
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele - U.O. di Medicina Oncologica
state: MI
city: Milano
country: Italy
facility: Servizio di Farmacia - IRCCS Ospedale San Raffaele
state: MI
city: Milano
country: Italy
facility: S.C. Radiologia diagnostica e interventistica - Fondazione IRCCS Istituto Nazionale dei Tumori
state: MI
city: Milano
country: Italy
facility: SC Oncologia Medica 1, SS Oncologia Medica Gastroenterologica
state: MI
city: Padova
country: Italy
facility: Cardiologia per i pazienti oncologici - Istituto Oncologico Veneto I.R.C.C.S
state: PD
city: Padova
country: Italy
facility: Clinica Oculistica - Azienda Ospedaliera di Padova
state: PD
city: Padova
country: Italy
facility: U.O. Oncologia Medica 1 - Istituto Oncologico Veneto I.R.C.C.S
state: PD
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi, AOU di Bologna - Oncologia Medica
city: Cagliari
country: Italy
facility: Divisione Anatomia Patologica Presidio San Giovanni di Dio
city: Cagliari
country: Italy
facility: Oculistica AOU di Cagliari Presidio San Giovanni di Dio
city: Firenze
country: Italy
facility: Dipartimento Neuromuscoloscheletrico e Organi di Senso, "Oncologia Oculare Unit"
city: Firenze
country: Italy
facility: SC oncologia Medica I - Azienda Ospedaliero Universitaria Careggi
city: Milano
country: Italy
facility: Radiologia
city: Milano
country: Italy
facility: Unita di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini
city: Milano
country: Italy
facility: Grande Ospedale Metropolitano Niguarda
city: Modena
country: Italy
facility: Dipartimento Interaziendale Farmaceutico - AOU Policlinico di Modena
city: Modena
country: Italy
facility: SC di Oftalmologia - AOU Policlinico di Modena
city: Modena
country: Italy
facility: SC di Radiologia, Dipartimento Interaziendale integrato Diagnostica per Immagini
city: Modena
country: Italy
facility: SSD Day Hospital Oncologico - Dipartimento ad attivita integrata di Oncologia, Ematologia
city: Napoli
country: Italy
facility: AOU Universita degli Studi della Campania L. Vanvitelli - DAI di Medicina Interna e Specialistica
city: Napoli
country: Italy
facility: AOU Universita degli Studi della Campania L. Vanvitelli - U. Ma.Ca.
city: Napoli
country: Italy
facility: AOU Universita degli Studi della Campania L. Vanvitelli
city: Napoli
country: Italy
facility: AOU Universita degli Studi della Campania L. Vanvitelli
city: Pisa
country: Italy
facility: UO Oculistica - AOU Pisana, Stabilimento Ospedaliero di Cisanello
city: Pisa
country: Italy
facility: SOD Radiodiagnostica 3 - AOU Pisana, Stabilimento Ospedaliero di Santa Chiara
city: Pisa
country: Italy
facility: UO Farmaceutica, Gestione del Farmaco - AOU Pisana, Stabilimento Ospedaliero di Santa Chiara
city: Pisa
country: Italy
facility: UO Oncologia Medica 2 - AOU Pisana, Stabilimento Ospedaliero di Santa Chiara
city: Roma
country: Italy
facility: U.O.S.D. Oncologia Medica, Dipartimento di Medicina - Fondazione PTV Policlinico Tor Vergata
city: Roma
country: Italy
facility: U.O.S.D. Patologie Retiniche - Fondazione PTV Policlinico Tor Vergata
city: Nagoya
country: Japan
facility: Chayagasaka Eye Clinic
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Tsukahara Eye Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Suita
country: Japan
facility: Osaka University Hospital Laboratory for Clinical Investigation
state: Osaka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggido
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital IRB
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Delegacion Cuauhtemoc
country: Mexico
facility: Superare Centro de Infusion S.A. de C.V.
state: Ciudad DE Mexico
city: Ciudad de Mexico
country: Mexico
facility: Consultorio dentro de la Torre Medica Dalinde (Oncologia Medica)
state: Cuauhtemoc
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital Arnhem
state: Gelderland
city: Velp
country: Netherlands
facility: Rijnstate Hospital Velp
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center (MUMC)
state: Limburg
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
state: Noord-holland
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwen Gasthuis
state: Noord-holland
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
state: Zuid-holland
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Lommedalen
country: Norway
facility: Colosseum Øyelegesenter C/O LB Holdings AS
city: Oslo
country: Norway
facility: Colosseum Øyelegesenter C/O LB Holdings AS
city: Oslo
country: Norway
facility: Oslo universitetssykehus, Radiumhospitalet
city: Oslo
country: Norway
facility: Sykehusapoteket Oslo, Radiumhospitalet
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony, Oddzial Onkologiczny
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. L. Rydygiera w Krakowie Sp.z.o.o.
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
city: Poznan
country: Poland
facility: NZOZ Centrum Medyczne HCP
city: Poznan
country: Poland
facility: NZOZ Przychodnia Specjalistyczna GUTMED
city: Warszawa
country: Poland
facility: MAGODENT Sp. z o.o. Szpital Elblaska
city: Kursk
country: Russian Federation
facility: Regional Budgetary Healthcare Institution Kursk Regional Clinical
state: Kursk Region
city: Chelyabinsk
country: Russian Federation
facility: Evimed Llc
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution "N.N. Blokhin Russian Cancer Research Center" of the
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution "N.N. Blokhin Russian Cancer Research Center"
city: Obninsk
country: Russian Federation
facility: A. Tsyb Medical Radiological Research Center - branch of the
city: Sankt-Petersburg
country: Russian Federation
facility: State Budgetary Educational Institution of Higher Professional Education First Saint Petersburg
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen
state: Andalucia
city: Jaen
country: Spain
facility: Sercosa - Clinica de las Nieves
state: Andalucia
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Baleares
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Catala d'Oncologia
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli
state: Barcelona
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía
state: Cordona
city: Madrid
country: Spain
facility: Hospital Nuestra Señora del Rosario
state: Madrid, Communidad Delaware
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
state: Tarragona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Clinica Corachan
city: Barcelona
country: Spain
facility: Hospital Quiron Salud Barcelona
city: Barcelona
country: Spain
facility: Cetir Centre Medic S.L.
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Cordoba
country: Spain
facility: Consulta Dr. Juan Carlos Castillo Dominguez
city: Madrid
country: Spain
facility: Gabinete Radiologico Dr. Pita
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital HM Universitario Sanchinarro
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Clinica Oftalvist
city: Valencia
country: Spain
facility: Fundacion Instituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Quiron Salud Zaragoza
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Changhua city
country: Taiwan
facility: Changhua Christian Hospital
state: Changhua County
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan city
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
state: Bornova
city: Izmir
country: Turkey
facility: Izmir Medical Park Hospital - Medical Oncology
state: Izmir, Karsiyaka
city: Istanbul
country: Turkey
facility: Medeniyet University Goztepe Training and Research Hospital
state: Kadikoy
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Bursa
country: Turkey
facility: Uludag University Hospital
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi
city: Malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal Medical Center
city: Dnipropetrovsk
country: Ukraine
facility: Oftalmolohycheskyi tsentr "Vzghliad" MTs
state: Dnipropetrovska Oblast'
city: Dnipropetrovsk
country: Ukraine
facility: Oftalmolohycheskyi tsentr "Vzghliad" MTs
state: Dnipropetrovska Oblast'
city: Dnipropetrovsk
country: Ukraine
facility: Derzhavnyi zaklad, Dnipropetrovska medychna akademiia Ministerstva okhorony zdorovia Ukrainy
state: Dnipropetrovska Oblast'
city: Dnipropetrovsk
country: Ukraine
facility: Komumalnyi zaklad, Dnipropetrovska miska bahatoprofilna klinichna likarnia Nº4
state: Dnipropetrovska Oblast'
city: Kyiv
country: Ukraine
facility: Kyivska klinichna likarnia na zaliznychnomu transporti No3 filii Tsentr okhorony zdorov'ia PAT
state: Kyivska Oblast'
city: Kyiv
country: Ukraine
facility: Natsionalnyi medychnyi universytet imeni O.O Bohomltsia, kafedra onkolohii
state: Kyivska Oblast'
city: Kyiv
country: Ukraine
facility: Natsionalnyi medychnyi universytet imeni O.O Bohomltsia, kafedra oftalmolohii
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Oleksandrivska klinichna likarnia mista Kyieva
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Kyivskyi miskyi klinichnyi onkotsentr
state: Kyivska Oblast
city: Vinnytsia
country: Ukraine
facility: Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser, viddilennia khimioterapii
state: Vinnyts'ka Oblast'
city: Uzhgorod
country: Ukraine
facility: DVNZ "Uzhhorodskyi natsionalnyi universytet"
state: Zakarpats'ka Oblast'
city: Uzhgorod
country: Ukraine
facility: Tsentralna miska klinichna likarnia, Miskyi onkolohichnyi tsentr
state: Zakarpats'ka Oblast'
city: Uzhhorod
country: Ukraine
facility: DVNZ "Uzhhorodskyi natsionalnyi universytet"
state: Zakarpatska Oblast
city: Uzhhorod
country: Ukraine
facility: TOV "Zakarpatskyi Tsentr Mikrokhirurhii Oka"
state: Zakarpatska Oblast
city: Aberdeen
country: United Kingdom
facility: NHS Grampian - Aberdeen Royal Infirmary
state: Aberdeenshire Scotland
city: Windsor
country: United Kingdom
facility: King Edward V11 Hospital
state: Berkshire
city: Glasglow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
state: Glasglow City, Scotland
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital
state: WEST Midlands
city: London
country: United Kingdom
facility: Hammersmith Hospital, Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust, Charing Cross Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust - Christie Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.