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 (BEACON CRC)
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ClinicalTrials.gov Identifier: NCT02928224 |
Recruitment Status :
Active, not recruiting
First Posted : October 10, 2016
Results First Posted : July 14, 2020
Last Update Posted : March 16, 2022
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
BRAF V600E-mutant Metastatic Colorectal Cancer |
Interventions |
Drug: Encorafenib Drug: Binimetinib Drug: Cetuximab Drug: Irinotecan Drug: Folinic Acid Drug: 5-Fluorouracil |
Enrollment | 702 |
Recruitment Details | Patients were at least 18 years of age with confirmed metastatic colorectal cancer (CRC) whose disease had progressed after 1 or 2 prior regimens in the metastatic setting and whose tumor tissue was BRAF V600E-mutant as previously determined by a local assay at any time prior to Screening |
Pre-assignment Details |
Arm/Group Title | Combined Safety Lead-in | Phase 3: Triplet Arm | Phase 3: Doublet Arm | Phase 3:Control Arm |
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Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care. |
Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care. |
Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care. |
Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. |
Period Title: Overall Study | ||||
Started | 37 | 224 | 220 | 221 |
Completed | 0 | 0 | 0 | 0 |
Not Completed | 37 | 224 | 220 | 221 |
Reason Not Completed | ||||
Randomized, Not Treated | 0 | 2 | 4 | 28 |
Treatment Ongoing | 6 | 78 | 78 | 37 |
Progressive Disease | 23 | 104 | 101 | 103 |
Adverse Event | 2 | 11 | 11 | 10 |
Changes in Patient's Condition | 3 | 9 | 9 | 13 |
Death | 1 | 7 | 5 | 11 |
Withdrawal by Subject | 1 | 4 | 3 | 9 |
Dose Interruptions>28 | 1 | 2 | 2 | 4 |
Patient Decision to Discontinue Drug | 0 | 2 | 2 | 4 |
Physician Decision | 0 | 2 | 4 | 2 |
not listed | 0 | 3 | 1 | 0 |
Arm/Group Title | Combined Safety Lead-in (CSLI) | Phase 3: Triplet Arm | Phase 3: Doublet Arm | Phase 3:Control Arm | Total | |
---|---|---|---|---|---|---|
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Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care. |
Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care. |
Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care. |
Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 37 | 224 | 220 | 221 | 702 | |
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The baseline analysis population consists of the Full Analysis Set (FAS). For patients in the CSLI, the FAS includes all patients who received at least 1 dose of study drug and had at least 1 post treatment assessment, which may include death. For the randomized Phase 3 portion of the study, the FAS consists of all randomized patients.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 37 participants | 224 participants | 220 participants | 221 participants | 702 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
23 62.2%
|
141 62.9%
|
137 62.3%
|
149 67.4%
|
450 64.1%
|
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>=65 years |
14 37.8%
|
83 37.1%
|
83 37.7%
|
72 32.6%
|
252 35.9%
|
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||||
Number Analyzed | 37 participants | 224 participants | 220 participants | 221 participants | 702 participants | |
58.3 (10.34) | 59.5 (11.65) | 60.2 (11.65) | 58.4 (12.07) | 59.3 (61) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 37 participants | 224 participants | 220 participants | 221 participants | 702 participants | |
Female |
22 59.5%
|
119 53.1%
|
105 47.7%
|
127 57.5%
|
373 53.1%
|
|
Male |
15 40.5%
|
105 46.9%
|
115 52.3%
|
94 42.5%
|
329 46.9%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 37 participants | 224 participants | 220 participants | 221 participants | 702 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
7 18.9%
|
20 8.9%
|
25 11.4%
|
39 17.6%
|
91 13.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
1 2.7%
|
2 0.9%
|
0 0.0%
|
0 0.0%
|
3 0.4%
|
|
White |
29 78.4%
|
195 87.1%
|
183 83.2%
|
172 77.8%
|
579 82.5%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
7 3.1%
|
12 5.5%
|
10 4.5%
|
29 4.1%
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Region
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 37 participants | 224 participants | 220 participants | 221 participants | 702 participants | |
North America |
5 13.5%
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30 13.4%
|
28 12.7%
|
29 13.1%
|
92 13.1%
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Europe |
25 67.6%
|
150 67.0%
|
145 65.9%
|
125 56.6%
|
445 63.4%
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Rest of World (includes Mexico) |
7 18.9%
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44 19.6%
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47 21.4%
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67 30.3%
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165 23.5%
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Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Baseline
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 37 participants | 224 participants | 220 participants | 221 participants | 702 participants | |
0-Fully active |
22 59.5%
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116 51.8%
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112 50.9%
|
108 48.9%
|
358 51.0%
|
|
1-Restircted in physically strenuous activity |
15 40.5%
|
108 48.2%
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104 47.3%
|
113 51.1%
|
340 48.4%
|
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2-Ambulatory and capable of all self-care |
0 0.0%
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0 0.0%
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4 1.8%
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0 0.0%
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4 0.6%
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[1]
Measure Description: ECOG PS was used to assess the physical health of patients, and ranges from 0 (most active) to 5 (dead). Frequency counts and percentages of patients in each score category were provided by treatment arm and assessment visit.
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Primary Tumor Location
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 37 participants | 224 participants | 220 participants | 221 participants | 702 participants | |
Left Colon |
11 29.7%
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79 35.3%
|
83 37.7%
|
68 30.8%
|
241 34.3%
|
|
Right Colon |
23 62.2%
|
126 56.3%
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110 50.0%
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119 53.8%
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378 53.8%
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Left and Right Colon |
0 0.0%
|
8 3.6%
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11 5.0%
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22 10.0%
|
41 5.8%
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Unknown |
3 8.1%
|
11 4.9%
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16 7.3%
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12 5.4%
|
42 6.0%
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Primary Tumor Removed
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 37 participants | 224 participants | 220 participants | 221 participants | 702 participants | |
Completely Resected |
20 54.1%
|
133 59.4%
|
123 55.9%
|
122 55.2%
|
398 56.7%
|
|
Partially Resected/Unresected |
17 45.9%
|
91 40.6%
|
97 44.1%
|
99 44.8%
|
304 43.3%
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Number of Organs Involved
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 37 participants | 224 participants | 220 participants | 221 participants | 702 participants | |
>=2 |
16 43.2%
|
114 50.9%
|
117 53.2%
|
123 55.7%
|
370 52.7%
|
|
>=3 |
21 56.8%
|
110 49.1%
|
103 46.8%
|
98 44.3%
|
332 47.3%
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Sites of Metastases
Measure Type: Number Unit of measure: Sites |
Number Analyzed | 37 participants | 224 participants | 220 participants | 221 participants | 702 participants |
Liver | 24 | 144 | 134 | 128 | 430 | |
Lung | 10 | 86 | 83 | 86 | 265 | |
Lymph Node | 17 | 86 | 82 | 88 | 273 | |
NodePeritoneum/Omentum | 17 | 77 | 97 | 93 | 284 |
Name/Title: | Study Director |
Organization: | Pfizer |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT02928224 |
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