A Study Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer.
NCT ID: NCT05004350
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
107 participants
INTERVENTIONAL
2021-09-14
2024-12-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Encorafenib and cetuximab
Safety Lead-in (SLI) phase:
28 day cycles of encorafenib once daily (QD) 300 mg (4 x 75 mg oral capsule) and cetuximab 400 mg/m² initial dose (120-minute infusion), then 250 mg/m² (60-minute infusion) thereafter once weekly
Randomized (Phase II) phase:
28 day cycles of encorafenib once daily (QD) 300 mg (4 x 75 mg oral capsule) and cetuximab 400 mg/m² initial dose (120-minute infusion), then 250 mg/m² (60-minute infusion) thereafter once weekly
Encorafenib
oral hard capsule
Cetuximab
intravenous infusion
Irinotecan and cetuximab or FOLFIRI and cetuximab
Randomized (Phase II) phase: Either irinotecan and cetuximab or FOLFIRI and cetuximab in 28 day cycles.
Irinotecan and cetuximab:
* irinotecan 180 mg/m² (90-minute intravenous infusion or to study site standards) every 2 weeks and
* cetuximab 400 mg/m² initial dose (120-minute intravenous infusion), then 250 mg/m² (60-minute infusion) thereafter once weekly
OR
FOLFIRI and cetuximab:
* irinotecan 180 mg/m² (90-minute intravenous infusion or to study site standards) every 2 weeks
* Folinic acid 400 mg/m² (120-minute infusion or to study site standards) or maximal dose tolerated in a prior regimen every 2 weeks
* 5-FU 400 mg/m² initial dose bolus (not to exceed 15 minutes), then 1200 mg/m²/day × 2 days (total 2400 mg/m² over 46 to 48 hours) continuous infusion or maximal dose tolerated in a prior regimen every 2 weeks and
* cetuximab 400 mg/m² initial dose (120-minute intravenous infusion), then 250 mg/m² (60-minute infusion) thereafter once weekly
Encorafenib
oral hard capsule
Cetuximab
intravenous infusion
FOLFIRI
Combination of:
irinotecan ( also known as: Camptosar, Camptothecin-11 and CPT-11) intravenous infusion, folinic acid (also known as: 5-formyl tetrahydrofolic acid and leucovorin) intravenous infusion, and 5-FU (also known as; fluorouracil) intravenous bolus/intravenous infusion
Interventions
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Encorafenib
oral hard capsule
Cetuximab
intravenous infusion
FOLFIRI
Combination of:
irinotecan ( also known as: Camptosar, Camptothecin-11 and CPT-11) intravenous infusion, folinic acid (also known as: 5-formyl tetrahydrofolic acid and leucovorin) intravenous infusion, and 5-FU (also known as; fluorouracil) intravenous bolus/intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically- or cytologically-confirmed colorectal cancer (CRC) that is metastatic.
* Eligible to receive cetuximab per Chinese approved label with regard to tumor Rat Sarcoma Viral Oncogene Homologue (RAS) mutation status (i.e. approved for Rat Sarcoma Viral Oncogene Homologue Wild Type(RAS wt) status).
* Able to provide a sufficient amount of representative tumor specimen for central prospective laboratory testing of B-RAF Proto-oncogene, Serine/threonine Kinase (BRAF) mutation status and also retrospective RAS wt status and Microsatellite Instability (MSI) testing.
* Chinese male or female participant with age ≥18 years at time of informed consent.
* Histologically or cytologically confirmed CRC that is metastatic and unresectable at time of study entry (i.e. not suitable for complete surgical resection at screening).
* Presence of a BRAF V600E mutation in tumor tissue previously determined by a local assay at any time before screening or by the central laboratory.
Exclusion Criteria
* Prior anti-Epidermal Growth Factor Receptor (anti-EGFR) treatment
* More than two prior regimens in the metastatic setting.
* Known contraindication to receive cetuximab or irinotecan at the planned dose according to the most recent cetuximab and irinotecan local label.
* Known history of Gilbert's syndrome or is known to have any of the following genotypes: uridine 5'-diphospho-glucuronosyltransferase (UGT)1A1\*6/\*6, UGT1A1\*28/\*28 or UGT1A1\*6/\*28.
* Leptomeningeal disease.
* Prior treatment with any Proto oncogene Serine/threonine-Protein Kinase (RAF) inhibitor, cetuximab, panitumumab or other EGFR inhibitors.
* Symptomatic brain metastasis.
* Leptomeningeal disease.
* Use of any herbal medications/supplements or any medications or foods that are moderate or strong inhibitors or inducers of cytochrome P450 (CYP)3A4/5 ≤1 week before the start of study intervention.
* Known history of acute or chronic pancreatitis within 6 months before the start of study intervention.
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Principal Investigators
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Shen Lin, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fujian Medical University - Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital Sun Yat-Sen University
Guangzhou, Guangdong, China
Cancer Hospital Affiliated to Shantou University Medical College
Shantou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The Affiliated Hospital of Hebei University
Baoding, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Tongji medical college Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affilliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai East Hospital, Tongji University
Shanghai, Shanghai Municipality, China
The Second People's Hospital of Neijiang
Neijiang, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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W00090GE202
Identifier Type: -
Identifier Source: org_study_id
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