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Report for Clinical Trial NCT03693170

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer

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

NCT03693170 BRAF V600E-mutant Metastatic Colorectal Cancer
MeSH:Colorectal Neoplasms
HPO:Neoplasm of the large intestine

3 Interventions

Name: encorafenib

Description: Once daily, orally
Type: Drug
Group Labels: 1

1 Arm

Name: Binimetinib

Description: Twice daily, orally
Type: Drug
Group Labels: 1

1 Arm

Name: Cetuximab

Description: Standard of care for the 28 first weeks and then every 2 weeks
Type: Drug
Group Labels: 1

1 Arm


Primary Outcomes

Description: Assessment of tumor evaluation change from baseline

Measure: Confirmed Overall Response Rate (cORR) based on local tumor assessments

Time: Duration of the study, approximately 25 months

Secondary Outcomes

Description: Percentage of subjects with complete response (CR) and partial response (PR)

Measure: Confirmed Overall Response Rate (cORR) based on central tumor assessment

Time: globally assessed by subject based on tumor evaluations every 6 weeks for the first 12 weeks and then every 8 weeks.

Description: Percentage of subjects with complete response (CR) and partial response (PR)

Measure: Overall response (ORR) based on local tumor assessments

Time: Globally assessed by subject based on tumor evaluations every 6 weeks for the first 12 weeks and then every 8 weeks.

Description: Percentage of subjects with complete response (CR) and partial response (PR)

Measure: Overall response (ORR) based on central tumor assessments

Time: Globally assessed by subject based on tumor evaluations every 6 weeks for the first 12 weeks and then every 8 weeks.

Description: Time from first radiographic evidence of response assessed based on local radiologist/investigator review to the earliest documented PD or death due to underlying disease

Measure: Duration of Response (DOR) per local assessment

Time: Duration of study approximately 25 months

Description: Time from first radiographic evidence of response review to the earliest documented PD or death due to underlying disease

Measure: Duration of Response (DOR) per central assessment

Time: Duration of study approximately 25 months

Description: Time from first dose until first documented radiographic evidence of response of CR or PR

Measure: Time to Response (TTR) per local review

Time: Duration of study approximately 25 months

Description: Time from first dose until first documented radiographic evidence of response of CR or PR

Measure: Time to Response (TTR) per central review

Time: Duration of study approximately 25 months

Description: Time from first dose to the earliest documented date of disease progression or death due to any cause

Measure: Progression of Free Survival (PFS) per local review

Time: Duration of study approximately 25 months

Description: Time from first dose to the earliest documented date of disease progression or death due to any cause

Measure: Progression of Free Survival (PFS) per central review

Time: Duration of study approximately 25 months

Description: Time from first dose to death due to any cause

Measure: Overall Survival (OS)

Time: Duration of study approximately 25 months

Measure: Safety through the incidence of adverse events

Time: Duration of study approximately 25 months

Description: Plasma concentration of encorafenib

Measure: Plasma concentration of encorafenib

Time: 2 hours and 6 hours after dose on Day 1 cycle 1; Predose and 2 hours post dose on Day 1 cycle 2 (cycle length = 28 days)

Description: Plasma concentration of binimetinib

Measure: Plasma concentration of binimetinib

Time: 2 hours and 6 hours after dose on Day 1 cycle 1; Predose and 2 hours post dose on Day 1 cycle 2 (cycle length = 28 days)

Description: Plasma concentration of cetuximab

Measure: Plasma concentration of cetuximab

Time: 2 hours and 6 hours after dose on Day 1 cycle 1; Predose and 2 hours post dose on Day 1 cycle 2 (cycle length = 28 days)

Description: Change in the Quality of Life Questionnaire for Cancer subjects.

Measure: Comparison of Quality of Life from Baseline to end of the study

Time: At screening, at Cycle 1 Day 1 and at the end of the study (each cycle is 28 days)

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer. --- V600E ---

Change in the Quality of Life Questionnaire for Cancer subjects.. Inclusion Criteria: - Male or female ≥ 18 years of age - Histologically or cytologically confirmed CRC that is metastatic - Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening and confirmed by central laboratory - Evidence of measurable disease as per RECIST, v1.1 - Subject able to receive cetuximab as per approved label with regards to RAS status - ECOG Status 0 or 1 - Adequate renal, hepatic, cardiac and bone marrow functions and adequate electrolytes as per protocol - Subject able to take oral medications Exclusion Criteria: - Prior systemic therapy for metastatic disease - Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab or other anti-EGFR inhibitors - Symptomatic brain metastasis or Leptomeningeal disease - History or current evidence of Retinal Vein Occlusion (RVO) or current risk factors for RVO - History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to first dose. --- V600E ---

- Impaired cardiovascular function or clinically significant cardiovascular diseases: history of myocardial infarction or coronary disorders within 6 months prior to start of study treatment, symptomatic congestive heart failure (grade 2 or higher), past or current clinically significant arrhythmia and/or conduction disorder within 6 months prior to study treatment start - History of thromboembolic or cerebrovascular events within 6 months prior to start of study treatment - Concurrent neuromuscular disorder that is associated with potential elevation of Creatine Kinase - Known contraindication to cetuximab administration as per SPC/approved label Inclusion Criteria: - Male or female ≥ 18 years of age - Histologically or cytologically confirmed CRC that is metastatic - Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening and confirmed by central laboratory - Evidence of measurable disease as per RECIST, v1.1 - Subject able to receive cetuximab as per approved label with regards to RAS status - ECOG Status 0 or 1 - Adequate renal, hepatic, cardiac and bone marrow functions and adequate electrolytes as per protocol - Subject able to take oral medications Exclusion Criteria: - Prior systemic therapy for metastatic disease - Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab or other anti-EGFR inhibitors - Symptomatic brain metastasis or Leptomeningeal disease - History or current evidence of Retinal Vein Occlusion (RVO) or current risk factors for RVO - History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to first dose. --- V600E ---

- Impaired cardiovascular function or clinically significant cardiovascular diseases: history of myocardial infarction or coronary disorders within 6 months prior to start of study treatment, symptomatic congestive heart failure (grade 2 or higher), past or current clinically significant arrhythmia and/or conduction disorder within 6 months prior to study treatment start - History of thromboembolic or cerebrovascular events within 6 months prior to start of study treatment - Concurrent neuromuscular disorder that is associated with potential elevation of Creatine Kinase - Known contraindication to cetuximab administration as per SPC/approved label BRAF V600E-mutant Metastatic Colorectal Cancer Colorectal Neoplasms The presence of a BRAFV600E mutation is considered a marker of poor prognosis in subjects with mCRC. --- V600E ---



HPO Nodes


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