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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05710406
Other study ID # A022004
Secondary ID NCI-2022-09129
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date May 30, 2023
Est. completion date August 2034

Study information

Verified date May 2024
Source Alliance for Clinical Trials in Oncology
Contact Rona Yaeger, MD
Phone 646-888-5109
Email yaegerr@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II/III trial compares treatment with encorafenib and cetuximab to usual care (patient observation) for reducing the chance of cancer recurrence after standard surgery and chemotherapy in patients with BRAF-mutated stage IIB-III colon cancer. Encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Giving encorafenib and cetuximab after standard surgery and chemotherapy may be more effective at reducing the chance of cancer recurrence compared to the usual patient observation.


Description:

The primary and secondary objectives of the study: PRIMARY OBJECTIVES: I. To evaluate and compare 6 month circulating tumor deoxyribonucleic acid (ctDNA) clearance rate in study patients with detectable ctDNA prior to randomization to targeted BRAF therapy versus usual care after standard adjuvant chemotherapy. (Phase II) II. To evaluate and compare 6 month ctDNA recurrence-free survival (ctDNA-RFS) rate in study patients with undetectable ctDNA prior to randomization to targeted BRAF therapy versus usual care after standard adjuvant chemotherapy. (Phase II) III. To evaluate and compare disease-free survival (DFS) (measured from randomization) in patients with resected stage III or high-risk (pT4) stage II mismatch repair protein (MMR) proficient BRAF V600E colon cancer treated with targeted BRAF therapy versus usual care after standard adjuvant chemotherapy. (Phase III) SECONDARY OBJECTIVES: I. To evaluate and compare overall survival (OS) between the two treatment arms. II. To evaluate and compare the toxicity profile between the two treatment arms. III. To evaluate and compare the alternative DFS endpoint (measured from date of primary tumor resection) between the two treatment arms. IV. To evaluate and compare DFS in the subset of patients with detectable ctDNA prior to randomization between the two treatment arms. EXPLORATORY OBJECTIVE: I. To evaluate and compare patient-reported outcomes for symptoms of rash, diarrhea, and fatigue according to Patient Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) between the two treatment arms. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive encorafenib orally (PO) and cetuximab intravenously (IV) on study. Patients also undergo collection of blood samples throughout the study and computed tomography (CT) or magnetic resonance imaging (MRI) during screening and follow-up. ARM II: Patients undergo observation per usual care on study. Patients also undergo collection of blood samples throughout the study and CT or MRI during screening and follow-up.


Recruitment information / eligibility

Status Recruiting
Enrollment 394
Est. completion date August 2034
Est. primary completion date August 2034
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - PRE-REGISTRATION (STEP 0) ELIGIBILITY CRITERIA: - BRAF V600 mutational status may be determined either locally or by central testing. This testing is mandatory prior to registration to determine eligibility. Tissue submission should be initiated as soon after surgery as possible. For tumors evaluated at local laboratories, formalin-fixed paraffin-embedded (FFPE) tumor tissue must still be submitted for central confirmation of BRAF status - REGISTRATION (STEP 1) ELIGIBILITY CRITERIA: - Histologically-proven stage III (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C) or high-risk (pT4) stage II colon adenocarcinoma. Tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel (e.g. those at the ileocecal valve) and must have been completely resected - BRAF V600E mutation - MMR proficient (pMMR) or microsatellite stable (MSS) tumor - Histologic documentation: adenocarcinoma - Stage: III (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C) or high-risk II (pT4) - Tumor site: colon - Patients must have received at least 3 months of adjuvant chemotherapy with either leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) (minimum of 5 cycles) or capecitabine and oxaliplatin (CAPOX) (minimum of 3 cycles) - Adjuvant therapy must be completed at most 8 weeks prior to registration - No other prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy) or radiation therapy for the current colon cancer is permitted - Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required - Age >= 18 years - Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 - Absolute neutrophil count (ANC) >= 1.0 x 10^9/L - Platelet count >= 75 x 10^9/L - Hemoglobin > 9.0 g/dL - Total bilirubin =< 1.5 x upper limit of normal (ULN) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x ULN - Corrected QT (QTc) Interval =< 480 msec - Creatinine = calculated (calc.) creatinine clearance >= 40 mL/min - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial - No medical condition such as uncontrolled infection, uncontrolled diabetes mellitus, or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient - Patients with known history or current symptoms of cardiac disease or history of treatment with cardiotoxic agents in the last 12 months, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better - No uncontrolled or poorly-controlled hypertension (> 180 mmHg systolic or > 130 mmHg diastolic) - No history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab - No "currently active" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for >= 3 years - Patients are not considered to have a "currently active" malignancy if they had a gastric or bowel carcinoid < 1 cm, ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS) of the breast without invasive cancer, or endometrial dysplasia/carcinoma in situ - Patients are not considered to have a "currently active" malignancy if they had a sebaceous neoplasm (sebaceous adenoma, sebaceous epithelioma, sebaceous adenocarcinoma, keratoacanthoma, and squamous cell carcinoma) that was noninvasive - No known medical condition causing an inability to swallow oral formulations of agents - No residual Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 grade >= 2 toxicity from prior chemotherapy, with the exception of grade 2 alopecia or neuropathy - Drugs that prolong the QTc interval should be avoided if possible, as encorafenib can prolong the QTc interval. Drugs that are generally accepted to have a risk of causing Torsades de Pointes should be discontinued or replaced with drugs that do not carry this risk if at all possible. Patients who receive potential QTc-prolonging medications should be monitored closely - Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed during treatment on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study - Chronic concomitant treatment with strong CYP3A4 inducers is not allowed during treatment on this study. Patients must discontinue the drug 14 days prior to registration on the study Exclusion Criteria: N/A

Study Design


Intervention

Drug:
Encorafenib
Given PO
Biological:
Cetuximab
Given IV
Procedure:
Biospecimen Collection
Undergo collection of blood samples
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Other:
Patient Observation
Undergo observation per usual care

Locations

Country Name City State
United States Hawaii Cancer Care - Westridge 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Community Hospital of Anaconda Anaconda Montana
United States Mission Cancer and Blood - Ankeny Ankeny Iowa
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States ThedaCare Regional Cancer Center Appleton Wisconsin
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States ThedaCare Cancer Care - Berlin Berlin Wisconsin
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Billings Clinic Cancer Center Billings Montana
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Trinity Health Medical Center - Brighton Brighton Michigan
United States Roswell Park Cancer Institute Buffalo New York
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Aultman Health Foundation Canton Ohio
United States Illinois CancerCare-Canton Canton Illinois
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Trinity Health Medical Center - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Illinois CancerCare-Carthage Carthage Illinois
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Miami Valley Hospital South Centerville Ohio
United States West Virginia University Charleston Division Charleston West Virginia
United States University of Virginia Cancer Center Charlottesville Virginia
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Northwestern University Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Memorial Sloan Kettering Commack Commack New York
United States Mercy Hospital Coon Rapids Minnesota
United States Northwest Cancer Center - Main Campus Crown Point Indiana
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern Simmons Cancer Center - RedBird Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Carle at The Riverfront Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Premier Blood and Cancer Center Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Illinois CancerCare-Dixon Dixon Illinois
United States Northwest Oncology LLC Dyer Indiana
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Swedish Cancer Institute-Edmonds Edmonds Washington
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Illinois CancerCare-Eureka Eureka Illinois
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas
United States Beebe South Coastal Health Campus Frankford Delaware
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Gibbs Cancer Center-Gaffney Gaffney South Carolina
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Glens Falls Hospital Glens Falls New York
United States Northwestern Medicine Glenview Outpatient Center Glenview Illinois
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Northwestern Medicine Grayslake Outpatient Center Grayslake Illinois
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Miami Valley Cancer Care and Infusion Greenville Ohio
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Memorial Sloan Kettering Westchester Harrison New York
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Northwest Cancer Center - Hobart Hobart Indiana
United States Saint Mary Medical Center Hobart Indiana
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States Cleveland Clinic Cancer Center Independence Independence Ohio
United States Saint Catherine Hospital Indianapolis Indiana
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Cleveland Clinic Cancer Center Mansfield Mansfield Ohio
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Aspirus Medford Hospital Medford Wisconsin
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Community Medical Center Missoula Montana
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States The Community Hospital Munster Indiana
United States Women's Diagnostic Center - Munster Munster Indiana
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States ThedaCare Regional Medical Center - Neenah Neenah Wisconsin
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States Memorial Sloan Kettering Cancer Center New York New York
United States Helen F Graham Cancer Center Newark Delaware
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Northwestern Medicine Orland Park Orland Park Illinois
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States Upstate Cancer Center at Oswego Oswego New York
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Illinois CancerCare-Princeton Princeton Illinois
United States Beebe Health Campus Rehoboth Beach Delaware
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States UT Southwestern Clinical Center at Richardson/Plano Richardson Texas
United States United Hospital Saint Paul Minnesota
United States Kootenai Cancer Clinic Sandpoint Idaho
United States North Coast Cancer Care Sandusky Ohio
United States Community Medical Center Scranton Pennsylvania
United States Swedish Medical Center-First Hill Seattle Washington
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States ThedaCare Cancer Care - Shawano Shawano Wisconsin
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Spartanburg Medical Center Spartanburg South Carolina
United States Memorial Medical Center Springfield Illinois
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Cleveland Clinic Cancer Center Strongsville Strongsville Ohio
United States State University of New York Upstate Medical University Syracuse New York
United States SUNY Upstate Medical Center-Community Campus Syracuse New York
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Upper Valley Medical Center Troy Ohio
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States MGC Hematology Oncology-Union Union South Carolina
United States Memorial Sloan Kettering Nassau Uniondale New York
United States Carle Cancer Center Urbana Illinois
United States Northwest Cancer Center - Valparaiso Valparaiso Indiana
United States Upstate Cancer Center at Verona Verona New York
United States South Pointe Hospital Warrensville Heights Ohio
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Illinois CancerCare - Washington Washington Illinois
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States ThedaCare Cancer Care - Waupaca Waupaca Wisconsin
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other • Patient Reported Outcomes Version of Common Terminology Criteria for Adverse Events for symptoms of rash, diarrhea, and fatigue summarized for each patient. up to 6 years
Primary Circulating tumor deoxyribonucleic acid (ctDNA) clearance rate (Phase II; ctDNA positive cohort) defined as the proportion of patients with undetectable ctDNA status at 6 months after randomization among patients with detectable ctDNA status at randomization. The ctDNA clearance rate at 6 months after randomization in experimental arm will be compared to control arm by Chi-squared test. The one-sided p-value will be reported. Due to small sample size, Cochran and Mantel-Haenszel test, stratified by stratification factors will be performed as sensitivity analysis. At 6 months after randomization
Primary tDNA recurrence-free survival rate (ctDNA-RFS) (Phase II; ctDNA negative cohort) Defined as the proportion of patients who remained undetectable ctDNA status, recurrence-free, and alive at 6 months after randomization among patients with undetectable ctDNA status at randomization. The ctDNA-RFS in experimental arm will be compared to control arm by Cochran and Mantel-Haenszel test, stratified by stratification factors. The one-sided p-value will be reported. at 6 months after randomization
Primary Disease free survival (DFS) (Phase III) Defined as the time from the date of randomization to the date of first documented recurrence or death due to all cause, whichever occurs first. Patients without events observed at the end of the study will be censored at the date of last disease evaluation which shows no evidence of disease. At each analysis (Interim #1, Interim #2, and Final), stratified Cox model will be conducted to compare DFS in the experimental arm to DFS in the control arm with stratification factors as stratum, based on all data collected at the analysis time point. Assessed up to 6 years after randomization
Secondary Overall Survival Defined as the time from the date of randomization to death due to all causes. The distributions of time-to-event endpoints will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model. Assessed up to 6 years
Secondary Incidence of adverse events after randomization The maximum grade for each type of adverse events that are possibly, probably, or definitely related to study treatments will be summarized for each patient. The frequency tables will be reviewed to determine the patterns. The overall adverse event rates for grade 4 or higher adverse events will be compared between two treatment groups using Chi-square test (or Fisher's exact test if the data in the contingency table is sparse). up to 6 years
Secondary Alternative disease free survival Defined as the time from the date of primary tumor resection to the date of first documented recurrence or death due to all cause, whichever occurs first. The distributions of time-to-event endpoints will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model. assessed up to 6 years
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