BRAF V600E Mutation Present Clinical Trial
Official title:
Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas
This phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | August 2026 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | - Pre-registration: Patients must have local diagnosis of papillary craniopharyngioma and have tissue slides available for submission to central pathology review; central pathology review will include immunohistochemistry (IHC) testing for BRAF V600E mutation (VE1 clone) and beta-catenin IHC (membranous, non-nuclear pattern) if needed to confirm diagnosis of papillary craniopharyngioma - Histologically proven papillary craniopharyngioma as documented by central pathology review with positive BRAF V600E mutation by IHC - Measurable disease and/or non-measurable disease - Measurable disease, defined as bidimensionally measurable lesions with clearly defined margins by magnetic resonance imaging (MRI) scans, with a minimum diameter of 10 mm in both dimensions - Progressive disease required in cohort B, defined as an increase in the bidirectional area by 25% within the past 13 months after surgery or radiation; progressive or recurrent disease is not required in cohort A, but is allowed provided it is a new diagnosis and patient has not received prior treatment. - Prior treatment - Cohort A: No prior therapy received other than surgery - Cohort B: Prior radiation therapy required (any type of prior radiation is allowed) - For patients treated with external beam radiation therapy, interstitial brachytherapy or radiosurgery, an interval of >= 3 months must have elapsed from completion of radiation therapy to registration - Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity attributed to radiation with exception of alopecia, fatigue - For patients enrolling on Cohort A or Cohort B: - For patients treated with surgery, an interval of >= 21 days must have elapsed prior to registration - No prior treatment with BRAF or MEK inhibitors - Steroid dosing stable for at least 4 days prior to registration - Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required - ECOG performance status =< 2 - Comorbid conditions - No evidence of active bleeding, bleeding diathesis, or hemoptysis (>= 1/2 teaspoon of red blood) =< 8 weeks prior to registration - No evidence of intracranial hemorrhage =< 4 weeks prior to registration - Patients who have experienced thromboembolic event within 6 months prior to registration must be on stable therapeutic anticoagulation for at least 4 weeks prior to registration - No symptomatic congestive heart failure (New York Heart Association class II, III, or IV) within 6 months prior to registration - No current unstable angina or uncontrolled arrhythmia - No uncontrolled hypertension at time of registration (blood pressure [BP] > 150/95 despite antihypertensive therapy) - No known history of prolonged QT syndrome - No known history of ventricular arrhythmia within 6 months of registration - No known history of uveitis or iritis =< 4 weeks prior to registration - No known history of or evidence of retinal pathology that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration within 12 months of registration - No known history of chronic lung disease - Concomitant medications - Chronic concomitant treatment with strong CYP3A4 inducers or CYP3A4 inhibitors is not allowed; patients must discontinue the drug at least 14 days prior to study registration - Chronic concomitant treatment with CYP1A2 substrate is not allowed; patients must discontinue the drug at least 14 days prior to study registration - Absolute neutrophil count >= 1500/mm^3 - Platelets >= 100,000/mm^3 - Creatinine =< 1.5 mg/dL OR creatinine clearance >= 45mL/min - Bilirubin =< 1.5 upper limit of normal (ULN) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 ULN |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California |
United States | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland |
United States | Bronson Battle Creek | Battle Creek | Michigan |
United States | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama |
United States | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
United States | Central Care Cancer Center - Bolivar | Bolivar | Missouri |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | Bozeman Deaconess Hospital | Bozeman | Montana |
United States | United Hospital Center | Bridgeport | West Virginia |
United States | Mills-Peninsula Medical Center | Burlingame | California |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Minnesota Oncology - Burnsville | Burnsville | Minnesota |
United States | Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho |
United States | Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California |
United States | Eden Hospital Medical Center | Castro Valley | California |
United States | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho |
United States | Mercy Hospital | Coon Rapids | Minnesota |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Inova Schar Cancer Institute | Fairfax | Virginia |
United States | Farmington Health Center | Farmington | Utah |
United States | Unity Hospital | Fridley | Minnesota |
United States | Central Care Cancer Center - Garden City | Garden City | Kansas |
United States | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan |
United States | Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan |
United States | Central Care Cancer Center - Great Bend | Great Bend | Kansas |
United States | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana |
United States | Great Falls Clinic | Great Falls | Montana |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Research Medical Center | Kansas City | Missouri |
United States | Cancer Centers of Southwest Oklahoma Research | Lawton | Oklahoma |
United States | Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire |
United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
United States | Fairview Clinics and Surgery Center Maple Grove | Maple Grove | Minnesota |
United States | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota |
United States | Saint John's Hospital - Healtheast | Maplewood | Minnesota |
United States | Idaho Urologic Institute-Meridian | Meridian | Idaho |
United States | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida |
United States | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Health Partners Inc | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Community Medical Hospital | Missoula | Montana |
United States | Memorial Medical Center | Modesto | California |
United States | Monticello Cancer Center | Monticello | Minnesota |
United States | West Virginia University Healthcare | Morgantown | West Virginia |
United States | Palo Alto Medical Foundation-Camino Division | Mountain View | California |
United States | Trinity Health Muskegon Hospital | Muskegon | Michigan |
United States | Saint Alphonsus Cancer Care Center-Nampa | Nampa | Idaho |
United States | Smilow Cancer Center/Yale-New Haven Hospital | New Haven | Connecticut |
United States | Yale University | New Haven | Connecticut |
United States | Cancer Center of Western Wisconsin | New Richmond | Wisconsin |
United States | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York |
United States | NYP/Weill Cornell Medical Center | New York | New York |
United States | Rutgers New Jersey Medical School | Newark | New Jersey |
United States | Corewell Health Lakeland Hospitals - Niles Hospital | Niles | Michigan |
United States | Cancer and Hematology Centers of Western Michigan - Norton Shores | Norton Shores | Michigan |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California |
United States | Palo Alto Medical Foundation Health Care | Palo Alto | California |
United States | Camden Clark Medical Center | Parkersburg | West Virginia |
United States | Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho |
United States | Corewell Health Reed City Hospital | Reed City | Michigan |
United States | North Memorial Medical Health Center | Robbinsdale | Minnesota |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California |
United States | Sutter Roseville Medical Center | Roseville | California |
United States | Sutter Medical Center Sacramento | Sacramento | California |
United States | Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center | Saint Joseph | Michigan |
United States | Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota |
United States | Regions Hospital | Saint Paul | Minnesota |
United States | United Hospital | Saint Paul | Minnesota |
United States | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah |
United States | California Pacific Medical Center-Pacific Campus | San Francisco | California |
United States | FHCC South Lake Union | Seattle | Washington |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | University of Washington Medical Center - Montlake | Seattle | Washington |
United States | Saint Francis Regional Medical Center | Shakopee | Minnesota |
United States | Welch Cancer Center | Sheridan | Wyoming |
United States | South Jordan Health Center | South Jordan | Utah |
United States | Lakeview Hospital | Stillwater | Minnesota |
United States | Palo Alto Medical Foundation-Sunnyvale | Sunnyvale | California |
United States | Tampa General Hospital | Tampa | Florida |
United States | Munson Medical Center | Traverse City | Michigan |
United States | Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut |
United States | Sutter Cancer Centers Radiation Oncology Services-Vacaville | Vacaville | California |
United States | Sutter Solano Medical Center/Cancer Center | Vallejo | California |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | Rice Memorial Hospital | Willmar | Minnesota |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
United States | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota |
United States | University of Michigan Health - West | Wyoming | Michigan |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | Defined as the number of responses achieved during treatment with BRAF and MEK inhibitors divided by the total number of evaluable patients and assessed by contrast-enhanced magnetic resonance imaging or computed tomography. Point estimates will be generated for response rates within each cohort with corresponding 95% binomial confidence intervals. Simon's two-stage design with one interim analysis for futility will be applied to evaluate response rate within each cohort. | Up to 5 years | |
Secondary | Progression-free survival | Will be summarized for each cohort within each cohort with Kaplan-Meier curves and estimates. | Up to 5 years | |
Secondary | Overall survival | Will be summarized for each cohort within each cohort with Kaplan-Meier curves and estimates. | Up to 5 years |
Status | Clinical Trial | Phase | |
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