Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2026-05-08 @ 10:42 AM
Study NCT ID:
NCT03224767
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2017-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003397', 'term': 'Craniopharyngioma'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077484', 'term': 'Vemurafenib'}, {'id': 'C574276', 'term': 'cobimetinib'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2017-07-19', 'studyFirstSubmitQcDate': '2017-07-20', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'Up to 5 years', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Up to 5 years', 'description': 'Will be summarized for each cohort within each cohort with Kaplan-Meier curves and estimates.'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 5 years', 'description': 'Will be summarized for each cohort within each cohort with Kaplan-Meier curves and estimates.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['BRAF V600E Mutation Present', 'Papillary Craniopharyngioma']}, 'referencesModule': {'references': [{'pmid': '37437144', 'type': 'DERIVED', 'citation': 'Brastianos PK, Twohy E, Geyer S, Gerstner ER, Kaufmann TJ, Tabrizi S, Kabat B, Thierauf J, Ruff MW, Bota DA, Reardon DA, Cohen AL, De La Fuente MI, Lesser GJ, Campian J, Agarwalla PK, Kumthekar P, Mann B, Vora S, Knopp M, Iafrate AJ, Curry WT Jr, Cahill DP, Shih HA, Brown PD, Santagata S, Barker FG 2nd, Galanis E. BRAF-MEK Inhibition in Newly Diagnosed Papillary Craniopharyngiomas. N Engl J Med. 2023 Jul 13;389(2):118-126. doi: 10.1056/NEJMoa2213329.'}, {'pmid': '32086697', 'type': 'DERIVED', 'citation': 'Rutenberg MS, Rotondo RL, Rao D, Holtzman AL, Indelicato DJ, Huh S, Morris CG, Mendenhall WM. Clinical outcomes following proton therapy for adult craniopharyngioma: a single-institution cohort study. J Neurooncol. 2020 Apr;147(2):387-395. doi: 10.1007/s11060-020-03432-9. Epub 2020 Feb 21.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the activity of BRAF and MEK inhibitor combination in untreated papillary craniopharyngiomas as measured by best response at any time during the first four cycles of BRAF and MEK inhibitor treatment.\n\nII. To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas that have progressed after prior radiation treatment with or without surgical resection as measured by best response at any time during the first four cycles of BRAF and MEK inhibitor treatment.\n\nSECONDARY OBJECTIVES:\n\nI. To determine the progression-free survival of patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors.\n\nII. To determine the toxicity of BRAF/MEK inhibitors in patients with papillary craniopharyngiomas.\n\nIII. To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas as measured by response of enhancing volume of craniopharyngioma.\n\nIV. To determine the activity of BRAF and MEK inhibitor combination in papillary craniopharyngiomas as measured by response of nonenhancing volume of craniopharyngioma.\n\nV. To determine the overall survival of patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors.\n\nVI. To determine the duration of response in patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors.\n\nTERTIARY OBJECTIVES:\n\nI. To evaluate visual fields in patients with papillary craniopharyngiomas who have received BRAF/MEK inhibitors.\n\nII. To evaluate pituitary hormone replacement over time in patients with papillary craniopharyngiomas who have received BRAF/MEK inhibitors.\n\nIII. To evaluate the time to response in patients with papillary craniopharyngiomas receiving BRAF and MEK inhibitors.\n\nIV. To assess toxicity that may be associated with radiotherapy in patients with papillary craniopharyngiomas who have received BRAF/MEK inhibitors.\n\nV. To evaluate molecular biomarkers of response in papillary craniopharyngiomas.\n\nVI. To evaluate circulating tumor cells and cell-free circulating deoxyribonucleic acid (DNA) in patients with papillary craniopharyngiomas.\n\nOUTLINE:\n\nPatients receive vemurafenib orally (PO) twice daily (BID) on day 1-28 and cobimetinib PO once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive radiation therapy, surgery, or continued treatment with vemurafenib and cobimetinib at the discretion of the treating physician.\n\nAfter completion of study treatment, patients with disease progression are followed up every 16 weeks for 2 years and all other patients are followed up every 6 months for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* 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\n* Histologically proven papillary craniopharyngioma as documented by central pathology review with positive BRAF V600E mutation by IHC\n* Measurable disease and/or non-measurable disease\n\n * 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\n * 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.\n* Prior treatment\n\n * Cohort A: No prior therapy received other than surgery\n * Cohort B: Prior radiation therapy required (any type of prior radiation is allowed)\n\n * 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\n * Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity attributed to radiation with exception of alopecia, fatigue\n * For patients enrolling on Cohort A or Cohort B:\n\n * For patients treated with surgery, an interval of \\>= 21 days must have elapsed prior to registration\n * No prior treatment with BRAF or MEK inhibitors\n * Steroid dosing stable for at least 4 days prior to registration\n* Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =\\< 7 days prior to registration is required\n* ECOG performance status =\\< 2\n* Comorbid conditions\n\n * No evidence of active bleeding, bleeding diathesis, or hemoptysis (\\>= 1/2 teaspoon of red blood) =\\< 8 weeks prior to registration\n * No evidence of intracranial hemorrhage =\\< 4 weeks prior to registration\n * 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\n * No symptomatic congestive heart failure (New York Heart Association class II, III, or IV) within 6 months prior to registration\n * No current unstable angina or uncontrolled arrhythmia\n * No uncontrolled hypertension at time of registration (blood pressure \\[BP\\] \\> 150/95 despite antihypertensive therapy)\n * No known history of prolonged QT syndrome\n * No known history of ventricular arrhythmia within 6 months of registration\n * No known history of uveitis or iritis =\\< 4 weeks prior to registration\n * 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\n * No known history of chronic lung disease\n* Concomitant medications\n\n * 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\n * Chronic concomitant treatment with CYP1A2 substrate is not allowed; patients must discontinue the drug at least 14 days prior to study registration\n* Absolute neutrophil count \\>= 1500/mm\\^3\n* Platelets \\>= 100,000/mm\\^3\n* Creatinine =\\< 1.5 mg/dL OR creatinine clearance \\>= 45mL/min\n* Bilirubin =\\< 1.5 upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\\< 2.5 ULN'}, 'identificationModule': {'nctId': 'NCT03224767', 'briefTitle': 'Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas', 'orgStudyIdInfo': {'id': 'A071601'}, 'secondaryIdInfos': [{'id': 'NCI-2017-00740', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trial Reporting Program'}, {'id': 'U10CA180821', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180821', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (vemurafenib, cobimetinib)', 'description': 'Patients receive vemurafenib PO BID on day 1-28 and cobimetinib PO QD on days 1-21. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive radiation therapy, surgery, or continued treatment with vemurafenib and cobimetinib at the discretion of the treating physician.', 'interventionNames': ['Drug: Vemurafenib', 'Drug: Cobimetinib', 'Other: Laboratory Biomarker Analysis', 'Other: Quality-of-Life Assessment']}], 'interventions': [{'name': 'Vemurafenib', 'type': 'DRUG', 'description': 'Given PO', 'armGroupLabels': ['Treatment (vemurafenib, cobimetinib)']}, {'name': 'Cobimetinib', 'type': 'DRUG', 'description': 'Given PO', 'armGroupLabels': ['Treatment (vemurafenib, cobimetinib)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (vemurafenib, cobimetinib)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Treatment (vemurafenib, cobimetinib)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '95603', 'city': 'Auburn', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Centers Radiation Oncology Services-Auburn', 'geoPoint': {'lat': 38.89657, 'lon': -121.07689}}, {'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center-Herrick Campus', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '94010', 'city': 'Burlingame', 'state': 'California', 'country': 'United States', 'facility': 'Mills-Peninsula Medical Center', 'geoPoint': {'lat': 37.5841, 'lon': -122.36608}}, {'zip': '95682', 'city': 'Cameron Park', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Centers Radiation Oncology Services-Cameron Park', 'geoPoint': {'lat': 38.66879, 'lon': -120.98716}}, {'zip': '94546', 'city': 'Castro Valley', 'state': 'California', 'country': 'United States', 'facility': 'Eden Hospital Medical Center', 'geoPoint': {'lat': 37.6941, 'lon': -122.08635}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95355', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Memorial Medical Center', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation-Camino Division', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Health/Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'country': 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'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49017', 'city': 'Battle Creek', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bronson Battle Creek', 'geoPoint': {'lat': 42.3173, 'lon': -85.17816}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Corewell Health Grand Rapids Hospitals - Butterworth Hospital', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': "Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital", 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': 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