Testando a adição de um medicamento anticâncer, Cabozantinib ao Cemiplimab de drogas de imunoterapia (REGN2810), em adolescentes e adultos com câncer adrenocortical avançado
Um estudo de Fase II do Cabozantinib em combinação com o cemiplimab (Cabo-cemiplimab) versus o Cabozantinib sozinho em adolescentes e adultos com câncer adrenocortico avançado
This phase II trial compares the effect of giving cabozantinib with or without cemiplimab in patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), and that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib with cemiplimab may kill more tumor cells in patients with locally advanced unresectable or recurrent/metastatic adrenocortical cancer.
Visão geral do estudo
Status
Condições
Descrição detalhada
PRIMARY OBJECTIVE:
I. To determine whether the combination of cabozantinib plus cemiplimab (REGN2810) (Cabo-Cemiplimab [REGN2810]) improves progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 relative to cabozantinib alone in patients with locally advanced unresectable or recurrent/metastatic advanced adrenocortical cancer.
SECONDARY OBJECTIVES:
I. To assess tolerability and adverse events of Cabo-Cemiplimab (REGN2810) in advanced adrenocortical cancer (ACC) patients.
II. To assess objective response rate as per RECIST v 1.1. III. To assess duration of objective response, time to progression (TTP), and overall survival (OS) in ACC patients receiving Cabo-Cemiplimab (REGN2810).
EXPLORATORY OBJECTIVE:
I. To assess PFS from re-registration (per RECIST 1.1) and OS for patients who crossover to receive Cabo-Cemiplimab after progressing on cabozantinib alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive cabozantinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) and blood sample collection throughout the study. Upon disease progression, patients may elect to crossover to receive combination therapy on Arm B.
ARM B: Patients receive cemiplimab intravenously (IV) over 30 minutes on day 1 and cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 12 weeks until disease progression and then every 6 months for 4 years post-registration.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Arizona
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Phoenix, Arizona, Estados Unidos, 85054
- Recrutamento
- Mayo Clinic Hospital in Arizona
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Contato:
- Site Public Contact
- Número de telefone: 855-776-0015
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Investigador principal:
- Julie E. Hallanger Johnson
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California
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La Jolla, California, Estados Unidos, 92093
- Recrutamento
- UC San Diego Moores Cancer Center
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Contato:
- Site Public Contact
- Número de telefone: 858-822-5354
- E-mail: cancercto@ucsd.edu
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Investigador principal:
- Yu-Wei Chen
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Madera, California, Estados Unidos, 93636
- Recrutamento
- Valley Children's Hospital
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Contato:
- Site Public Contact
- Número de telefone: 559-353-3000
- E-mail: Research@valleychildrens.org
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Investigador principal:
- Ruetima Titapiwatanakun
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Recrutamento
- UCHealth University of Colorado Hospital
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Investigador principal:
- Laura Graham
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Contato:
- Site Public Contact
- Número de telefone: 720-848-0650
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Florida
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Jacksonville, Florida, Estados Unidos, 32224-9980
- Recrutamento
- Mayo Clinic in Florida
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Contato:
- Site Public Contact
- Número de telefone: 855-776-0015
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Investigador principal:
- Julie E. Hallanger Johnson
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Recrutamento
- Lurie Children's Hospital-Chicago
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Contato:
- Site Public Contact
- Número de telefone: 773-880-4562
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Investigador principal:
- Elizabeth A. Sokol
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Chicago, Illinois, Estados Unidos, 60611
- Recrutamento
- Northwestern University
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Investigador principal:
- Mary F. Mulcahy
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Contato:
- Site Public Contact
- Número de telefone: 312-695-1301
- E-mail: cancer@northwestern.edu
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Danville, Illinois, Estados Unidos, 61832
- Recrutamento
- Carle at The Riverfront
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Investigador principal:
- Priyank P. Patel
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Contato:
- Site Public Contact
- Número de telefone: 800-446-5532
- E-mail: Research@Carle.com
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DeKalb, Illinois, Estados Unidos, 60115
- Recrutamento
- Northwestern Medicine Cancer Center Kishwaukee
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Investigador principal:
- Mary F. Mulcahy
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Contato:
- Site Public Contact
- Número de telefone: 630-352-5360
- E-mail: Donald.Smith3@nm.org
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Effingham, Illinois, Estados Unidos, 62401
- Recrutamento
- Carle Physician Group-Effingham
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Contato:
- Site Public Contact
- Número de telefone: 800-446-5532
- E-mail: Research@carle.com
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Investigador principal:
- Priyank P. Patel
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Geneva, Illinois, Estados Unidos, 60134
- Recrutamento
- Northwestern Medicine Cancer Center Delnor
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Investigador principal:
- Mary F. Mulcahy
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Contato:
- Site Public Contact
- Número de telefone: 630-352-5360
- E-mail: Donald.Smith3@nm.org
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Glenview, Illinois, Estados Unidos, 60026
- Recrutamento
- Northwestern Medicine Glenview Outpatient Center
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Investigador principal:
- Mary F. Mulcahy
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Contato:
- Site Public Contact
- Número de telefone: 312-695-1102
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Grayslake, Illinois, Estados Unidos, 60030
- Recrutamento
- Northwestern Medicine Grayslake Outpatient Center
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Investigador principal:
- Mary F. Mulcahy
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Contato:
- Site Public Contact
- Número de telefone: 312-695-1102
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Lake Forest, Illinois, Estados Unidos, 60045
- Recrutamento
- Northwestern Medicine Lake Forest Hospital
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Investigador principal:
- Mary F. Mulcahy
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Contato:
- Site Public Contact
- E-mail: cancertrials@northwestern.edu
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Mattoon, Illinois, Estados Unidos, 61938
- Recrutamento
- Carle Physician Group-Mattoon/Charleston
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Contato:
- Site Public Contact
- Número de telefone: 800-446-5532
- E-mail: Research@carle.com
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Investigador principal:
- Priyank P. Patel
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Normal, Illinois, Estados Unidos, 61761
- Recrutamento
- Carle BroMenn Medical Center
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Investigador principal:
- Priyank P. Patel
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Contato:
- Site Public Contact
- Número de telefone: 800-446-5532
- E-mail: Research@Carle.com
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Normal, Illinois, Estados Unidos, 61761
- Recrutamento
- Carle Cancer Institute Normal
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Investigador principal:
- Priyank P. Patel
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Contato:
- Site Public Contact
- Número de telefone: 800-446-5532
- E-mail: Research@Carle.com
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Oak Brook, Illinois, Estados Unidos, 60523
- Recrutamento
- Northwestern Medicine Oak Brook
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Investigador principal:
- Mary F. Mulcahy
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Contato:
- Site Public Contact
- E-mail: nctnprogram_rhlccc@northwestern.edu
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Orland Park, Illinois, Estados Unidos, 60462
- Recrutamento
- Northwestern Medicine Orland Park
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Investigador principal:
- Mary F. Mulcahy
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Contato:
- Site Public Contact
- E-mail: nctnprogram_rhlccc@northwestern.edu
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Shiloh, Illinois, Estados Unidos, 62269
- Recrutamento
- Memorial Hospital East
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Contato:
- Site Public Contact
- Número de telefone: 314-747-9912
- E-mail: dschwab@wustl.edu
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Investigador principal:
- Nikolaos Trikalinos
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Urbana, Illinois, Estados Unidos, 61801
- Recrutamento
- Carle Cancer Center
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Contato:
- Site Public Contact
- Número de telefone: 800-446-5532
- E-mail: Research@carle.com
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Investigador principal:
- Priyank P. Patel
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Warrenville, Illinois, Estados Unidos, 60555
- Recrutamento
- Northwestern Medicine Cancer Center Warrenville
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Investigador principal:
- Mary F. Mulcahy
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Contato:
- Site Public Contact
- Número de telefone: 630-352-5360
- E-mail: Donald.Smith3@nm.org
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Iowa
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Ankeny, Iowa, Estados Unidos, 50023
- Recrutamento
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
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Contato:
- Site Public Contact
- Número de telefone: 515-241-3305
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Investigador principal:
- Seema Harichand-Herdt
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Carroll, Iowa, Estados Unidos, 51401
- Recrutamento
- Saint Anthony Regional Hospital
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Contato:
- Site Public Contact
- Número de telefone: 515-689-7658
- E-mail: sbenson@iora.org
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Investigador principal:
- Seema Harichand-Herdt
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Clive, Iowa, Estados Unidos, 50325
- Recrutamento
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Contato:
- Site Public Contact
- Número de telefone: 515-241-3305
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Investigador principal:
- Seema Harichand-Herdt
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Des Moines, Iowa, Estados Unidos, 50314
- Recrutamento
- Broadlawns Medical Center
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Contato:
- Site Public Contact
- Número de telefone: 515-282-2200
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Investigador principal:
- Seema Harichand-Herdt
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Des Moines, Iowa, Estados Unidos, 50314
- Recrutamento
- Mercy Medical Center - Des Moines
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Contato:
- Site Public Contact
- Número de telefone: 515-241-3305
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Investigador principal:
- Richard L. Deming
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Des Moines, Iowa, Estados Unidos, 50309
- Recrutamento
- Iowa Methodist Medical Center
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Contato:
- Site Public Contact
- Número de telefone: 515-241-6727
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Investigador principal:
- Seema Harichand-Herdt
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Des Moines, Iowa, Estados Unidos, 50309
- Recrutamento
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Contato:
- Site Public Contact
- Número de telefone: 515-241-3305
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Investigador principal:
- Seema Harichand-Herdt
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Des Moines, Iowa, Estados Unidos, 50314
- Recrutamento
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Contato:
- Site Public Contact
- Número de telefone: 515-241-3305
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Investigador principal:
- Seema Harichand-Herdt
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Fort Dodge, Iowa, Estados Unidos, 50501
- Recrutamento
- UI Healthcare Mission Cancer and Blood - Fort Dodge
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Investigador principal:
- Seema Harichand-Herdt
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Contato:
- Site Public Contact
- Número de telefone: 515-282-2921
- E-mail: trials@missioncancer.com
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Waukee, Iowa, Estados Unidos, 50263
- Recrutamento
- UI Health Care Mission Cancer and Blood - Waukee Clinic
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Contato:
- Site Public Contact
- Número de telefone: 515-241-3305
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Investigador principal:
- Seema Harichand-Herdt
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Recrutamento
- Dana-Farber Cancer Institute
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Investigador principal:
- Stephanie A. Berg
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Contato:
- Site Public Contact
- Número de telefone: 877-442-3324
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- Recrutamento
- University of Michigan Rogel Cancer Center
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Investigador principal:
- Francis P. Worden
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Contato:
- Site Public Contact
- Número de telefone: 800-865-1125
- E-mail: CancerAnswerLine@med.umich.edu
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Recrutamento
- Mayo Clinic in Rochester
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Contato:
- Site Public Contact
- Número de telefone: 855-776-0015
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Investigador principal:
- Julie E. Hallanger Johnson
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Missouri
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City of Saint Peters, Missouri, Estados Unidos, 63376
- Recrutamento
- Siteman Cancer Center at Saint Peters Hospital
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Contato:
- Site Public Contact
- Número de telefone: 800-600-3606
- E-mail: info@siteman.wustl.edu
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Investigador principal:
- Nikolaos Trikalinos
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Creve Coeur, Missouri, Estados Unidos, 63141
- Recrutamento
- Siteman Cancer Center at West County Hospital
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Contato:
- Site Public Contact
- Número de telefone: 800-600-3606
- E-mail: info@siteman.wustl.edu
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Investigador principal:
- Nikolaos Trikalinos
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Kansas City, Missouri, Estados Unidos, 64108
- Recrutamento
- Children's Mercy Hospitals and Clinics
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Investigador principal:
- Keith J. August
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Contato:
- Site Public Contact
- Número de telefone: 816-302-6808
- E-mail: COGResearchGroup@cmh.edu
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Springfield, Missouri, Estados Unidos, 65807
- Recrutamento
- CoxHealth South Hospital
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Investigador principal:
- Jay W. Carlson
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Contato:
- Site Public Contact
- Número de telefone: 417-269-4520
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St Louis, Missouri, Estados Unidos, 63110
- Recrutamento
- Washington University School of Medicine
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Contato:
- Site Public Contact
- Número de telefone: 800-600-3606
- E-mail: info@siteman.wustl.edu
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Investigador principal:
- Nikolaos Trikalinos
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St Louis, Missouri, Estados Unidos, 63129
- Recrutamento
- Siteman Cancer Center-South County
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Contato:
- Site Public Contact
- Número de telefone: 800-600-3606
- E-mail: info@siteman.wustl.edu
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Investigador principal:
- Nikolaos Trikalinos
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St Louis, Missouri, Estados Unidos, 63136
- Recrutamento
- Siteman Cancer Center at Christian Hospital
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Contato:
- Site Public Contact
- Número de telefone: 800-600-3606
- E-mail: info@siteman.wustl.edu
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Investigador principal:
- Nikolaos Trikalinos
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Nebraska
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Bellevue, Nebraska, Estados Unidos, 68123
- Recrutamento
- Nebraska Medicine-Bellevue
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Contato:
- Site Public Contact
- Número de telefone: 402-559-6941
- E-mail: unmcrsa@unmc.edu
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Investigador principal:
- Apar Kishor Ganti
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Omaha, Nebraska, Estados Unidos, 68198
- Recrutamento
- University of Nebraska Medical Center
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Contato:
- Site Public Contact
- Número de telefone: 402-559-6941
- E-mail: unmcrsa@unmc.edu
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Investigador principal:
- Apar Kishor Ganti
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Omaha, Nebraska, Estados Unidos, 68118
- Recrutamento
- Nebraska Medicine-Village Pointe
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Contato:
- Site Public Contact
- Número de telefone: 402-559-5600
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Investigador principal:
- Apar Kishor Ganti
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New Jersey
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Basking Ridge, New Jersey, Estados Unidos, 07920
- Recrutamento
- Memorial Sloan Kettering Basking Ridge
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Contato:
- Site Public Contact
- Número de telefone: 212-639-7592
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Investigador principal:
- Nitya P. Raj
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Middletown, New Jersey, Estados Unidos, 07748
- Recrutamento
- Memorial Sloan Kettering Monmouth
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Contato:
- Site Public Contact
- Número de telefone: 212-639-7592
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Investigador principal:
- Nitya P. Raj
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Montvale, New Jersey, Estados Unidos, 07645
- Recrutamento
- Memorial Sloan Kettering Bergen
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Contato:
- Site Public Contact
- Número de telefone: 212-639-7592
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Investigador principal:
- Nitya P. Raj
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New York
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Commack, New York, Estados Unidos, 11725
- Recrutamento
- Memorial Sloan Kettering Commack
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Contato:
- Site Public Contact
- Número de telefone: 212-639-7592
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Investigador principal:
- Nitya P. Raj
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Harrison, New York, Estados Unidos, 10604
- Recrutamento
- Memorial Sloan Kettering Westchester
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Contato:
- Site Public Contact
- Número de telefone: 212-639-7592
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Investigador principal:
- Nitya P. Raj
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New York, New York, Estados Unidos, 10065
- Recrutamento
- Memorial Sloan Kettering Cancer Center
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Contato:
- Site Public Contact
- Número de telefone: 212-639-7592
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Investigador principal:
- Nitya P. Raj
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Uniondale, New York, Estados Unidos, 11553
- Recrutamento
- Memorial Sloan Kettering Nassau
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Contato:
- Site Public Contact
- Número de telefone: 212-639-7592
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Investigador principal:
- Nitya P. Raj
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North Carolina
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Cary, North Carolina, Estados Unidos, 27518
- Suspenso
- Duke Cancer Center Cary
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Durham, North Carolina, Estados Unidos, 27710
- Recrutamento
- Duke University Medical Center
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Contato:
- Site Public Contact
- Número de telefone: 888-275-3853
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Investigador principal:
- Diane L. Reidy-lagunes
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Raleigh, North Carolina, Estados Unidos, 27609
- Recrutamento
- Duke Cancer Center Raleigh
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Contato:
- Site Public Contact
- E-mail: NCTNStudyTeam@dm.duke.edu
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Investigador principal:
- Diane L. Reidy-lagunes
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Recrutamento
- Ohio State University Comprehensive Cancer Center
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Contato:
- Site Public Contact
- Número de telefone: 800-293-5066
- E-mail: Jamesline@osumc.edu
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Investigador principal:
- Bhavana Konda
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Recrutamento
- University of Oklahoma Health Sciences Center
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Contato:
- Site Public Contact
- Número de telefone: 405-271-8777
- E-mail: ou-clinical-trials@ouhsc.edu
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Investigador principal:
- Adanma Anji Ayanambakkam Attanathi
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Recrutamento
- Children's Hospital of Pittsburgh of UPMC
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Contato:
- Site Public Contact
- Número de telefone: 412-692-8570
- E-mail: jean.tersak@chp.edu
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Investigador principal:
- Brittani K. Seynnaeve
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South Carolina
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Boiling Springs, South Carolina, Estados Unidos, 29316
- Recrutamento
- Prisma Health Cancer Institute - Spartanburg
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Investigador principal:
- Aniket Saha
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Contato:
- Site Public Contact
- Número de telefone: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Columbia, South Carolina, Estados Unidos, 29203
- Recrutamento
- Prisma Health Richland Hospital
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Investigador principal:
- Aniket Saha
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Contato:
- Site Public Contact
- Número de telefone: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Easley, South Carolina, Estados Unidos, 29640
- Recrutamento
- Prisma Health Cancer Institute - Easley
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Investigador principal:
- Aniket Saha
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Contato:
- Site Public Contact
- Número de telefone: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Greenville, South Carolina, Estados Unidos, 29605
- Recrutamento
- BI-LO Charities Children's Cancer Center
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Investigador principal:
- Aniket Saha
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Contato:
- Site Public Contact
- Número de telefone: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Greenville, South Carolina, Estados Unidos, 29605
- Recrutamento
- Prisma Health Cancer Institute - Faris
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Investigador principal:
- Aniket Saha
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Contato:
- Site Public Contact
- Número de telefone: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Greenville, South Carolina, Estados Unidos, 29605
- Recrutamento
- Prisma Health Cancer Institute - Butternut
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Investigador principal:
- Aniket Saha
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Contato:
- Site Public Contact
- Número de telefone: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Greenville, South Carolina, Estados Unidos, 29615
- Recrutamento
- Prisma Health Cancer Institute - Eastside
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Investigador principal:
- Aniket Saha
-
Contato:
- Site Public Contact
- Número de telefone: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Greer, South Carolina, Estados Unidos, 29650
- Recrutamento
- Prisma Health Cancer Institute - Greer
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Investigador principal:
- Aniket Saha
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Contato:
- Site Public Contact
- Número de telefone: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Seneca, South Carolina, Estados Unidos, 29672
- Recrutamento
- Prisma Health Cancer Institute - Seneca
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Investigador principal:
- Aniket Saha
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Contato:
- Site Public Contact
- Número de telefone: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38105
- Recrutamento
- Saint Jude Children's Research Hospital
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Contato:
- Site Public Contact
- Número de telefone: 888-226-4343
- E-mail: referralinfo@stjude.org
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Investigador principal:
- Catherine G. Lam
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Texas
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Austin, Texas, Estados Unidos, 78723
- Recrutamento
- Dell Children's Medical Center of Central Texas
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Contato:
- Site Public Contact
- Número de telefone: 512-628-1902
- E-mail: TXAUS-DL-SFCHemonc.research@ascension.org
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Investigador principal:
- Shannon M. Cohn
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Dallas, Texas, Estados Unidos, 75390
- Recrutamento
- UT Southwestern/Simmons Cancer Center-Dallas
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Contato:
- Site Public Contact
- Número de telefone: 214-648-7097
- E-mail: canceranswerline@UTSouthwestern.edu
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Investigador principal:
- Suzanne M. Cole
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Dallas, Texas, Estados Unidos, 75235
- Recrutamento
- Parkland Memorial Hospital
-
Contato:
- Site Public Contact
- Número de telefone: 214-590-5582
- E-mail: canceranswerline@UTSouthwestern.edu
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Investigador principal:
- Suzanne M. Cole
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Dallas, Texas, Estados Unidos, 75237
- Recrutamento
- UT Southwestern Simmons Cancer Center - RedBird
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Investigador principal:
- Suzanne M. Cole
-
Contato:
- Site Public Contact
- Número de telefone: 214-648-7097
- E-mail: canceranswerline@utsouthwestern.edu
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Fort Worth, Texas, Estados Unidos, 76104
- Recrutamento
- Cook Children's Medical Center
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Contato:
- Site Public Contact
- Número de telefone: 682-885-2103
- E-mail: CookChildrensResearch@cookchildrens.org
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Investigador principal:
- Kelly L. Vallance
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Fort Worth, Texas, Estados Unidos, 76104
- Recrutamento
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Contato:
- Site Public Contact
- Número de telefone: 214-648-7097
- E-mail: canceranswerline@UTSouthwestern.edu
-
Investigador principal:
- Suzanne M. Cole
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Richardson, Texas, Estados Unidos, 75080
- Recrutamento
- UT Southwestern Clinical Center at Richardson/Plano
-
Contato:
- Site Public Contact
- Número de telefone: 972-669-7044
- E-mail: Suzanne.cole@utsouthwestern.edu
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Investigador principal:
- Suzanne M. Cole
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San Antonio, Texas, Estados Unidos, 78207
- Recrutamento
- Children's Hospital of San Antonio
-
Contato:
- Site Public Contact
- Número de telefone: 210-704-2894
- E-mail: bridget.medina@christushealth.org
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Investigador principal:
- Julie Voeller
-
San Antonio, Texas, Estados Unidos, 78229
- Recrutamento
- University of Texas Health Science Center at San Antonio
-
Contato:
- Site Public Contact
- Número de telefone: 210-450-3800
- E-mail: phoresearchoffice@uthscsa.edu
-
Investigador principal:
- Aaron J. Sugalski
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23235
- Recrutamento
- VCU Massey Cancer Center at Stony Point
-
Contato:
- Site Public Contact
- E-mail: ctoclinops@vcu.edu
-
Investigador principal:
- Asit K. Paul
-
Richmond, Virginia, Estados Unidos, 23298
- Recrutamento
- VCU Massey Comprehensive Cancer Center
-
Investigador principal:
- Asit K. Paul
-
Contato:
- Site Public Contact
- Número de telefone: 804-628-6430
- E-mail: CTOclinops@vcu.edu
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98195
- Recrutamento
- University of Washington Medical Center - Montlake
-
Contato:
- Site Public Contact
- Número de telefone: 800-804-8824
-
Investigador principal:
- Keith D. Eaton
-
Seattle, Washington, Estados Unidos, 98109
- Recrutamento
- Fred Hutchinson Cancer Center
-
Contato:
- Site Public Contact
- Número de telefone: 800-804-8824
-
Investigador principal:
- Keith D. Eaton
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
-
STEP 1: Patients must have documented histologically or cytologically confirmed adrenocortical carcinoma
-
STEP 1: Locally advanced unresectable or recurrent/metastatic disease
-
STEP 1: Evaluable disease as defined by RECIST v 1.1
-
STEP 1: Up to 3 prior lines of systemic therapy will be allowed in the unresectable/recurrent/metastatic setting. Treatment naïve patients will be allowed.
- Note: Combination etoposide, doxorubicin, cisplatin, and mitotane (EDP-M) is considered 1 line of therapy. For patients who received mitotane ≤ 6 months prior to registration, mitotane should be discontinued 28 days prior to study registration AND a mitotane level must be documented to be < 2 mg/L prior to registration. Patients who have received mitotane within 6 months of enrollment and who have mitotane levels ≥ 2 mg/L will not be eligible to enroll
-
STEP 1: No prior treatment with cabozantinib or other cMET inhibitors, or anti-CTLA-4, or anti-PD-1/PD-L1 therapy
-
STEP 1: Prior external beam radiation therapy (any area radiated within a month prior to study registration cannot be used as an index lesion and only growth outside of the radiation field can be considered for disease progression), systemic cytotoxic chemotherapy, targeted therapies will be allowed, as long as not administered within 14 days before study registration, and provided any acute treatment-related associated toxicities have recovered to ≤ grade 1 except for alopecia, peripheral neuropathy or other residual toxicities that are not deemed clinically significant
-
STEP 1: Potential trial participants should have recovered from clinically significant adverse events, and wound healing is clinically adequate of their most recent therapy/intervention prior to enrollment
-
STEP 1: Age 12 years and above; and BSA ≥ 1.2m^2
-
STEP 1:
- Eastern Cooperative Oncology Group (ECOG) performance 0 - 2 (age 18 and above); or
- Patients 12 to <16 years of age will be assessed by the Lansky scale and should have a score ≥ 50; or
- Patients ≥ 16 to <18 years of age will be assessed by the Karnofsky scale, and should have a score ≥ 50
-
STEP 1: Absolute neutrophil count (ANC) ≥ 1,000/mcL without colony stimulating factor support within 2 weeks prior
- Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory
-
STEP 1: Platelet count ≥ 100,000/mcL
- Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory
-
STEP 1: Hemoglobin ≥ 8 g/dL
- Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory
-
STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- For patients with known Gilbert's disease, bilirubin ≤ 3 mg/dL
-
STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x upper limit of normal (ULN)
-
STEP 1: Random Urine Creatinine Ratio (UPCR) ≤ 1 mg/mg
-
STEP 1: Calculated (Calc.) creatinine clearance ≥ 30 mL/min
-
STEP 1: Mitotane level < 2 mg/L*
- Only applicable for patients who have received mitotane ≤ 6 months prior to registration
-
STEP 1: Must have assessment of adrenal steroid production within 3 months prior to registration as patients will be stratified based on corticosteroid production
- Patients will be classified as corticosteroid producing if random plasma adrenocorticotropic hormone (ACTH) is < 20 pg/mL plus random serum cortisol is > 20 mcg/dL in the absence of anti-cortisol therapy. Patients already on anti-cortisol therapy will be classified as having corticosteroid producing tumors regardless of their plasma ACTH and serum cortisol levels, as these levels can be affected by anti-cortisol therapy
-
STEP 1: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects based on animal reproduction studies. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test, per institution standard, done ≤ 14 days prior to registration is required
-
STEP 1: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional within 28 days of registration. To be eligible for this trial, patients should be class II or better
-
STEP 1: No known history of congenital long QT syndrome
-
STEP 1: No known history of myocarditis
-
STEP 1: No myocardial infarction (MI) or unstable angina within 6 months of registration
-
STEP 1: No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 6 months of registration including, but not limited to: active peptic ulcer, known endoluminal metastatic lesion(s) with history of bleeding, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation
-
STEP 1: No history of gastrointestinal (GI) perforation within 6 months of registration
-
STEP 1: No known tumor with invasion into the GI tract from the outside causing increased risk of perforation or bleeding within 28 days of registration
-
STEP 1: No current radiologic or clinical evidence of pancreatitis
-
STEP 1: No history of clinically significant non-healing wounds or ulcers within 28 days of registration
-
STEP 1: No uncontrolled hypertension within 14 days of registration (defined as sustained systolic blood pressure (SBP) ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg despite optimal medical management)
-
STEP 1: No known endobronchial lesions involving the main or lobar bronchi and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage. (CT with contrast is recommended to evaluate such lesions.). No hemoptysis greater than ½ teaspoon (2.5 mL) or any other signs of pulmonary hemorrhage within the 3 months prior to registration
-
STEP 1: No history of pneumonitis
-
STEP 1: No known tumor invading or encasing any major blood vessels
-
STEP 1: No history of fracture within 28 days of registration
-
STEP 1: No known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks after major surgery (e.g., removal or biopsy of brain metastasis) before registration. Eligible patients must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment
-
STEP 1: Major surgery (e.g., laparoscopic nephrectomy, GI surgery, within 2 weeks before registration. Minor surgeries within 10 days before registration. Patients with clinically relevant ongoing complications from prior surgery are not eligible
-
STEP 1: Verbalizes the ability to swallow oral tablet formulation
-
STEP 1: No history of allergic reaction attributed to compounds of similar chemical or biological composition to cabozantinib
-
STEP 1: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen will be eligible
-
STEP 1: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
-
STEP 1: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
-
STEP 1: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
-
STEP 1: No active autoimmune disease: or history of autoimmune disease that might recur, and which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of:
- immune related neurologic disease,
- multiple sclerosis,
- autoimmune (demyelinating) neuropathy,
- Guillain-Barre syndrome (GBS), myasthenia gravis,
- systemic autoimmune disease such as systemic lupus erythematosus (SLE),
- connective tissue diseases,
- scleroderma, inflammatory bowel disease (IBD),
- Crohn's, ulcerative colitis,
- patients with a history of toxic epidermal necrolysis (TEN),
- Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease,
- Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible,
- Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome, and psoriasis controlled with topical medication and patients with only positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies, should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
-
STEP 1: No steroid use > 10 mg prednisone equivalents daily. A brief course of corticosteroids for prophylaxis or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as is steroid pre-medication for contrast allergy
-
STEP 1: Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
-
STEP 1: Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
-
STEP 1: Herbal supplements and traditional Chinese medicines are not allowed
-
STEP 1: Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration. Allowed use of anticoagulants include: prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, apixaban. Also use of anticoagulants is allowed in patients with known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
-
STEP 2 (CROSSOVER): Patients must have demonstrated radiographic progression of disease on cabozantinib monotherapy (Arm A) per RECIST version 1.1 criteria
- Patients must cross-over to Arm C within 4 weeks (+/- 1 week) after radiographic documented progression and do not need to have a repeat radiographic assessment prior to starting cabozantinib and cemiplimab (REGN2810). The progression CT may serve as eligibility for crossover and as the baseline tumor measurement
-
STEP 2 (CROSSOVER): Patients that were discontinued on cabozantinib, or currently meet criteria for discontinuation of cabozantinib due to toxicity are not eligible to cross-over.
- Note: Patients who underwent dose reduction of cabozantinib during treatment on Arm A will not re-escalate dose at or after cross-over to Cabo-Cemiplimab (REGN2810) (Arm B)
-
STEP 2 (CROSSOVER): 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 serum or urine pregnancy test done ≤ 14 days prior to re-registration is required
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Arm A (cabozantinib)
Patients receive cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and blood sample collection throughout the study. Upon disease progression, patients may elect to crossover to receive combination therapy on Arm B. |
Undergo blood sample collection
Outros nomes:
Undergo MRI
Outros nomes:
Undergo CT scan
Outros nomes:
Given PO |
|
Experimental: Arm B (cabozantinib and cemiplimab)
Patients receive cemiplimab IV over 30 minutes on day 1 and cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and blood sample collection throughout the study. |
Undergo blood sample collection
Outros nomes:
Undergo MRI
Outros nomes:
Undergo CT scan
Outros nomes:
Given PO Given IV
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression free survival (PFS)
Prazo: From registration to either progression or death, assessed up to 4 years post-registration
|
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Will be analyzed using an intention-to-treat approach. Kaplan-Meier methodology will be used to estimate the distributions for the treatment arms. The hazard ratio, median PFS, and estimated PFS rates at 5, 10 and 15 months will be estimated along with corresponding 95% confidence intervals. A one-sided log rank-test will be used to compare the PFS distributions between the two treatment arms. |
From registration to either progression or death, assessed up to 4 years post-registration
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of adverse events
Prazo: Up to 4 years post-registration
|
Adverse events will be recorded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 for each patient. Frequency tables and summary statistics will be used and with the appropriate methods of evaluating categorical and continuous data. |
Up to 4 years post-registration
|
|
Objective response rate
Prazo: Up to 4 years post-registration
|
Will be assessed based on RECIST 1.1 criteria and will be summarized by treatment arm. will be calculated as the number of patients who achieve a response (partial response, complete response) divided by the total number of patients randomized to the corresponding treatment arm. A contingency table comparing treatment arms and responders to non-responders will be generated and a Fisher's exact test with a p-value cutoff of 0.05 will be used for determining whether evidence of a significant association between treatment and response is found. |
Up to 4 years post-registration
|
|
Duration of response
Prazo: From first date of the patient achieving either a complete or partial response and progression (via RECIST v 1.1), assessed up to 4 years post-registration
|
Kaplan-Meier methodology will be used to estimate the distributions of duration of response and a log-rank test between treatment arm will be calculated with corresponding p-value. |
From first date of the patient achieving either a complete or partial response and progression (via RECIST v 1.1), assessed up to 4 years post-registration
|
|
Time to progression
Prazo: From registration date and progression date, assessed up to 4 years post-registration
|
Kaplan-Meier methodology will be used to estimate the distributions of time to progression. |
From registration date and progression date, assessed up to 4 years post-registration
|
|
Overall survival
Prazo: From registration to death, assessed up to 4 years post-registration
|
Kaplan-Meier methodology will be used to estimate the distributions of overall survival. |
From registration to death, assessed up to 4 years post-registration
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Median PFS for patients who cross over
Prazo: From re-registration to progression or death, assessed up to 4 years post-registration
|
Calculated with corresponding 95% confidence interval. |
From re-registration to progression or death, assessed up to 4 years post-registration
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bhavana Konda, Alliance for Clinical Trials in Oncology
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Neoplasias por local
- Neoplasias
- Neoplasias por Tipo Histológico
- Neoplasias das Glândulas Endócrinas
- Neoplasias Glandulares e Epiteliais
- Adenocarcinoma
- Carcinoma
- Neoplasias do córtex adrenal
- Neoplasias da Glândula Adrenal
- Doenças do córtex adrenal
- Doenças da Glândula Adrenal
- Carcinoma Adrenocortical
- Técnicas de investigação
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Técnicas de química, analíticas
- Análise de espectro
- Manipulação de amostras
- Espectroscopia de ressonância magnética
- Cabozantinib
- cemiplimab
Outros números de identificação do estudo
- NCI-2025-02021
- U10CA180821 (Concessão/Contrato do NIH dos EUA)
- NCI-2025-02021 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- A092204 (Outro identificador: CTEP)
- A092204 (Outro identificador: Alliance for Clinical Trials in Oncology)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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Informações sobre medicamentos e dispositivos, documentos de estudo
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produto fabricado e exportado dos EUA
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