Het testen van de toevoeging van een anti-kanker medicijn, cabozantinib aan de immunotherapie-geneesmiddelencemiplimab (REGN2810), bij adolescenten en volwassenen met geavanceerde adrenocorticale kanker
Een fase II-studie van cabozantinib in combinatie met cemiplimab (cabo-cemiplimab) versus cabozantinib alleen bij adolescenten en volwassenen met gevorderde adrenocorticale kanker
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85054
- Werving
- Mayo Clinic Hospital in Arizona
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Contact:
- Site Public Contact
- Telefoonnummer: 855-776-0015
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Hoofdonderzoeker:
- Julie E. Hallanger Johnson
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California
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La Jolla, California, Verenigde Staten, 92093
- Werving
- UC San Diego Moores Cancer Center
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Contact:
- Site Public Contact
- Telefoonnummer: 858-822-5354
- E-mail: cancercto@ucsd.edu
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Hoofdonderzoeker:
- Yu-Wei Chen
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Madera, California, Verenigde Staten, 93636
- Werving
- Valley Children's Hospital
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Contact:
- Site Public Contact
- Telefoonnummer: 559-353-3000
- E-mail: Research@valleychildrens.org
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Hoofdonderzoeker:
- Ruetima Titapiwatanakun
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- Werving
- UCHealth University of Colorado Hospital
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Hoofdonderzoeker:
- Laura Graham
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Contact:
- Site Public Contact
- Telefoonnummer: 720-848-0650
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Florida
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Jacksonville, Florida, Verenigde Staten, 32224-9980
- Werving
- Mayo Clinic in Florida
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Contact:
- Site Public Contact
- Telefoonnummer: 855-776-0015
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Hoofdonderzoeker:
- Julie E. Hallanger Johnson
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Werving
- Lurie Children's Hospital-Chicago
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Contact:
- Site Public Contact
- Telefoonnummer: 773-880-4562
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Hoofdonderzoeker:
- Elizabeth A. Sokol
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Chicago, Illinois, Verenigde Staten, 60611
- Werving
- Northwestern University
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Hoofdonderzoeker:
- Mary F. Mulcahy
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Contact:
- Site Public Contact
- Telefoonnummer: 312-695-1301
- E-mail: cancer@northwestern.edu
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Danville, Illinois, Verenigde Staten, 61832
- Werving
- Carle at The Riverfront
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Hoofdonderzoeker:
- Priyank P. Patel
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Contact:
- Site Public Contact
- Telefoonnummer: 800-446-5532
- E-mail: Research@Carle.com
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DeKalb, Illinois, Verenigde Staten, 60115
- Werving
- Northwestern Medicine Cancer Center Kishwaukee
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Hoofdonderzoeker:
- Mary F. Mulcahy
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Contact:
- Site Public Contact
- Telefoonnummer: 630-352-5360
- E-mail: Donald.Smith3@nm.org
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Effingham, Illinois, Verenigde Staten, 62401
- Werving
- Carle Physician Group-Effingham
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Contact:
- Site Public Contact
- Telefoonnummer: 800-446-5532
- E-mail: Research@carle.com
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Hoofdonderzoeker:
- Priyank P. Patel
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Geneva, Illinois, Verenigde Staten, 60134
- Werving
- Northwestern Medicine Cancer Center Delnor
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Hoofdonderzoeker:
- Mary F. Mulcahy
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Contact:
- Site Public Contact
- Telefoonnummer: 630-352-5360
- E-mail: Donald.Smith3@nm.org
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Glenview, Illinois, Verenigde Staten, 60026
- Werving
- Northwestern Medicine Glenview Outpatient Center
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Hoofdonderzoeker:
- Mary F. Mulcahy
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Contact:
- Site Public Contact
- Telefoonnummer: 312-695-1102
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Grayslake, Illinois, Verenigde Staten, 60030
- Werving
- Northwestern Medicine Grayslake Outpatient Center
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Hoofdonderzoeker:
- Mary F. Mulcahy
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Contact:
- Site Public Contact
- Telefoonnummer: 312-695-1102
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Lake Forest, Illinois, Verenigde Staten, 60045
- Werving
- Northwestern Medicine Lake Forest Hospital
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Hoofdonderzoeker:
- Mary F. Mulcahy
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Contact:
- Site Public Contact
- E-mail: cancertrials@northwestern.edu
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Mattoon, Illinois, Verenigde Staten, 61938
- Werving
- Carle Physician Group-Mattoon/Charleston
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Contact:
- Site Public Contact
- Telefoonnummer: 800-446-5532
- E-mail: Research@carle.com
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Hoofdonderzoeker:
- Priyank P. Patel
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Normal, Illinois, Verenigde Staten, 61761
- Werving
- Carle BroMenn Medical Center
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Hoofdonderzoeker:
- Priyank P. Patel
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Contact:
- Site Public Contact
- Telefoonnummer: 800-446-5532
- E-mail: Research@Carle.com
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Normal, Illinois, Verenigde Staten, 61761
- Werving
- Carle Cancer Institute Normal
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Hoofdonderzoeker:
- Priyank P. Patel
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Contact:
- Site Public Contact
- Telefoonnummer: 800-446-5532
- E-mail: Research@Carle.com
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Oak Brook, Illinois, Verenigde Staten, 60523
- Werving
- Northwestern Medicine Oak Brook
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Hoofdonderzoeker:
- Mary F. Mulcahy
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Contact:
- Site Public Contact
- E-mail: nctnprogram_rhlccc@northwestern.edu
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Orland Park, Illinois, Verenigde Staten, 60462
- Werving
- Northwestern Medicine Orland Park
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Hoofdonderzoeker:
- Mary F. Mulcahy
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Contact:
- Site Public Contact
- E-mail: nctnprogram_rhlccc@northwestern.edu
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Shiloh, Illinois, Verenigde Staten, 62269
- Werving
- Memorial Hospital East
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Contact:
- Site Public Contact
- Telefoonnummer: 314-747-9912
- E-mail: dschwab@wustl.edu
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Hoofdonderzoeker:
- Nikolaos Trikalinos
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Urbana, Illinois, Verenigde Staten, 61801
- Werving
- Carle Cancer Center
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Contact:
- Site Public Contact
- Telefoonnummer: 800-446-5532
- E-mail: Research@carle.com
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Hoofdonderzoeker:
- Priyank P. Patel
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Warrenville, Illinois, Verenigde Staten, 60555
- Werving
- Northwestern Medicine Cancer Center Warrenville
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Hoofdonderzoeker:
- Mary F. Mulcahy
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Contact:
- Site Public Contact
- Telefoonnummer: 630-352-5360
- E-mail: Donald.Smith3@nm.org
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Iowa
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Ankeny, Iowa, Verenigde Staten, 50023
- Werving
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
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Contact:
- Site Public Contact
- Telefoonnummer: 515-241-3305
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Hoofdonderzoeker:
- Seema Harichand-Herdt
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Carroll, Iowa, Verenigde Staten, 51401
- Werving
- Saint Anthony Regional Hospital
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Contact:
- Site Public Contact
- Telefoonnummer: 515-689-7658
- E-mail: sbenson@iora.org
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Hoofdonderzoeker:
- Seema Harichand-Herdt
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Clive, Iowa, Verenigde Staten, 50325
- Werving
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Contact:
- Site Public Contact
- Telefoonnummer: 515-241-3305
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Hoofdonderzoeker:
- Seema Harichand-Herdt
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Des Moines, Iowa, Verenigde Staten, 50314
- Werving
- Broadlawns Medical Center
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Contact:
- Site Public Contact
- Telefoonnummer: 515-282-2200
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Hoofdonderzoeker:
- Seema Harichand-Herdt
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Des Moines, Iowa, Verenigde Staten, 50314
- Werving
- Mercy Medical Center - Des Moines
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Contact:
- Site Public Contact
- Telefoonnummer: 515-241-3305
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Hoofdonderzoeker:
- Richard L. Deming
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Des Moines, Iowa, Verenigde Staten, 50309
- Werving
- Iowa Methodist Medical Center
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Contact:
- Site Public Contact
- Telefoonnummer: 515-241-6727
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Hoofdonderzoeker:
- Seema Harichand-Herdt
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Des Moines, Iowa, Verenigde Staten, 50309
- Werving
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Contact:
- Site Public Contact
- Telefoonnummer: 515-241-3305
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Hoofdonderzoeker:
- Seema Harichand-Herdt
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Des Moines, Iowa, Verenigde Staten, 50314
- Werving
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Contact:
- Site Public Contact
- Telefoonnummer: 515-241-3305
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Hoofdonderzoeker:
- Seema Harichand-Herdt
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Fort Dodge, Iowa, Verenigde Staten, 50501
- Werving
- UI Healthcare Mission Cancer and Blood - Fort Dodge
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Hoofdonderzoeker:
- Seema Harichand-Herdt
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Contact:
- Site Public Contact
- Telefoonnummer: 515-282-2921
- E-mail: trials@missioncancer.com
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Waukee, Iowa, Verenigde Staten, 50263
- Werving
- UI Health Care Mission Cancer and Blood - Waukee Clinic
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Contact:
- Site Public Contact
- Telefoonnummer: 515-241-3305
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Hoofdonderzoeker:
- Seema Harichand-Herdt
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Werving
- Dana-Farber Cancer Institute
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Hoofdonderzoeker:
- Stephanie A. Berg
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Contact:
- Site Public Contact
- Telefoonnummer: 877-442-3324
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- Werving
- University of Michigan Rogel Cancer Center
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Hoofdonderzoeker:
- Francis P. Worden
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Contact:
- Site Public Contact
- Telefoonnummer: 800-865-1125
- E-mail: CancerAnswerLine@med.umich.edu
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Werving
- Mayo Clinic in Rochester
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Contact:
- Site Public Contact
- Telefoonnummer: 855-776-0015
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Hoofdonderzoeker:
- Julie E. Hallanger Johnson
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Missouri
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City of Saint Peters, Missouri, Verenigde Staten, 63376
- Werving
- Siteman Cancer Center at Saint Peters Hospital
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Contact:
- Site Public Contact
- Telefoonnummer: 800-600-3606
- E-mail: info@siteman.wustl.edu
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Hoofdonderzoeker:
- Nikolaos Trikalinos
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Creve Coeur, Missouri, Verenigde Staten, 63141
- Werving
- Siteman Cancer Center at West County Hospital
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Contact:
- Site Public Contact
- Telefoonnummer: 800-600-3606
- E-mail: info@siteman.wustl.edu
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Hoofdonderzoeker:
- Nikolaos Trikalinos
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Kansas City, Missouri, Verenigde Staten, 64108
- Werving
- Children's Mercy Hospitals and Clinics
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Hoofdonderzoeker:
- Keith J. August
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Contact:
- Site Public Contact
- Telefoonnummer: 816-302-6808
- E-mail: COGResearchGroup@cmh.edu
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Springfield, Missouri, Verenigde Staten, 65807
- Werving
- CoxHealth South Hospital
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Hoofdonderzoeker:
- Jay W. Carlson
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Contact:
- Site Public Contact
- Telefoonnummer: 417-269-4520
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St Louis, Missouri, Verenigde Staten, 63110
- Werving
- Washington University School of Medicine
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Contact:
- Site Public Contact
- Telefoonnummer: 800-600-3606
- E-mail: info@siteman.wustl.edu
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Hoofdonderzoeker:
- Nikolaos Trikalinos
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St Louis, Missouri, Verenigde Staten, 63129
- Werving
- Siteman Cancer Center-South County
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Contact:
- Site Public Contact
- Telefoonnummer: 800-600-3606
- E-mail: info@siteman.wustl.edu
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Hoofdonderzoeker:
- Nikolaos Trikalinos
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St Louis, Missouri, Verenigde Staten, 63136
- Werving
- Siteman Cancer Center at Christian Hospital
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Contact:
- Site Public Contact
- Telefoonnummer: 800-600-3606
- E-mail: info@siteman.wustl.edu
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Hoofdonderzoeker:
- Nikolaos Trikalinos
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Nebraska
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Bellevue, Nebraska, Verenigde Staten, 68123
- Werving
- Nebraska Medicine-Bellevue
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Contact:
- Site Public Contact
- Telefoonnummer: 402-559-6941
- E-mail: unmcrsa@unmc.edu
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Hoofdonderzoeker:
- Apar Kishor Ganti
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Omaha, Nebraska, Verenigde Staten, 68198
- Werving
- University of Nebraska Medical Center
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Contact:
- Site Public Contact
- Telefoonnummer: 402-559-6941
- E-mail: unmcrsa@unmc.edu
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Hoofdonderzoeker:
- Apar Kishor Ganti
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Omaha, Nebraska, Verenigde Staten, 68118
- Werving
- Nebraska Medicine-Village Pointe
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Contact:
- Site Public Contact
- Telefoonnummer: 402-559-5600
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Hoofdonderzoeker:
- Apar Kishor Ganti
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New Jersey
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Basking Ridge, New Jersey, Verenigde Staten, 07920
- Werving
- Memorial Sloan Kettering Basking Ridge
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Contact:
- Site Public Contact
- Telefoonnummer: 212-639-7592
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Hoofdonderzoeker:
- Nitya P. Raj
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Middletown, New Jersey, Verenigde Staten, 07748
- Werving
- Memorial Sloan Kettering Monmouth
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Contact:
- Site Public Contact
- Telefoonnummer: 212-639-7592
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Hoofdonderzoeker:
- Nitya P. Raj
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Montvale, New Jersey, Verenigde Staten, 07645
- Werving
- Memorial Sloan Kettering Bergen
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Contact:
- Site Public Contact
- Telefoonnummer: 212-639-7592
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Hoofdonderzoeker:
- Nitya P. Raj
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New York
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Commack, New York, Verenigde Staten, 11725
- Werving
- Memorial Sloan Kettering Commack
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Contact:
- Site Public Contact
- Telefoonnummer: 212-639-7592
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Hoofdonderzoeker:
- Nitya P. Raj
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Harrison, New York, Verenigde Staten, 10604
- Werving
- Memorial Sloan Kettering Westchester
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Contact:
- Site Public Contact
- Telefoonnummer: 212-639-7592
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Hoofdonderzoeker:
- Nitya P. Raj
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New York, New York, Verenigde Staten, 10065
- Werving
- Memorial Sloan Kettering Cancer Center
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Contact:
- Site Public Contact
- Telefoonnummer: 212-639-7592
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Hoofdonderzoeker:
- Nitya P. Raj
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Uniondale, New York, Verenigde Staten, 11553
- Werving
- Memorial Sloan Kettering Nassau
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Contact:
- Site Public Contact
- Telefoonnummer: 212-639-7592
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Hoofdonderzoeker:
- Nitya P. Raj
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North Carolina
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Cary, North Carolina, Verenigde Staten, 27518
- Geschorst
- Duke Cancer Center Cary
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Durham, North Carolina, Verenigde Staten, 27710
- Werving
- Duke University Medical Center
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Contact:
- Site Public Contact
- Telefoonnummer: 888-275-3853
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Hoofdonderzoeker:
- Diane L. Reidy-lagunes
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Raleigh, North Carolina, Verenigde Staten, 27609
- Werving
- Duke Cancer Center Raleigh
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Contact:
- Site Public Contact
- E-mail: NCTNStudyTeam@dm.duke.edu
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Hoofdonderzoeker:
- Diane L. Reidy-lagunes
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Ohio
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Columbus, Ohio, Verenigde Staten, 43210
- Werving
- Ohio State University Comprehensive Cancer Center
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Contact:
- Site Public Contact
- Telefoonnummer: 800-293-5066
- E-mail: Jamesline@osumc.edu
-
Hoofdonderzoeker:
- Bhavana Konda
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- Werving
- University of Oklahoma Health Sciences Center
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Contact:
- Site Public Contact
- Telefoonnummer: 405-271-8777
- E-mail: ou-clinical-trials@ouhsc.edu
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Hoofdonderzoeker:
- Adanma Anji Ayanambakkam Attanathi
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15224
- Werving
- Children's Hospital of Pittsburgh of UPMC
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Contact:
- Site Public Contact
- Telefoonnummer: 412-692-8570
- E-mail: jean.tersak@chp.edu
-
Hoofdonderzoeker:
- Brittani K. Seynnaeve
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South Carolina
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Boiling Springs, South Carolina, Verenigde Staten, 29316
- Werving
- Prisma Health Cancer Institute - Spartanburg
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Hoofdonderzoeker:
- Aniket Saha
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Contact:
- Site Public Contact
- Telefoonnummer: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Columbia, South Carolina, Verenigde Staten, 29203
- Werving
- Prisma Health Richland Hospital
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Hoofdonderzoeker:
- Aniket Saha
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Contact:
- Site Public Contact
- Telefoonnummer: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Easley, South Carolina, Verenigde Staten, 29640
- Werving
- Prisma Health Cancer Institute - Easley
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Hoofdonderzoeker:
- Aniket Saha
-
Contact:
- Site Public Contact
- Telefoonnummer: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Greenville, South Carolina, Verenigde Staten, 29605
- Werving
- BI-LO Charities Children's Cancer Center
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Hoofdonderzoeker:
- Aniket Saha
-
Contact:
- Site Public Contact
- Telefoonnummer: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Greenville, South Carolina, Verenigde Staten, 29605
- Werving
- Prisma Health Cancer Institute - Faris
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Hoofdonderzoeker:
- Aniket Saha
-
Contact:
- Site Public Contact
- Telefoonnummer: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
-
Greenville, South Carolina, Verenigde Staten, 29605
- Werving
- Prisma Health Cancer Institute - Butternut
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Hoofdonderzoeker:
- Aniket Saha
-
Contact:
- Site Public Contact
- Telefoonnummer: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Greenville, South Carolina, Verenigde Staten, 29615
- Werving
- Prisma Health Cancer Institute - Eastside
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Hoofdonderzoeker:
- Aniket Saha
-
Contact:
- Site Public Contact
- Telefoonnummer: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Greer, South Carolina, Verenigde Staten, 29650
- Werving
- Prisma Health Cancer Institute - Greer
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Hoofdonderzoeker:
- Aniket Saha
-
Contact:
- Site Public Contact
- Telefoonnummer: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Seneca, South Carolina, Verenigde Staten, 29672
- Werving
- Prisma Health Cancer Institute - Seneca
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Hoofdonderzoeker:
- Aniket Saha
-
Contact:
- Site Public Contact
- Telefoonnummer: 864-522-4317
- E-mail: Kim.Williams3@prismahealth.org
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Tennessee
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Memphis, Tennessee, Verenigde Staten, 38105
- Werving
- Saint Jude Children's Research Hospital
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Contact:
- Site Public Contact
- Telefoonnummer: 888-226-4343
- E-mail: referralinfo@stjude.org
-
Hoofdonderzoeker:
- Catherine G. Lam
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Texas
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Austin, Texas, Verenigde Staten, 78723
- Werving
- Dell Children's Medical Center of Central Texas
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Contact:
- Site Public Contact
- Telefoonnummer: 512-628-1902
- E-mail: TXAUS-DL-SFCHemonc.research@ascension.org
-
Hoofdonderzoeker:
- Shannon M. Cohn
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Dallas, Texas, Verenigde Staten, 75390
- Werving
- UT Southwestern/Simmons Cancer Center-Dallas
-
Contact:
- Site Public Contact
- Telefoonnummer: 214-648-7097
- E-mail: canceranswerline@UTSouthwestern.edu
-
Hoofdonderzoeker:
- Suzanne M. Cole
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Dallas, Texas, Verenigde Staten, 75235
- Werving
- Parkland Memorial Hospital
-
Contact:
- Site Public Contact
- Telefoonnummer: 214-590-5582
- E-mail: canceranswerline@UTSouthwestern.edu
-
Hoofdonderzoeker:
- Suzanne M. Cole
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Dallas, Texas, Verenigde Staten, 75237
- Werving
- UT Southwestern Simmons Cancer Center - RedBird
-
Hoofdonderzoeker:
- Suzanne M. Cole
-
Contact:
- Site Public Contact
- Telefoonnummer: 214-648-7097
- E-mail: canceranswerline@utsouthwestern.edu
-
Fort Worth, Texas, Verenigde Staten, 76104
- Werving
- Cook Children's Medical Center
-
Contact:
- Site Public Contact
- Telefoonnummer: 682-885-2103
- E-mail: CookChildrensResearch@cookchildrens.org
-
Hoofdonderzoeker:
- Kelly L. Vallance
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Fort Worth, Texas, Verenigde Staten, 76104
- Werving
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Contact:
- Site Public Contact
- Telefoonnummer: 214-648-7097
- E-mail: canceranswerline@UTSouthwestern.edu
-
Hoofdonderzoeker:
- Suzanne M. Cole
-
Richardson, Texas, Verenigde Staten, 75080
- Werving
- UT Southwestern Clinical Center at Richardson/Plano
-
Contact:
- Site Public Contact
- Telefoonnummer: 972-669-7044
- E-mail: Suzanne.cole@utsouthwestern.edu
-
Hoofdonderzoeker:
- Suzanne M. Cole
-
San Antonio, Texas, Verenigde Staten, 78207
- Werving
- Children's Hospital of San Antonio
-
Contact:
- Site Public Contact
- Telefoonnummer: 210-704-2894
- E-mail: bridget.medina@christushealth.org
-
Hoofdonderzoeker:
- Julie Voeller
-
San Antonio, Texas, Verenigde Staten, 78229
- Werving
- University of Texas Health Science Center at San Antonio
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Contact:
- Site Public Contact
- Telefoonnummer: 210-450-3800
- E-mail: phoresearchoffice@uthscsa.edu
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Hoofdonderzoeker:
- Aaron J. Sugalski
-
-
Virginia
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Richmond, Virginia, Verenigde Staten, 23235
- Werving
- VCU Massey Cancer Center at Stony Point
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Contact:
- Site Public Contact
- E-mail: ctoclinops@vcu.edu
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Hoofdonderzoeker:
- Asit K. Paul
-
Richmond, Virginia, Verenigde Staten, 23298
- Werving
- VCU Massey Comprehensive Cancer Center
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Hoofdonderzoeker:
- Asit K. Paul
-
Contact:
- Site Public Contact
- Telefoonnummer: 804-628-6430
- E-mail: CTOclinops@vcu.edu
-
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Washington
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Seattle, Washington, Verenigde Staten, 98195
- Werving
- University of Washington Medical Center - Montlake
-
Contact:
- Site Public Contact
- Telefoonnummer: 800-804-8824
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Hoofdonderzoeker:
- Keith D. Eaton
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Seattle, Washington, Verenigde Staten, 98109
- Werving
- Fred Hutchinson Cancer Center
-
Contact:
- Site Public Contact
- Telefoonnummer: 800-804-8824
-
Hoofdonderzoeker:
- Keith D. Eaton
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
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STEP 1: No history of pneumonitis
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STEP 1: No known tumor invading or encasing any major blood vessels
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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
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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
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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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
Andere namen:
Undergo MRI
Andere namen:
Undergo CT scan
Andere namen:
Given PO |
|
Experimenteel: 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
Andere namen:
Undergo MRI
Andere namen:
Undergo CT scan
Andere namen:
Given PO Given IV
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Progression free survival (PFS)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence of adverse events
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Median PFS for patients who cross over
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Bhavana Konda, Alliance for Clinical Trials in Oncology
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Endocriene systeemziekten
- Neoplasmata per site
- Neoplasmata
- Neoplasmata per histologisch type
- Endocriene klierneoplasmata
- Neoplasmata, glandulair en epitheel
- Adenocarcinoom
- Carcinoom
- Bijnierschors neoplasmata
- Bijnierneoplasmata
- Bijnierschorsziekten
- Bijnierziekten
- Bijnierschorscarcinoom
- Onderzoekstechnieken
- Klinische laboratoriumtechnieken
- Diagnostische technieken en procedures
- Diagnose
- Chemie -technieken, analytisch
- Spectrumanalyse
- Exemplaarbehandeling
- Magnetische resonantiespectroscopie
- cabozantinib
- cemiplimab
Andere studie-ID-nummers
- NCI-2025-02021
- U10CA180821 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2025-02021 (Register-ID: CTRP (Clinical Trial Reporting Program))
- A092204 (Andere identificatie: CTEP)
- A092204 (Andere identificatie: Alliance for Clinical Trials in Oncology)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Informatie over medicijnen en apparaten, studiedocumenten
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product vervaardigd in en geëxporteerd uit de V.S.
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