Clinical trial NCT03428217: CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Keywords: Tumor Metabolism
RCC
Glutaminase Inhibitor
CB-839
CANTATA
TKI
Tyrosine Kinase Inhibitor
cabozantinib
Cabometyx
Cometriq
glutaminase
glutamine
renal cell
clear cell
kidney cancer
cMET
MET
HGFR
telaglenastat
Lead sponsor: Calithera Biosciences, Inc
Sponsor class: INDUSTRY
First posted: 2018-02-09
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double blinded placebo-controlled study where patients will be randomized 1:1 to either CB-839 (telaglenastat) plus cabozantinib or placebo plus cabozantinib
Primary purpose: TREATMENT

Brief summary: Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC).


Eligibility criteria: Inclusion Criteria:

1. Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
2. Adult patients
3. Karnofsky Performance Score (KPS) ≥ 70%
4. Measurable Disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
5. 1-2 lines of prior therapy for advanced or metastatic renal cell carcinoma (RCC) including one anti-angiogenic therapy (any vascular endothelial growth factor \[VEGF\] pathway-targeted agent used either as monotherapy or as a component of a combination regimen) OR the combination regimen of nivolumab + ipilimumab
6. Adequate hepatic, renal, cardiac and hematologic function

Exclusion Criteria:

1. Prior treatment with cabozantinib (or other mesenchymal-epithelial transition \[MET\] inhibitor) or CB-839
2. Receipt of other anticancer therapy within 2-6 weeks, depending on the treatment
3. Untreated or active brain metastases or central nervous system cancer, as defined per protocol
4. Prior gastric surgery, small bowel resection, or other conditions that may impede adequate absorption of oral study drug
5. Known active infection with human immunodeficiency virus (HIV), Hepatitis B or C virus
6. Inability to discontinue proton-pump-inhibitor use before randomization
7. Patients who are pregnant or lactating

Primary outcomes:
measure: Progression-Free Survival (PFS) as Assessed by the Independent Radiology Committee (IRC)
timeFrame: Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for PFS was 22.14 months.
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for OS was 25.86 months.
measure: PFS as Assessed by the Investigator
timeFrame: Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for PFS was 22.64 months.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Cancer Center
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Center
state: California
city: Salinas
country: United States
facility: Salinas Valley Memorial Healthcare System
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Colorado Springs
country: United States
facility: Penrose Cancer Center, Research Department
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: H.Lee Moffitt Cancer & Research Institute (Moffitt Cancer Center)
state: Florida
city: Atlanta
country: United States
facility: Emory Winship Cancer Institute
state: Georgia
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PC
state: Georgia
city: Boise
country: United States
facility: St. Luke's Mountain States Tumor Institute
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Hinsdale
country: United States
facility: AMITA Health Cancer Institute & Outpatient Center
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research, Inc.
state: Illinois
city: Warrenville
country: United States
facility: Northwestern Medicine Cancer Center Warrenville
state: Illinois
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Metairie
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland, Greenebaum Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Paul
country: United States
facility: HealthPartners Institute, Regions Cancer Care Center
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Joplin
country: United States
facility: Mercy Hospital
state: Missouri
city: Kansas City
country: United States
facility: HCA Midwest Health
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Farmington
country: United States
facility: San Juan Oncology Associates, PC
state: New Mexico
city: Buffalo
country: United States
facility: Roswell Park Cancer Center
state: New York
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates PC dba NY Cancer and Blood Specialists
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
city: Mount Kisco
country: United States
facility: Northern Westchester Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: INTEGRIS Cancer Institute of Oklahoma Proton Campus
state: Oklahoma
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Saint Francis Hospital Cancer Center
state: South Carolina
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: The Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Huntsman Cancer Institute
state: Utah
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
city: Bowral
country: Australia
facility: Southern Highlands Private Hospital (Cancer Centre)
state: New South Wales
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: North Ryde
country: Australia
facility: MacQuarie University Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Tweed Heads
country: Australia
facility: Tweed Hospital
state: New South Wales
city: Benowa
country: Australia
facility: Pindara Private Hospital
state: Queensland
city: Cairns
country: Australia
facility: Cairns Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae Limited - Division of Cancer Services
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Ballarat
country: Australia
facility: Ballarat Health Services
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Private Hospital
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Shepparton
country: Australia
facility: Goulburn Valley Health
state: Victoria
city: Nedlands
country: Australia
facility: Hollywood Private Hospital
state: Western Australia
city: Besançon
country: France
facility: Centre hospitalier régional universitaire (CHRU) de Besançon - Jean-Minjoz
city: Bordeaux
country: France
facility: CHU de Bordeaux Hôpital Saint André
city: Caen Cedex 5
country: France
facility: Centre François Baclesse
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Créteil
country: France
facility: Centre hospitalier universitaire (CHU) Henri-Mondor
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli-Calmettes Service d'Urologie
city: Montpellier
country: France
facility: Institut de Cancérologie de Montpellier (ICM)
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou (HEGP)
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest (ICO) - Centre René Gauducheau
city: Strasbourg
country: France
facility: CHU de Strasbourg (Les Hôpitaux Universitaires de Strasbourg)
city: Toulouse
country: France
facility: IUCTO Bureau des Essais Cliniques (Institut Claudius Regaud)
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy - Le département de Medecine oncologique
city: Heidelberg
country: Germany
facility: Medical University Heidelberg, NCT (National Center for Tumour Diseases), Medical Oncology
state: Baden-Wuerttemberg
city: München
country: Germany
facility: Technischen Universitat München - Urologische Klinik
state: Bavaria
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin, Dept. of Interdisciplinary Urology
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik
city: Essen
country: Germany
facility: Universitätsklinikum Essen (AöR) Westdeutsches Tumorzentrum
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Klinik für Urologie
city: Brindisi
country: Italy
facility: Presidio Ospedaliero Antonio Perrino - U.O.C. Oncologia Medica
city: Cremona
country: Italy
facility: S.C. Oncologia - ASST Cremona P.O. Ospedale di Cremona
city: Milano
country: Italy
facility: U.O.C. ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia - Divisione di Oncologia Medica Urogenitale e Cervico Facciale
city: Modena
country: Italy
facility: University of Modena and Reggio Emilia (Azienda Ospedaliera-Universitaria Policlinico Modena)
city: Naples
country: Italy
facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
city: Orbassano
country: Italy
facility: Azienda Ospedaliero Universitaria San Luigi Gonzaga
city: Pavia
country: Italy
facility: Unità Operativa (UO) di Oncologia Medica - ICS Maugeri
city: Rimini
country: Italy
facility: U.O. Oncologia Ospedale degli Infermi - Dipartimento di Oncologia ed Ematologia
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli
city: Rome
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Auckland
country: New Zealand
facility: Auckland City Hospital
state: Grafton
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
state: South Island
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Wellington
country: New Zealand
facility: Wellington Regional Hospital
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocío
state: Andalucia
city: Barcelona
country: Spain
facility: Hospital Universitari VHIO - Vall d'Hebron Departamento de Oncologia
city: Barcelona
country: Spain
facility: El Hospital Clínic i Provincial de Barcelona (HCPB)
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Institut Català d'Oncologia (ICO) L'Hospitalet
city: Girona
country: Spain
facility: Institut Català d'Oncologia
city: Madrid
country: Spain
facility: HGU Gregorio Marañon
city: Madrid
country: Spain
facility: MD Anderson Cancer Center Madrid
city: Madrid
country: Spain
facility: El Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal (CIOCC) HM
city: Sabadell
country: Spain
facility: Hospital Parc Taulí de Sabadell
city: Seville
country: Spain
facility: Hospital Universitario Virgen de Macarena
city: Valencia
country: Spain
facility: Fundación Instituto Valencia d'Oncología (IVO)
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Greater Manchester
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
state: Lanarkshire
city: London
country: United Kingdom
facility: Mount Vernon Cancer Centre
state: Middlesex
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - City Hospital Campus
state: Nottinghamshire
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital, Barts Health NHS Trust
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK Limited
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Calithera Biosciences, Inc
name: Sam Whiting, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: Tannir NM, Agarwal N, Porta C, Lawrence NJ, Motzer R, McGregor B, Lee RJ, Jain RK, Davis N, Appleman LJ, Goodman O Jr, Stadler WM, Gandhi S, Geynisman DM, Iacovelli R, Mellado B, Sepulveda Sanchez JM, Figlin R, Powles T, Akella L, Orford K, Escudier B. Efficacy and Safety of Telaglenastat Plus Cabozantinib vs Placebo Plus Cabozantinib in Patients With Advanced Renal Cell Carcinoma: The CANTATA Randomized Clinical Trial. JAMA Oncol. 2022 Oct 1;8(10):1411-1418. doi: 10.1001/jamaoncol.2022.3511.