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CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma (CANTATA)

Primary Purpose

Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CB-839
Cabozantinib
Placebo
Sponsored by
Calithera Biosciences, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Renal Cell Carcinoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 RECIST 1.1
  5. 1-2 lines of prior therapy for advanced or metastatic RCC including one anti-angiogenic therapy (any 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 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 HIV, Hepatitis B or C virus
  6. Inability to discontinue proton-pump-inhibitor use before randomization
  7. Patients who are pregnant or lactating

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic Cancer Center
  • The University of Arizona Cancer Center
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
  • Stanford Cancer Center
  • Salinas Valley Memorial Healthcare System
  • St. Joseph Heritage Healthcare
  • Penrose Cancer Center, Research Department
  • Georgetown University Medical Center
  • Florida Cancer Specialists
  • University of Miami Sylvester Comprehensive Cancer Center
  • Florida Cancer Specialists
  • H.Lee Moffitt Cancer & Research Institute (Moffitt Cancer Center)
  • Emory Winship Cancer Institute
  • Georgia Cancer Center at Augusta University
  • Northwest Georgia Oncology Centers, PC
  • St. Luke's Mountain States Tumor Institute
  • Northwestern University
  • University of Chicago
  • NorthShore University HealthSystem
  • AMITA Health Cancer Institute & Outpatient Center
  • Orchard Healthcare Research, Inc.
  • Northwestern Medicine Cancer Center Warrenville
  • Goshen Center for Cancer Care
  • East Jefferson General Hospital
  • Ochsner Clinic Foundation
  • University of Maryland, Greenebaum Comprehensive Cancer Center
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Karmanos Cancer Institute
  • HealthPartners Institute, Regions Cancer Care Center
  • Hattiesburg Clinic Hematology/Oncology
  • University of Mississippi Medical Center
  • Mercy Hospital
  • HCA Midwest Health
  • Comprehensive Cancer Centers of Nevada
  • San Juan Oncology Associates, PC
  • Roswell Park Cancer Center
  • North Shore Hematology Oncology Associates PC dba NY Cancer and Blood Specialists
  • NYU Winthrop Hospital
  • Northern Westchester Hospital
  • Stony Brook Cancer Center
  • Levine Cancer Institute
  • Duke University Medical Center
  • INTEGRIS Cancer Institute of Oklahoma Proton Campus
  • Fox Chase Cancer Center
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
  • Medical University of South Carolina
  • Saint Francis Hospital Cancer Center
  • West Cancer Center
  • The Sarah Cannon Research Institute
  • Vanderbilt University Medical Center
  • The Center for Cancer and Blood Disorders
  • The University of Texas MD Anderson Cancer Center
  • University of Utah, Huntsman Cancer Institute
  • Kadlec Clinic Hematology and Oncology
  • Froedtert Hospital and the Medical College of Wisconsin
  • Southern Highlands Private Hospital (Cancer Centre)
  • Chris O'Brien Lifehouse
  • MacQuarie University Hospital
  • Liverpool Hospital
  • Tweed Hospital
  • Pindara Private Hospital
  • Cairns Hospital
  • Mater Misericordiae Limited - Division of Cancer Services
  • Princess Alexandra Hospital
  • Ballarat Health Services
  • Peninsula Private Hospital
  • Cabrini Hospital
  • Goulburn Valley Health
  • Hollywood Private Hospital
  • Centre hospitalier régional universitaire (CHRU) de Besançon - Jean-Minjoz
  • CHU de Bordeaux Hôpital Saint André
  • Centre François Baclesse
  • Centre Jean Perrin
  • Centre hospitalier universitaire (CHU) Henri-Mondor
  • Centre Georges-François Leclerc
  • Centre Léon Bérard
  • Institut Paoli-Calmettes Service d'Urologie
  • Institut de Cancérologie de Montpellier (ICM)
  • Centre Antoine Lacassagne
  • Hôpital Européen Georges-Pompidou (HEGP)
  • Institut de Cancérologie de l'Ouest (ICO) - Centre René Gauducheau
  • CHU de Strasbourg (Les Hôpitaux Universitaires de Strasbourg)
  • IUCTO Bureau des Essais Cliniques (Institut Claudius Regaud)
  • Institut de Cancérologie de Lorraine
  • Institut Gustave Roussy - Le département de Medecine oncologique
  • Medical University Heidelberg, NCT (National Center for Tumour Diseases), Medical Oncology
  • Technischen Universitat München - Urologische Klinik
  • Charité Universitätsmedizin Berlin, Dept. of Interdisciplinary Urology
  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik
  • Universitätsklinikum Essen (AöR) Westdeutsches Tumorzentrum
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Tübingen, Klinik für Urologie
  • Presidio Ospedaliero Antonio Perrino - U.O.C. Oncologia Medica
  • S.C. Oncologia - ASST Cremona P.O. Ospedale di Cremona
  • U.O.C. ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Istituto Europeo di Oncologia - Divisione di Oncologia Medica Urogenitale e Cervico Facciale
  • University of Modena and Reggio Emilia (Azienda Ospedaliera-Universitaria Policlinico Modena)
  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
  • Azienda Ospedaliero Universitaria San Luigi Gonzaga
  • Unità Operativa (UO) di Oncologia Medica - ICS Maugeri
  • U.O. Oncologia Ospedale degli Infermi - Dipartimento di Oncologia ed Ematologia
  • Policlinico Universitario A. Gemelli
  • Policlinico Universitario Campus Bio-Medico
  • Auckland City Hospital
  • Christchurch Hospital
  • Waikato Hospital
  • Wellington Regional Hospital
  • Hospital Universitario Virgen del Rocío
  • Hospital Universitari VHIO - Vall d'Hebron Departamento de Oncologia
  • El Hospital Clínic i Provincial de Barcelona (HCPB)
  • Hospital de la Santa Creu i Sant Pau
  • Institut Català d'Oncologia (ICO) L'Hospitalet
  • Institut Català d'Oncologia
  • HGU Gregorio Marañon
  • MD Anderson Cancer Center Madrid
  • El Hospital Universitario 12 de Octubre
  • Centro Integral Oncologico Clara Campal (CIOCC) HM
  • Hospital Parc Taulí de Sabadell
  • Hospital Universitario Virgen de Macarena
  • Fundación Instituto Valencia d'Oncología (IVO)
  • The Christie NHS Foundation Trust
  • Beatson West of Scotland Cancer Centre
  • Mount Vernon Cancer Centre
  • Nottingham University Hospitals NHS Trust - City Hospital Campus
  • St. Bartholomew's Hospital, Barts Health NHS Trust
  • The Royal Marsden NHS Foundation Trust
  • Sarah Cannon Research Institute UK Limited
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Pbo-Cabo

CB-Cabo

Arm Description

Placebo twice daily (BID) + cabozantinib (60 mg once daily [QD]) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or unacceptable toxicity, whichever occurred first.

CB-839 800 mg BID + cabozantinib (60 mg QD) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per RECIST v1.1 or unacceptable toxicity, whichever occurred first.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) as Assessed by the Independent Radiology Committee (IRC)
PFS is defined as the time from randomization to the occurrence of disease progression as assessed by the IRC using RECIST v1.1 or death from any cause, whichever occurs first. Subjects not experiencing disease progression or death at the time of analysis of PFS will be censored at the date of the last evaluable radiographic disease assessment. RECIST v1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause. Estimated from Kaplan-Meier methodology. 95% confidence interval (CI) based on Brookmeyer-Crowley methodology.
PFS as Assessed by the Investigator
PFS is defined as the time from randomization to the occurrence of disease progression as assessed by the IRC using RECIST v1.1 or death from any cause, whichever occurs first. Subjects not experiencing disease progression or death at the time of analysis of PFS will be censored at the date of the last evaluable radiographic disease assessment. RECIST v1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Full Information

First Posted
February 5, 2018
Last Updated
February 21, 2023
Sponsor
Calithera Biosciences, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03428217
Brief Title
CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
Acronym
CANTATA
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
July 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calithera Biosciences, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants, care providers, investigators and outcomes assessors are blinded to treatment. Progression free survival (PFS) will be assessed by a blinded Independent Radiology Committee for the primary endpoint of the study.
Allocation
Randomized
Enrollment
444 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pbo-Cabo
Arm Type
Placebo Comparator
Arm Description
Placebo twice daily (BID) + cabozantinib (60 mg once daily [QD]) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or unacceptable toxicity, whichever occurred first.
Arm Title
CB-Cabo
Arm Type
Experimental
Arm Description
CB-839 800 mg BID + cabozantinib (60 mg QD) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per RECIST v1.1 or unacceptable toxicity, whichever occurred first.
Intervention Type
Drug
Intervention Name(s)
CB-839
Other Intervention Name(s)
telaglenastat
Intervention Description
Oral glutaminase inhibitor
Intervention Type
Drug
Intervention Name(s)
Cabozantinib
Other Intervention Name(s)
Cabometyx, Cabometriq
Intervention Description
Oral receptor tyrosine kinase inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) as Assessed by the Independent Radiology Committee (IRC)
Description
PFS is defined as the time from randomization to the occurrence of disease progression as assessed by the IRC using RECIST v1.1 or death from any cause, whichever occurs first. Subjects not experiencing disease progression or death at the time of analysis of PFS will be censored at the date of the last evaluable radiographic disease assessment. RECIST v1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame
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 Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause. Estimated from Kaplan-Meier methodology. 95% confidence interval (CI) based on Brookmeyer-Crowley methodology.
Time Frame
Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for OS was 25.86 months.
Title
PFS as Assessed by the Investigator
Description
PFS is defined as the time from randomization to the occurrence of disease progression as assessed by the IRC using RECIST v1.1 or death from any cause, whichever occurs first. Subjects not experiencing disease progression or death at the time of analysis of PFS will be censored at the date of the last evaluable radiographic disease assessment. RECIST v1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame
Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for PFS was 22.64 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component Adult patients Karnofsky Performance Score (KPS) ≥ 70% Measurable Disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) 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 Adequate hepatic, renal, cardiac and hematologic function Exclusion Criteria: Prior treatment with cabozantinib (or other mesenchymal-epithelial transition [MET] inhibitor) or CB-839 Receipt of other anticancer therapy within 2-6 weeks, depending on the treatment Untreated or active brain metastases or central nervous system cancer, as defined per protocol Prior gastric surgery, small bowel resection, or other conditions that may impede adequate absorption of oral study drug Known active infection with human immunodeficiency virus (HIV), Hepatitis B or C virus Inability to discontinue proton-pump-inhibitor use before randomization Patients who are pregnant or lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Whiting, M.D., Ph.D.
Organizational Affiliation
Calithera Biosciences, Inc
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
The University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Salinas Valley Memorial Healthcare System
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Penrose Cancer Center, Research Department
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
H.Lee Moffitt Cancer & Research Institute (Moffitt Cancer Center)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Georgia Cancer Center at Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwest Georgia Oncology Centers, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
St. Luke's Mountain States Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
AMITA Health Cancer Institute & Outpatient Center
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Orchard Healthcare Research, Inc.
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Northwestern Medicine Cancer Center Warrenville
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
Goshen Center for Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
East Jefferson General Hospital
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland, Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
HealthPartners Institute, Regions Cancer Care Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Hattiesburg Clinic Hematology/Oncology
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Mercy Hospital
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
HCA Midwest Health
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
San Juan Oncology Associates, PC
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
Roswell Park Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
North Shore Hematology Oncology Associates PC dba NY Cancer and Blood Specialists
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
NYU Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Northern Westchester Hospital
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Stony Brook Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
INTEGRIS Cancer Institute of Oklahoma Proton Campus
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73142
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Saint Francis Hospital Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah, Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Froedtert Hospital and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Southern Highlands Private Hospital (Cancer Centre)
City
Bowral
State/Province
New South Wales
ZIP/Postal Code
2576
Country
Australia
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
MacQuarie University Hospital
City
North Ryde
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Liverpool Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Tweed Hospital
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
Pindara Private Hospital
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Cairns Hospital
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Mater Misericordiae Limited - Division of Cancer Services
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Ballarat Health Services
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Peninsula Private Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Cabrini Hospital
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Goulburn Valley Health
City
Shepparton
State/Province
Victoria
ZIP/Postal Code
3630
Country
Australia
Facility Name
Hollywood Private Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Centre hospitalier régional universitaire (CHRU) de Besançon - Jean-Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU de Bordeaux Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre François Baclesse
City
Caen Cedex 5
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre hospitalier universitaire (CHU) Henri-Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Georges-François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Paoli-Calmettes Service d'Urologie
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Institut de Cancérologie de Montpellier (ICM)
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189 Nice Cedex 2
Country
France
Facility Name
Hôpital Européen Georges-Pompidou (HEGP)
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Institut de Cancérologie de l'Ouest (ICO) - Centre René Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
CHU de Strasbourg (Les Hôpitaux Universitaires de Strasbourg)
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
IUCTO Bureau des Essais Cliniques (Institut Claudius Regaud)
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
CS 30519 54519
Country
France
Facility Name
Institut Gustave Roussy - Le département de Medecine oncologique
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Medical University Heidelberg, NCT (National Center for Tumour Diseases), Medical Oncology
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Technischen Universitat München - Urologische Klinik
City
München
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin, Dept. of Interdisciplinary Urology
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Essen (AöR) Westdeutsches Tumorzentrum
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Tübingen, Klinik für Urologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Presidio Ospedaliero Antonio Perrino - U.O.C. Oncologia Medica
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Facility Name
S.C. Oncologia - ASST Cremona P.O. Ospedale di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
U.O.C. ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo
City
Milano
ZIP/Postal Code
20153
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Europeo di Oncologia - Divisione di Oncologia Medica Urogenitale e Cervico Facciale
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
University of Modena and Reggio Emilia (Azienda Ospedaliera-Universitaria Policlinico Modena)
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Unità Operativa (UO) di Oncologia Medica - ICS Maugeri
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
U.O. Oncologia Ospedale degli Infermi - Dipartimento di Oncologia ed Ematologia
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
Policlinico Universitario A. Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-Medico
City
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Name
Auckland City Hospital
City
Auckland
State/Province
Grafton
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
State/Province
South Island
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Wellington Regional Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Hospital Universitario Virgen del Rocío
City
Seville
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari VHIO - Vall d'Hebron Departamento de Oncologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
El Hospital Clínic i Provincial de Barcelona (HCPB)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Institut Català d'Oncologia (ICO) L'Hospitalet
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Institut Català d'Oncologia
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
HGU Gregorio Marañon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
MD Anderson Cancer Center Madrid
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
El Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal (CIOCC) HM
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Parc Taulí de Sabadell
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario Virgen de Macarena
City
Seville
ZIP/Postal Code
41009
Country
Spain
Facility Name
Fundación Instituto Valencia d'Oncología (IVO)
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
The Christie NHS Foundation Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
London
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust - City Hospital Campus
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
St. Bartholomew's Hospital, Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A7BE
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute UK Limited
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36048457
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.
Results Reference
derived

Learn more about this trial

CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma

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