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

February 21, 2023 updated by: Calithera Biosciences, Inc

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) in combination with cabozantinib versus placebo with cabozantinib in Renal Cell Carcinoma patients with at least one and not more than 2 prior therapies in the advanced or metastatic setting.

Study Type

Interventional

Enrollment (Actual)

444

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Bowral, New South Wales, Australia, 2576
        • Southern Highlands Private Hospital (Cancer Centre)
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • North Ryde, New South Wales, Australia, 2109
        • Macquarie University Hospital
      • Sydney, New South Wales, Australia, 2170
        • Liverpool Hospital
      • Tweed Heads, New South Wales, Australia, 2485
        • Tweed Hospital
    • Queensland
      • Benowa, Queensland, Australia, 4217
        • Pindara Private Hospital
      • Cairns, Queensland, Australia, 4870
        • Cairns Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Limited - Division of Cancer Services
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Ballarat Health Services
      • Frankston, Victoria, Australia, 3199
        • Peninsula Private Hospital
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital
      • Shepparton, Victoria, Australia, 3630
        • Goulburn Valley Health
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Hollywood Private Hospital
  • France
      • Besançon, France, 25030
        • Centre hospitalier régional universitaire (CHRU) de Besançon - Jean-Minjoz
      • Bordeaux, France, 33000
        • CHU de Bordeaux Hôpital Saint André
      • Caen Cedex 5, France, 14076
        • Centre Francois Baclesse
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin
      • Créteil, France, 94010
        • Centre hospitalier universitaire (CHU) Henri-Mondor
      • Dijon, France, 21079
        • Centre Georges-Francois Leclerc
      • Lyon, France, 69008
        • Centre Leon Berard
      • Marseille, France, 13009
        • Institut Paoli-Calmettes Service d'Urologie
      • Montpellier, France, 34298
        • Institut de Cancérologie de Montpellier (ICM)
      • Nice, France, 06189 Nice Cedex 2
        • Centre Antoine Lacassagne
      • Paris, France, 75015
        • Hopital Europeen Georges-Pompidou (HEGP)
      • Saint-Herblain, France, 44805
        • Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau
      • Strasbourg, France, 67091
        • CHU de Strasbourg (Les Hôpitaux Universitaires de Strasbourg)
      • Toulouse, France, 31059
        • IUCTO Bureau des Essais Cliniques (Institut Claudius Regaud)
      • Vandœuvre-lès-Nancy, France, CS 30519 54519
        • Institut de Cancerologie de Lorraine
      • Villejuif Cedex, France, 94805
        • Institut Gustave Roussy - Le département de Medecine oncologique
  • Germany
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Berlin, Dept. of Interdisciplinary Urology
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik
      • Essen, Germany, 45147
        • Universitätsklinikum Essen (AöR) Westdeutsches Tumorzentrum
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Tübingen, Germany, 72076
        • Universitatsklinikum Tubingen, Klinik fur Urologie
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • Medical University Heidelberg, NCT (National Center for Tumour Diseases), Medical Oncology
    • Bavaria
      • München, Bavaria, Germany, 81675
        • Technischen Universitat München - Urologische Klinik
  • Italy
      • Brindisi, Italy, 72100
        • Presidio Ospedaliero Antonio Perrino - U.O.C. Oncologia Medica
      • Cremona, Italy, 26100
        • S.C. Oncologia - ASST Cremona P.O. Ospedale di Cremona
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia - Divisione di Oncologia Medica Urogenitale e Cervico Facciale
      • Milano, Italy, 20153
        • U.O.C. ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo
      • Modena, Italy, 41124
        • University of Modena and Reggio Emilia (Azienda Ospedaliera-Universitaria Policlinico Modena)
      • Naples, Italy, 80131
        • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
      • Orbassano, Italy, 10043
        • Azienda Ospedaliero Universitaria San Luigi Gonzaga
      • Pavia, Italy, 27100
        • Unità Operativa (UO) di Oncologia Medica - ICS Maugeri
      • Rimini, Italy, 47923
        • U.O. Oncologia Ospedale degli Infermi - Dipartimento di Oncologia ed Ematologia
      • Roma, Italy, 00168
        • Policlinico Universitario A. Gemelli
      • Rome, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico
  • New Zealand
      • Hamilton, New Zealand, 3240
        • Waikato Hospital
      • Wellington, New Zealand, 6021
        • Wellington Regional Hospital
    • Grafton
      • Auckland, Grafton, New Zealand, 1023
        • Auckland City Hospital
    • South Island
      • Christchurch, South Island, New Zealand, 8011
        • Christchurch Hospital
  • Spain
      • Barcelona, Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08035
        • Hospital Universitari VHIO - Vall d'Hebron Departamento de Oncologia
      • Barcelona, Spain, 08036
        • El Hospital Clínic i Provincial de Barcelona (HCPB)
      • Barcelona, Spain, 08908
        • Institut Català d'Oncología (ICO) L'Hospitalet
      • Girona, Spain, 17007
        • Institut Catala d'Oncologia
      • Madrid, Spain, 28009
        • HGU Gregorio Marañon
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center Madrid
      • Madrid, Spain, 28041
        • El Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal (CIOCC) HM
      • Sabadell, Spain, 08208
        • Hospital Parc Taulí de Sabadell
      • Seville, Spain, 41009
        • Hospital Universitario Virgen de Macarena
      • Valencia, Spain, 46009
        • Fundación Instituto Valencia d'Oncología (IVO)
    • Andalucia
      • Seville, Andalucia, Spain, 41013
        • Hospital Universitario Virgen del Rocio
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust
      • London, United Kingdom, EC1A7BE
        • St. Bartholomew's Hospital, Barts Health NHS Trust
      • London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute UK Limited
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
    • Middlesex
      • London, Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust - City Hospital campus
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Cancer Center
      • Tucson, Arizona, United States, 85724
        • The University of Arizona Cancer Center
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Center
      • Salinas, California, United States, 93901
        • Salinas Valley Memorial Healthcare System
      • Santa Rosa, California, United States, 95403
        • St. Joseph Heritage Healthcare
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Penrose Cancer Center, Research Department
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
      • Tampa, Florida, United States, 33612
        • H.Lee Moffitt Cancer & Research Institute (Moffitt Cancer Center)
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Winship Cancer Institute
      • Augusta, Georgia, United States, 30912
        • Georgia Cancer Center at Augusta University
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, PC
    • Idaho
      • Boise, Idaho, United States, 83712
        • St. Luke's Mountain States Tumor Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem
      • Hinsdale, Illinois, United States, 60521
        • AMITA Health Cancer Institute & Outpatient Center
      • Skokie, Illinois, United States, 60077
        • Orchard Healthcare Research, Inc.
      • Warrenville, Illinois, United States, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Goshen Center for Cancer Care
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • East Jefferson General Hospital
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Greenebaum Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • HealthPartners Institute, Regions Cancer Care Center
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic Hematology/Oncology
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Joplin, Missouri, United States, 64804
        • Mercy Hospital
      • Kansas City, Missouri, United States, 64132
        • HCA Midwest Health
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Comprehensive Cancer Centers of Nevada
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Associates, PC
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Center
      • East Setauket, New York, United States, 11733
        • North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists
      • Mineola, New York, United States, 11501
        • NYU Winthrop Hospital
      • Mount Kisco, New York, United States, 10549
        • Northern Westchester Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73142
        • INTEGRIS Cancer Institute of Oklahoma Proton Campus
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29607
        • Saint Francis Hospital Cancer Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • West Cancer Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Research Institute
    • Texas
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah, Huntsman Cancer Institute
    • Washington
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Hematology and Oncology
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital and the Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Pbo-Cabo
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.
Drug: Placebo
Placebo tablets
Drug: Cabozantinib
Oral receptor tyrosine kinase inhibitor
Other Names:
  • Cabometyx
  • Cabometriq
Experimental: CB-Cabo
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.
Drug: CB-839
Oral glutaminase inhibitor
Other Names:
  • telaglenastat
Drug: Cabozantinib
Oral receptor tyrosine kinase inhibitor
Other Names:
  • Cabometyx
  • Cabometriq

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) as Assessed by the Independent Radiology Committee (IRC)
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.

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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
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.
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.
Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for OS was 25.86 months.
PFS as Assessed by the Investigator
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.

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.
Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for PFS was 22.64 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calithera Biosciences, Inc

Investigators

  • Study Director: Sam Whiting, M.D., Ph.D., Calithera Biosciences, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2018

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

July 16, 2021

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CX-839-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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