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Advanced Renal Cell CarcinomaPhase 2CANTATANCT03428217

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

A Phase 2 study testing CB-839 and Cabozantinib in people with Advanced Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by Calithera Biosciences, Inc at 133 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CB-839 and Cabozantinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
444 participants
Where
133 sitesin 8 countries
Study dates
24 Apr 2018to 16 Jul 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

133 sites in 8 countries.

133 sites in 8 countries

United States59 sites

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

  • University of Maryland, Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • St. Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Center

    Buffalo, New York, 14263

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • Penrose Cancer Center, Research Department

    Colorado Springs, Colorado, 80907

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • North Shore Hematology Oncology Associates PC dba NY Cancer and Blood Specialists

    East Setauket, New York, 11733

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • San Juan Oncology Associates, PC

    Farmington, New Mexico, 87401

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • West Cancer Center

    Germantown, Tennessee, 38138

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Saint Francis Hospital Cancer Center

    Greenville, South Carolina, 29607

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi, 39401

  • AMITA Health Cancer Institute & Outpatient Center

    Hinsdale, Illinois, 60521

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mercy Hospital

    Joplin, Missouri, 64804

  • HCA Midwest Health

    Kansas City, Missouri, 64132

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California, 90048

  • Northwest Georgia Oncology Centers, PC

    Marietta, Georgia, 30060

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • NYU Winthrop Hospital

    Mineola, New York, 11501

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

  • The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • INTEGRIS Cancer Institute of Oklahoma Proton Campus

    Oklahoma City, Oklahoma, 73142

  • Stanford Cancer Center

    Palo Alto, California, 94304

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Mayo Clinic Cancer Center

    Phoenix, Arizona, 85054

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • HealthPartners Institute, Regions Cancer Care Center

    Saint Paul, Minnesota, 55101

  • Salinas Valley Memorial Healthcare System

    Salinas, California, 93901

  • University of Utah, Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • St. Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • Orchard Healthcare Research, Inc.

    Skokie, Illinois, 60077

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794

  • H.Lee Moffitt Cancer & Research Institute (Moffitt Cancer Center)

    Tampa, Florida, 33612

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

France16 sites

  • Centre hospitalier régional universitaire (CHRU) de Besançon - Jean-Minjoz

    Besançon, 25030

  • CHU de Bordeaux Hôpital Saint André

    Bordeaux, 33000

  • Centre François Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre hospitalier universitaire (CHU) Henri-Mondor

    Créteil, 94010

  • Centre Georges-François Leclerc

    Dijon, 21079

  • Centre Léon Bérard

    Lyon, 69008

  • Institut Paoli-Calmettes Service d'Urologie

    Marseille, 13009

  • Institut de Cancérologie de Montpellier (ICM)

    Montpellier, 34298

  • Centre Antoine Lacassagne

    Nice, 06189 Nice Cedex 2

  • Hôpital Européen Georges-Pompidou (HEGP)

    Paris, 75015

  • Institut de Cancérologie de l'Ouest (ICO) - Centre René Gauducheau

    Saint-Herblain, 44805

  • CHU de Strasbourg (Les Hôpitaux Universitaires de Strasbourg)

    Strasbourg, 67091

  • IUCTO Bureau des Essais Cliniques (Institut Claudius Regaud)

    Toulouse, 31059

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, CS 30519 54519

  • Institut Gustave Roussy - Le département de Medecine oncologique

    Villejuif, 94805

Other trials in France

Australia14 sites

  • Ballarat Health Services

    Ballarat, Victoria, 3350

  • Pindara Private Hospital

    Benowa, Queensland, 4217

  • Southern Highlands Private Hospital (Cancer Centre)

    Bowral, New South Wales, 2576

  • Cairns Hospital

    Cairns, Queensland, 4870

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Peninsula Private Hospital

    Frankston, Victoria, 3199

  • Cabrini Hospital

    Malvern, Victoria, 3144

  • Hollywood Private Hospital

    Nedlands, Western Australia, 6009

  • MacQuarie University Hospital

    North Ryde, New South Wales, 2109

  • Goulburn Valley Health

    Shepparton, Victoria, 3630

  • Mater Misericordiae Limited - Division of Cancer Services

    South Brisbane, Queensland, 4101

  • Liverpool Hospital

    Sydney, New South Wales, 2170

  • Tweed Hospital

    Tweed Heads, New South Wales, 2485

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Spain13 sites

  • Hospital Universitari VHIO - Vall d'Hebron Departamento de Oncologia

    Barcelona, 08035

  • El Hospital Clínic i Provincial de Barcelona (HCPB)

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Institut Català d'Oncologia (ICO) L'Hospitalet

    Barcelona, 08908

  • Institut Català d'Oncologia

    Girona, 17007

  • HGU Gregorio Marañon

    Madrid, 28009

  • MD Anderson Cancer Center Madrid

    Madrid, 28033

  • El Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Centro Integral Oncologico Clara Campal (CIOCC) HM

    Madrid, 28050

  • Hospital Parc Taulí de Sabadell

    Sabadell, 08208

  • Hospital Universitario Virgen del Rocío

    Seville, Andalusia, 41013

  • Hospital Universitario Virgen de Macarena

    Seville, 41009

  • Fundación Instituto Valencia d'Oncología (IVO)

    Valencia, 46009

Other trials in Spain

Italy12 sites

  • Presidio Ospedaliero Antonio Perrino - U.O.C. Oncologia Medica

    Brindisi, 72100

  • S.C. Oncologia - ASST Cremona P.O. Ospedale di Cremona

    Cremona, 26100

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Istituto Europeo di Oncologia - Divisione di Oncologia Medica Urogenitale e Cervico Facciale

    Milan, 20141

  • U.O.C. ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo

    Milan, 20153

  • University of Modena and Reggio Emilia (Azienda Ospedaliera-Universitaria Policlinico Modena)

    Modena, 41124

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Naples, 80131

  • Azienda Ospedaliero Universitaria San Luigi Gonzaga

    Orbassano, 10043

  • Unità Operativa (UO) di Oncologia Medica - ICS Maugeri

    Pavia, 27100

  • U.O. Oncologia Ospedale degli Infermi - Dipartimento di Oncologia ed Ematologia

    Rimini, 47923

  • Policlinico Universitario A. Gemelli

    Roma, 00168

  • Policlinico Universitario Campus Bio-Medico

    Rome, 00128

Other trials in Italy

United Kingdom8 sites

  • Beatson West of Scotland Cancer Centre

    Glasgow, Lanarkshire, G12 0YN

  • Mount Vernon Cancer Centre

    London, Middlesex, HA6 2RN

  • St. Bartholomew's Hospital, Barts Health NHS Trust

    London, EC1A7BE

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • Sarah Cannon Research Institute UK Limited

    London, W1G 6AD

  • The Christie NHS Foundation Trust

    Manchester, Greater Manchester, M20 4BX

  • Nottingham University Hospitals NHS Trust - City Hospital Campus

    Nottingham, Nottinghamshire, NG5 1PB

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Germany7 sites

  • Charité Universitätsmedizin Berlin, Dept. of Interdisciplinary Urology

    Berlin, 10117

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik

    Dresden, 01307

  • Universitätsklinikum Essen (AöR) Westdeutsches Tumorzentrum

    Essen, 45147

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Medical University Heidelberg, NCT (National Center for Tumour Diseases), Medical Oncology

    Heidelberg, Baden-Wurttemberg, 69120

  • Technischen Universitat München - Urologische Klinik

    München, Bavaria, 81675

  • Universitätsklinikum Tübingen, Klinik für Urologie

    Tübingen, 72076

Other trials in Germany

New Zealand4 sites

  • Auckland City Hospital

    Auckland, Grafton, 1023

  • Christchurch Hospital

    Christchurch, South Island, 8011

  • Waikato Hospital

    Hamilton, 3240

  • Wellington Regional Hospital

    Wellington, 6021

Other trials in New Zealand

About this study

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)

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).

Being tested
CB-839, Cabozantinib, Placebo
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
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CB-839Drug

    Also called telaglenastat

    Oral glutaminase inhibitor

  • CabozantinibDrug

    Also called Cabometyx, Cabometriq

    Oral receptor tyrosine kinase inhibitor

  • PlaceboDrug

    Placebo tablets

Study groups in NCT03428217
Study groupRoleWhat they receive
Pbo-CaboPlacebo comparatorPlacebo 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.
Receives: Drug: Cabozantinib; Drug: Placebo
CB-CaboExperimentalCB-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.
Receives: Drug: CB-839; Drug: Cabozantinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 (2)

  1. 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.

    Measured: Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for OS was 25.86 months.

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2018
  2. Study start24 Apr 2018
  3. Primary completion31 Aug 2020
  4. Study completion16 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03428217
Sponsor's protocol ID
CX-839-008
Acronym
CANTATA
Status last verified
Feb 2023
First submitted
5 Feb 2018
Last updated
20 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36048457

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CB-839 and Cabozantinib in people with Advanced Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by Calithera Biosciences, Inc at 133 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in United States, France, Australia, Spain, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03428217, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.

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