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A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment (CONTACT-03)

Primary Purpose

Carcinoma, Renal Cell

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Cabozantinib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed locally advanced or metastatic clear cell or non-clear cell (papillary, chromophobe, and unclassified only) RCC. RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation.
  • Radiographic disease progression to prior ICI therapy for RCC. Patients who experienced radiographic tumor progression during or within 6 months after the last dose of adjuvant ICI are also eligible. ICI is defined by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, durvalumab, or nivolumab. Only patients for whom the immediate preceding line of therapy was an ICI are allowed.
  • Measurable disease per RECIST v1.1
  • Evaluable IMDC risk score
  • Archival tumor specimen, and pretreatment tumor tissue from fresh biopsy at screening, if clinically feasible. Both archival and fresh samples are preferred.
  • KPS score of >=70
  • Recovery to baseline or Grade </= 1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable in the opinion of the investigator. Grade 2 alopecia is allowed for study participation
  • Adequate hematologic and end-organ function
  • Negative HIV test at screening
  • Negative hepatitis B testing at screening
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria:

  • Treatment with anti-cancer therapy within 14 days prior to initiation of study treatment
  • Patients received cabozantinib at any time prior to screening
  • Patients who received more than one ICI treatment in the locally advanced or metastatic setting
  • Patients who received more than two prior lines of therapy in the locally advanced or metastatic setting
  • Patients who have received a mammalian target of rapamycin (mTOR) inhibitor in any setting
  • Symptomatic, untreated, or actively progressing CNS metastases
  • History of leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
  • History of malignancy other than renal carcinoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Radiotherapy for RCC within 14 days prior to Day 1 of Cycle 1
  • Active tuberculosis
  • Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after final dose of atezolizumab and 4 months after final dose of cabozantinib
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety
  • Pharmacologically uncompensated, symptomatic hypothyroidism
  • Uncontrolled hypertension defined as sustained blood pressure >150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment
  • Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, unstable arrhythmia, or unstable angina) within 3 months prior to initiation of study treatment
  • Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1
  • History of congenital QT syndrome
  • History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
  • Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g. clopidogrel)

Sites / Locations

  • University of Arizona
  • City of Hope Comprehensive Cancer Center
  • UC San Diego Health System
  • UCLA
  • University of Colorado
  • Rocky Mountain Cancer Center - Denver
  • Sibley Memorial Hospital
  • Woodlands Medical Specialists, P.A.
  • Moffitt Cancer Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building
  • MGH
  • Beth Israel Deaconess Med Ctr
  • Dana-Farber Cancer Institute
  • Minnesota Oncology Hematology
  • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
  • Memorial Sloan Kettering - Monmouth
  • Memorial Sloan Kettering Bergen
  • New York Oncology Hematology,P.C.-Albany
  • Montefiore Medical Center
  • Memorial Sloan Kettering Cancer Center - Commack
  • MSKCC @ West Harrison
  • Mount Sinai Medical Center
  • Memorial Sloan Kettering Cancer Center
  • SUNY Upstate Medical University
  • Duke University Medical Center
  • Cleveland Clinic
  • Fox Chase Cancer Center
  • Texas Onc-Central Austin CA Ct
  • University Of Utah
  • Virginia Cancer Specialists - Gainsville
  • Fundación CENIT para la Investigación en Neurociencias
  • Inst. Alexander Fleming; Oncologia
  • Hospital Britanico
  • Centro Medico Austral OMI
  • Macquarie University Hospital
  • Orange Hospital
  • Icon Cancer Foundation
  • Bendigo Cancer Centre
  • St. Joseph's Healthcare Hamilton
  • Princess Margaret Cancer Center
  • Herlev Hospital; Afdeling for Kræftbehandling
  • CHU Besançon - Hôpital Jean Minjoz
  • CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
  • Centre Francois Baclesse; Oncologie
  • Centre Jean Perrin; Oncologie
  • Centre Oscar Lambret; Chir Cancerologie General
  • Centre Leon Berard; Departement Oncologie Medicale
  • Centre Antoine Lacassagne
  • Institut de cancerologie du Gard
  • Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
  • ICANS
  • Institut Gustave Roussy; Oncologie Medicale
  • Zeisigwaldkliniken Bethanien
  • Klinikum der Johann Wolfgang Goethe-Universitaet; Urologie und Kinderurologie
  • Universitaetsklinikum Freiburg; Urology
  • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
  • Uniklinik-Eppendorf; Klinik U Poliklinik F Urologie
  • Med. Hochschule Hannover, Hämatologie, Hämostaseologie, Onkologie u. Stammzelltransplantation
  • Universitaetsklinikum Muenster; Urology
  • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
  • Universitätsklinikum Tübingen; Klinik für Urologie
  • Universitätsklinikum Ulm; Klinik für Urologie
  • Alexandras General Hospital of Athens; Oncology Department
  • Athens Medical Center; Dept. of Oncology
  • Attikon University General Hospital
  • University Hospital of Larissa;Department of Medical Oncology
  • Diavalkaniko Hospital
  • Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
  • ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
  • Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica
  • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
  • Ospedale Di Macerata; Oncologia
  • Fondazione del Piemonte per l?Oncologia (IRCCS); Day Hospital Oncologico Multidisciplinare
  • A.O. Universitaria Ospedale Consorziale Policlinico Di Bari; U.O. Oncologia Medica Universitaria
  • Azienda Ospedaliera S. Maria - Terni; Oncologia
  • A.O.U di Verona Policlinico G.B. Rossi; Centro Ricerche Cliniche
  • Kyushu University Hospital
  • Hokkaido University Hospital
  • University of Tsukuba Hospital
  • Yokohama City University Hospital
  • Okayama University Hospital
  • Osaka Metropolitan University Hospital
  • Kindai University Hospital
  • Tokushima University Hospital
  • Keio University Hospital
  • Tokyo Women's Medical University Hospital
  • Chungnam National University Hospital
  • CHA Bundang Medical Center
  • Pusan National University Yangsan Hospital
  • Chonnam National University Hwasun Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Kangbuk Samsung Medical Center
  • Severance Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
  • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
  • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
  • SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej
  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
  • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
  • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
  • Wojskowy Instytut Medyczny; Klinika Onkologii
  • Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii
  • Regional Clinical Oncology Hospital
  • St-Petersburg Regional Oncology Dispensary; Oncology
  • Branch of the company "Hadassah Medical LTD"
  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
  • MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
  • SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
  • National Medical Research Center for Surgery named after A.V. Vishnevsky
  • AV Medical Ltd.
  • Private Healthcare Institution Clinical Hospital RZhD Medicine
  • Medical Center Avicenna; Urology
  • Hospital Univ. Central de Asturias; Servicio de Oncologia
  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Hospital Universitario Son Espases; Servicio de Oncologia
  • Hospital Alvaro Cunqueiro; Servicio de Oncologia
  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Hospital Universitario de Burgos; Oncología
  • Hospital San Pedro De Alcantara; Servicio de Oncologia
  • Hospital Lucus Augusti; Servicio de Oncologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Clinico San Carlos; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
  • Hospital de Navarra; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
  • Hospital Universitario la Fe; Servicio de Oncologia
  • Royal Blackburn Hospital
  • Leicester Royal Infirmary; Dept. of Medical Oncology
  • Barts & London School of Med; Medical Oncology
  • Royal Marsden Hospital; Dept of Med-Onc
  • Christie Hospital Nhs Trust; Medical Oncology
  • Royal Marsden Hospital (Sutton)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atezo+Cabo

Cabozantinib

Arm Description

Participants will receive atezolizumab every 3 weeks on Day 1 of each 21-day cycle (1 cycle=21 days) plus oral tablets of cabozantinib every day.

Participants will receive cabozantinib every day.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS), as assessed by Independent Review Facility (IRF)
Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1, as assessed by Independent Review Facility (IRF-PFS) or death from any cause, whichever occurs first.
Overall survival (OS)
Overall survival (OS), defined as the time from randomization to death from any cause.

Secondary Outcome Measures

PFS Assessed by the Investigators (INV-PFS)
PFS assessed by the investigators (INV-PFS), defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first).
Investigator Assessed Objective Response Rate (INV-ORR)
INV-ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1.
IRF Assessed Objective Response Rate (IRF-ORR)
IRF-ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1.
Investigator Assessed Duration of Objective Response (INV-DOR)
INV-DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) according to RECIST v1.1.
IRF Assessed DOR (IRF-DOR)
IRF-DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) according to RECIST v1.1.
Percentage of Participants With Adverse Events
Atezolizumab Concentrations
Cabozantinib Concentrations
Prevalence of Anti-Drug Antibodies (ADAs) to Atezolizumab
Incidence of ADAs to Atezolizumab During the Study

Full Information

First Posted
April 6, 2020
Last Updated
September 25, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Exelixis, Chugai
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1. Study Identification

Unique Protocol Identification Number
NCT04338269
Brief Title
A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment
Acronym
CONTACT-03
Official Title
A Phase III, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination With Cabozantinib Versus Cabozantinib Alone in Patients With Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
January 3, 2023 (Actual)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Exelixis, Chugai

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
This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
522 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atezo+Cabo
Arm Type
Experimental
Arm Description
Participants will receive atezolizumab every 3 weeks on Day 1 of each 21-day cycle (1 cycle=21 days) plus oral tablets of cabozantinib every day.
Arm Title
Cabozantinib
Arm Type
Active Comparator
Arm Description
Participants will receive cabozantinib every day.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab 1200 mg will be administered at a fixed dose on Day 1 of each 21-day cycle by IV infusion every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Cabozantinib
Other Intervention Name(s)
Cabometyx
Intervention Description
Cabozantinib 60 mg (three 20-mg tablets) administered orally once daily.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS), as assessed by Independent Review Facility (IRF)
Description
Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1, as assessed by Independent Review Facility (IRF-PFS) or death from any cause, whichever occurs first.
Time Frame
Randomization up to approximately 27 months
Title
Overall survival (OS)
Description
Overall survival (OS), defined as the time from randomization to death from any cause.
Time Frame
Randomization up to approximately 52 months
Secondary Outcome Measure Information:
Title
PFS Assessed by the Investigators (INV-PFS)
Description
PFS assessed by the investigators (INV-PFS), defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first).
Time Frame
Randomization up to approximately 27 months
Title
Investigator Assessed Objective Response Rate (INV-ORR)
Description
INV-ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1.
Time Frame
Randomization up to approximately 27 months
Title
IRF Assessed Objective Response Rate (IRF-ORR)
Description
IRF-ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1.
Time Frame
Randomization up to approximately 27 months
Title
Investigator Assessed Duration of Objective Response (INV-DOR)
Description
INV-DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) according to RECIST v1.1.
Time Frame
Randomization up to approximately 27 months
Title
IRF Assessed DOR (IRF-DOR)
Description
IRF-DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) according to RECIST v1.1.
Time Frame
Randomization up to approximately 27 months
Title
Percentage of Participants With Adverse Events
Time Frame
Randomization up to approximately 27 months
Title
Atezolizumab Concentrations
Time Frame
At pre-defined intervals from first administration of study drug up to approximately 27 months
Title
Cabozantinib Concentrations
Time Frame
At pre-defined intervals from first administration of study drug up to approximately 27 months
Title
Prevalence of Anti-Drug Antibodies (ADAs) to Atezolizumab
Time Frame
Baseline
Title
Incidence of ADAs to Atezolizumab During the Study
Time Frame
At pre-defined intervals from first administration of study drug up to approximately 27 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed locally advanced or metastatic clear cell or non-clear cell (papillary, chromophobe, and unclassified only) RCC. RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation. Radiographic disease progression to prior ICI therapy for RCC. Patients who experienced radiographic tumor progression during or within 6 months after the last dose of adjuvant ICI are also eligible. ICI is defined by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, durvalumab, or nivolumab. Only patients for whom the immediate preceding line of therapy was an ICI are allowed. Measurable disease per RECIST v1.1 Evaluable IMDC risk score Archival tumor specimen, and pretreatment tumor tissue from fresh biopsy at screening, if clinically feasible. Both archival and fresh samples are preferred. KPS score of >=70 Recovery to baseline or Grade </= 1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable in the opinion of the investigator. Grade 2 alopecia is allowed for study participation Adequate hematologic and end-organ function Negative HIV test at screening Negative hepatitis B testing at screening Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm Exclusion Criteria: Treatment with anti-cancer therapy within 14 days prior to initiation of study treatment Patients received cabozantinib at any time prior to screening Patients who received more than one ICI treatment in the locally advanced or metastatic setting Patients who received more than two prior lines of therapy in the locally advanced or metastatic setting Patients who have received a mammalian target of rapamycin (mTOR) inhibitor in any setting Symptomatic, untreated, or actively progressing CNS metastases History of leptomeningeal disease Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab History of malignancy other than renal carcinoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death Radiotherapy for RCC within 14 days prior to Day 1 of Cycle 1 Active tuberculosis Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after final dose of atezolizumab and 4 months after final dose of cabozantinib Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety Pharmacologically uncompensated, symptomatic hypothyroidism Uncontrolled hypertension defined as sustained blood pressure >150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment (all countries except France); sustained BP > 140 mmHg systolic or > 90 mmHg diastolic despite optimal antihypertensive treatment (France only) Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, unstable arrhythmia, or unstable angina) within 3 months prior to initiation of study treatment Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1 History of congenital QT syndrome History or presence of an abnormal ECG that is clinically significant in the investigator's opinion Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g. clopidogrel)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5030
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UC San Diego Health System
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Center - Denver
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Woodlands Medical Specialists, P.A.
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
MGH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Med Ctr
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
Minnesota Oncology Hematology
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Memorial Sloan Kettering - Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
New York Oncology Hematology,P.C.-Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
MSKCC @ West Harrison
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Texas Onc-Central Austin CA Ct
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
University Of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Virginia Cancer Specialists - Gainsville
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155
Country
United States
Facility Name
Fundación CENIT para la Investigación en Neurociencias
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
Inst. Alexander Fleming; Oncologia
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Hospital Britanico
City
Ciudad Autonoma Bs As
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Centro Medico Austral OMI
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1019ABS
Country
Argentina
Facility Name
Macquarie University Hospital
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Orange Hospital
City
Orange
State/Province
New South Wales
ZIP/Postal Code
2800
Country
Australia
Facility Name
Icon Cancer Foundation
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Bendigo Cancer Centre
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3550
Country
Australia
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Facility Name
Herlev Hospital; Afdeling for Kræftbehandling
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besançon Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Centre Francois Baclesse; Oncologie
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin; Oncologie
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Oscar Lambret; Chir Cancerologie General
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Leon Berard; Departement Oncologie Medicale
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Institut de cancerologie du Gard
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
ICANS
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Institut Gustave Roussy; Oncologie Medicale
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Zeisigwaldkliniken Bethanien
City
Chemnitz
ZIP/Postal Code
09130
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet; Urologie und Kinderurologie
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Freiburg; Urology
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Uniklinik-Eppendorf; Klinik U Poliklinik F Urologie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Med. Hochschule Hannover, Hämatologie, Hämostaseologie, Onkologie u. Stammzelltransplantation
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Muenster; Urology
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Tübingen; Klinik für Urologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm; Klinik für Urologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Alexandras General Hospital of Athens; Oncology Department
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Athens Medical Center; Dept. of Oncology
City
Athens
ZIP/Postal Code
151 25
Country
Greece
Facility Name
Attikon University General Hospital
City
Chaidari
ZIP/Postal Code
124 62
Country
Greece
Facility Name
University Hospital of Larissa;Department of Medical Oncology
City
Larissa
ZIP/Postal Code
411 10
Country
Greece
Facility Name
Diavalkaniko Hospital
City
Thessaloniki
ZIP/Postal Code
570 01
Country
Greece
Facility Name
Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Ospedale Di Macerata; Oncologia
City
Macerata
State/Province
Marche
ZIP/Postal Code
62100
Country
Italy
Facility Name
Fondazione del Piemonte per l?Oncologia (IRCCS); Day Hospital Oncologico Multidisciplinare
City
Candiolo (TO)
State/Province
Piemonte
ZIP/Postal Code
10060
Country
Italy
Facility Name
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari; U.O. Oncologia Medica Universitaria
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria - Terni; Oncologia
City
Terni
State/Province
Umbria
ZIP/Postal Code
05100
Country
Italy
Facility Name
A.O.U di Verona Policlinico G.B. Rossi; Centro Ricerche Cliniche
City
Verona
State/Province
Veneto
ZIP/Postal Code
37134
Country
Italy
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Hokkaido University Hospital
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Yokohama City University Hospital
City
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center
City
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Medical Center
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
City
?ód?
ZIP/Postal Code
90-338
Country
Poland
Facility Name
Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
City
Brzozów
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
City
Pozna?
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
City
Warszawa
ZIP/Postal Code
04-073
Country
Poland
Facility Name
Wojskowy Instytut Medyczny; Klinika Onkologii
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii
City
Wroc?aw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Regional Clinical Oncology Hospital
City
Yaroslavl
State/Province
Jaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
St-Petersburg Regional Oncology Dispensary; Oncology
City
Kuzmolovo
State/Province
Leningrad
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Branch of the company "Hadassah Medical LTD"
City
Innovatsionnogo Tsentra Skolkovo
State/Province
Moskovskaja Oblast
ZIP/Postal Code
121205
Country
Russian Federation
Facility Name
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143422
Country
Russian Federation
Facility Name
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
National Medical Research Center for Surgery named after A.V. Vishnevsky
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
AV Medical Ltd.
City
Sait-Petersburg Sankt Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
196006
Country
Russian Federation
Facility Name
Private Healthcare Institution Clinical Hospital RZhD Medicine
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
Medical Center Avicenna; Urology
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Hospital Univ. Central de Asturias; Servicio de Oncologia
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
8208
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Reina Sofia; Servicio de Oncologia
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Son Espases; Servicio de Oncologia
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital Alvaro Cunqueiro; Servicio de Oncologia
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36213
Country
Spain
Facility Name
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario de Burgos; Oncología
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital San Pedro De Alcantara; Servicio de Oncologia
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Lucus Augusti; Servicio de Oncologia
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital de Navarra; Servicio de Oncologia
City
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Oncologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Royal Blackburn Hospital
City
Blackburn
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Facility Name
Leicester Royal Infirmary; Dept. of Medical Oncology
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Barts & London School of Med; Medical Oncology
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Marsden Hospital; Dept of Med-Onc
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Christie Hospital Nhs Trust; Medical Oncology
City
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom
Facility Name
Royal Marsden Hospital (Sutton)
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Citations:
PubMed Identifier
35304832
Citation
Yang Y, Psutka SP, Parikh AB, Li M, Collier K, Miah A, Mori SV, Hinkley M, Tykodi SS, Hall E, Thompson JA, Yin M. Combining immune checkpoint inhibition plus tyrosine kinase inhibition as first and subsequent treatments for metastatic renal cell carcinoma. Cancer Med. 2022 Aug;11(16):3106-3114. doi: 10.1002/cam4.4679. Epub 2022 Mar 18.
Results Reference
derived

Learn more about this trial

A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment

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