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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04338269

Studienbeginn:
Juli 2020

Letztes Update:
15.02.2021

Wirkstoff:
Atezolizumab, Cabozantinib

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Renal Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Hoffmann-La Roche

Collaborator:
Exelixis, Chugai,

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: WO41994 www.roche.com/about_roche/roche_worldwide.htm
Kontakt:
Phone: 888-662-6728 (U.S. and Canada)
E-Mail: global-roche-genentech-trials@gene.com
» Kontaktdaten anzeigen

Studienlocations (3 von 169)

Darmzentrum Zeisigwaldkliniken Bethanien
Zeisigwaldstraße 101
9130 Chemnitz
DeutschlandRekrutierend» Google-Maps
Klinikum der Johann Wolfgang Goethe-Universitaet; Urologie und Kinderurologie
60590 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Freiburg; Urology
79106 Freiburg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
06120 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Uniklinik-Eppendorf; Klinik U Poliklinik F Urologie
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Med. Hochschule Hannover, Hämatologie, Hämostaseologie, Onkologie u. Stammzelltransplantation
30625 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Muenster; Urology
48149 Muenster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
81675 München
(Bayern)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Tübingen; Klinik für Urologie
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Ulm; Klinik für Urologie
89081 Ulm
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Arizona Oncology Associates
86001 Flagstaff
United StatesRekrutierend» Google-Maps
University of Arizona
85724-5030 Tucson
United StatesRekrutierend» Google-Maps
City of Hope Comprehensive Cancer Center
91010 Duarte
United StatesRekrutierend» Google-Maps
UC San Diego Health System
92093 La Jolla
United StatesRekrutierend» Google-Maps
University of Southern California
90033 Los Angeles
United StatesZurückgezogen» Google-Maps
University of California Davis
95817 Sacramento
United StatesZurückgezogen» Google-Maps
University of California San Francisco
94117 San Francisco
United StatesNoch nicht rekrutierend» Google-Maps
Highlands Ranch Hospital
80129 Highlands Ranch
United StatesRekrutierend» Google-Maps
Rocky Mountain Cancer Center - Denver
80120 Littleton
United StatesRekrutierend» Google-Maps
Sibley Memorial Hospital
20016 Washington
United StatesNoch nicht rekrutierend» Google-Maps
Woodlands Medical Specialists, P.A.
32503 Pensacola
United StatesRekrutierend» Google-Maps
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building
21287 Baltimore
United StatesNoch nicht rekrutierend» Google-Maps
Beth Israel Deaconess Med Ctr
02215 Boston
United StatesNoch nicht rekrutierend» Google-Maps
Dana-Farber Cancer Institute
02215 Boston
United StatesNoch nicht rekrutierend» Google-Maps
Minnesota Oncology Hematology
55404 Minneapolis
United StatesRekrutierend» Google-Maps
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
89169 Las Vegas
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering - Monmouth
07748 Middletown
United StatesNoch nicht rekrutierend» Google-Maps
Memorial Sloan Kettering Bergen
07645 Montvale
United StatesNoch nicht rekrutierend» Google-Maps
New York Oncology Hematology,P.C.-Albany
12208 Albany
United StatesRekrutierend» Google-Maps
Montefiore Medical Center
10461 Bronx
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center - Commack
11725 Commack
United StatesNoch nicht rekrutierend» Google-Maps
MSKCC @ West Harrison
10604 Harrison
United StatesNoch nicht rekrutierend» Google-Maps
New York University
10017 New York
United StatesZurückgezogen» Google-Maps
Mount Sinai Medical Center
10029 New York
United StatesNoch nicht rekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesNoch nicht rekrutierend» Google-Maps
SUNY Upstate Medical University
13210 Syracuse
United StatesRekrutierend» Google-Maps
Duke University Medical Center
27710 Durham
United StatesNoch nicht rekrutierend» Google-Maps
Willamette Valley Cancer Institute and Research Center
97401 Eugene
United StatesRekrutierend» Google-Maps
Fox Chase Cancer Center
19111 Philadelphia
United StatesRekrutierend» Google-Maps
Texas Onc-Central Austin CA Ct
78731 Austin
United StatesAktiv, nicht rekrutierend» Google-Maps
Texas Oncology - Houston (Gessner)
77024 Houston
United StatesRekrutierend» Google-Maps
Texas Oncology - Willowbrook
77070 Houston
United StatesRekrutierend» Google-Maps
University Of Utah
84108 Salt Lake City
United StatesRekrutierend» Google-Maps
Virginia Cancer Specialists - Gainsville
20155 Gainesville
United StatesRekrutierend» Google-Maps
Virginia Oncology Associates
23502 Norfolk
United StatesRekrutierend» Google-Maps
University of Wisconsin
53792 Madison
United StatesNoch nicht rekrutierend» Google-Maps
Fundación CENIT para la Investigación en Neurociencias
C1125ABD Buenos Aires
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Inst. Alexander Fleming; Oncologia
C1426ANZ Buenos Aires
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Hospital Britanico
C1280AEB Ciudad Autonoma Bs As
ArgentinaRekrutierend» Google-Maps
Centro Medico Austral OMI
C1019ABS Ciudad Autonoma Buenos Aires
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Macquarie University Hospital
2109 Macquarie Park
AustraliaRekrutierend» Google-Maps
Icon Cancer Foundation
4101 South Brisbane
AustraliaRekrutierend» Google-Maps
Box Hill Hospital; Oncology
3128 Box Hill
AustraliaNoch nicht rekrutierend» Google-Maps
Cancer Care Manitoba
R3E 0V9 Winnipeg
CanadaNoch nicht rekrutierend» Google-Maps
Princess Margaret Cancer Center
M5G 1Z5 Toronto
CanadaNoch nicht rekrutierend» Google-Maps
Herlev Hospital; Afdeling for Kræftbehandling
2730 Herlev
DenmarkNoch nicht rekrutierend» Google-Maps
Odense Universitetshospital, Onkologisk Afdeling R
5000 Odense C
DenmarkNoch nicht rekrutierend» Google-Maps
CHU Besançon - Hôpital Jean Minjoz
25030 Besançon Cedex
FranceNoch nicht rekrutierend» Google-Maps
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
33075 Bordeaux
FranceNoch nicht rekrutierend» Google-Maps
Centre Francois Baclesse; Oncologie
14076 Caen
FranceNoch nicht rekrutierend» Google-Maps
Centre Jean Perrin; Oncologie
63011 Clermont Ferrand
FranceNoch nicht rekrutierend» Google-Maps
Centre Oscar Lambret; Chir Cancerologie General
59000 Lille
FranceNoch nicht rekrutierend» Google-Maps
Centre Leon Berard; Departement Oncologie Medicale
69373 Lyon
FranceNoch nicht rekrutierend» Google-Maps
Centre Antoine Lacassagne
06189 Nice
FranceNoch nicht rekrutierend» Google-Maps
Institut de cancerologie du Gard
30029 Nimes
FranceNoch nicht rekrutierend» Google-Maps
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
75908 Paris
FranceNoch nicht rekrutierend» Google-Maps
Hopital Hautepierre; Hematologie Oncologie
67098 Strasbourg
FranceNoch nicht rekrutierend» Google-Maps
Institut Claudius Regaud; Departement Oncologie Medicale
31059 Toulouse
FranceZurückgezogen» Google-Maps
Institut Gustave Roussy; Oncologie Medicale
94800 Villejuif
FranceNoch nicht rekrutierend» Google-Maps
Alexandras General Hospital of Athens; Oncology Department
115 28 Athens
GreeceRekrutierend» Google-Maps
Attikon University General Hospital
124 64 Athens
GreeceRekrutierend» Google-Maps
Athens Medical Center; Dept. of Oncology
151 25 Athens
GreeceRekrutierend» Google-Maps
University Hospital of Larissa;Department of Medical Oncology
411 10 Larissa
GreeceNoch nicht rekrutierend» Google-Maps
Papageorgiou General Hospital; Medical Oncology
564 29 Thessaloniki
GreeceNoch nicht rekrutierend» Google-Maps
Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
80131 Napoli
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
40138 Bologna
ItalyRekrutierend» Google-Maps
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
47014 Meldola
ItalyRekrutierend» Google-Maps
Irccs Centro Di Riferimento Oncologico (CRO); SOC Oncologia Medica A
33081 Aviano (PN)
ItalyNoch nicht rekrutierend» Google-Maps
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
00168 Roma
ItalyRekrutierend» Google-Maps
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
25123 Brescia
ItalyRekrutierend» Google-Maps
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
20133 Milano
ItalyRekrutierend» Google-Maps
Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica
27100 Pavia
ItalyRekrutierend» Google-Maps
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
20089 Rozzano
ItalyRekrutierend» Google-Maps
Ospedale Di Macerata; Oncologia
62100 Macerata
ItalyRekrutierend» Google-Maps
Fondazione del Piemonte per l'Oncologia (IRCCS); Day Hospital Oncologico Multidisciplinare
10060 Candiolo (TO)
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera S. Maria - Terni; Oncologia
05100 Terni
ItalyRekrutierend» Google-Maps
Hokkaido University Hospital
060-8648 Hokkaido
JapanRekrutierend» Google-Maps
University of Tsukuba Hospital
305-8576 Ibaraki
JapanRekrutierend» Google-Maps
Yokohama City University Hospital
236-0004 Kanagawa
JapanRekrutierend» Google-Maps
Okayama University Hospital
700-8558 Okayama
JapanRekrutierend» Google-Maps
Osaka City University Hospital
545-8586 Osaka
JapanRekrutierend» Google-Maps
Kindai University Hospital
589-8511 Osaka
JapanNoch nicht rekrutierend» Google-Maps
Tokushima University Hospital
770-8503 Tokushima
JapanRekrutierend» Google-Maps
Tokyo Women's Medical University Hospital
162-8666 Tokyo
JapanRekrutierend» Google-Maps
Chungnam National University Hospital
35015 Daejeon
Korea, Republic ofRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
CHA Bundang Medical Center
13496 Gyeonggi-do
Korea, Republic ofRekrutierend» Google-Maps
Pusan National University Yangsan Hospital
50612 Gyeongsangnam-do
Korea, Republic ofRekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Jeollanam-do
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13605 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
(0)6351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Kangbuk Samsung Medical Center
03181 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
36-200 Brzozów
PolandRekrutierend» Google-Maps
Centrum Onkologii im. Prof. Franciszka Łukaszczyka; Ambulatorium Chemioterapii
85-796 Bydgoszcz
PolandRekrutierend» Google-Maps
SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej
41-902 Bytom
PolandRekrutierend» Google-Maps
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
05-400 Otwock
PolandRekrutierend» Google-Maps
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
60-570 Poznan
PolandRekrutierend» Google-Maps
Lecznice Citomed Sp. z o.o.
87-100 Torun
PolandNoch nicht rekrutierend» Google-Maps
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.
04-073 Warszawa
PolandRekrutierend» Google-Maps
Wojskowy Instytut Medyczny; Klinika Onkologii
04-141 Warszawa
PolandNoch nicht rekrutierend» Google-Maps
Dolnoslaskie Centrum Onkologii
53-413 Wrocław
PolandRekrutierend» Google-Maps
Regional Clinical Oncology Hospital
150054 Yaroslavl
Russian FederationNoch nicht rekrutierend» Google-Maps
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
143422 Moscow
Russian FederationAktiv, nicht rekrutierend» Google-Maps
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
111123 Moskva
Russian FederationRekrutierend» Google-Maps
Private Healthcare Institution Clinical Hospital RZhD Medicine
195271 St. Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
TSBHI Altai Territorial oncological dispensary
656045 Barnaul
Russian FederationRekrutierend» Google-Maps
St-Petersburg Regional Oncology Dispensary; Oncology
188663 Kuzmolovo
Russian FederationNoch nicht rekrutierend» Google-Maps
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
115478 Moscow
Russian FederationRekrutierend» Google-Maps
Russian Scientific Center of Roentgenoradiology
117997 Moscow
Russian FederationRekrutierend» Google-Maps
Medical Center Avicenna; Urology
630099 Novosibirsk
Russian FederationRekrutierend» Google-Maps
FSI Russian Centre of Radiology and Surgical Technologies
197758 Saint-Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Hospital Univ. Central de Asturias; Servicio de Oncologia
33011 Oviedo
SpainRekrutierend» Google-Maps
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
8208 Sabadell
SpainRekrutierend» Google-Maps
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
39008 Santander
SpainRekrutierend» Google-Maps
Hospital Universitario Reina Sofia; Servicio de Oncologia
14004 Córdoba
SpainRekrutierend» Google-Maps
Hospital Universitario Son Espases; Servicio de Oncologia
07014 Palma De Mallorca
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
28222 Majadahonda
SpainRekrutierend» Google-Maps
Hospital Alvaro Cunqueiro; Servicio de Oncologia
36213 Vigo
SpainRekrutierend» Google-Maps
Hospital Univ Vall d'Hebron; Servicio de Oncologia
08035 Barcelona
SpainNoch nicht rekrutierend» Google-Maps
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
08041 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario de Burgos; Oncología
09006 Burgos
SpainRekrutierend» Google-Maps
Hospital San Pedro De Alcantara; Servicio de Oncologia
10003 Caceres
SpainNoch nicht rekrutierend» Google-Maps
Hospital Lucus Augusti; Servicio de Oncologia
27003 Lugo
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
28007 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Ramon y Cajal; Servicio de Oncologia
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Clinico San Carlos; Servicio de Oncologia
28040 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre; Servicio de Oncologia
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario La Paz; Servicio de Oncologia
28046 Madrid
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
29010 Malaga
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
30120 Murcia
SpainNoch nicht rekrutierend» Google-Maps
Hospital de Navarra; Servicio de Oncologia
31008 Navarra
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
41013 Sevilla
SpainRekrutierend» Google-Maps
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
41014 Sevilla
SpainRekrutierend» Google-Maps
Instituto Valenciano Oncologia; Oncologia Medica
46009 Valencia
SpainRekrutierend» Google-Maps
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
46015 Valencia
SpainRekrutierend» Google-Maps
Hospital Universitario la Fe; Servicio de Oncologia
46026 Valencia
SpainRekrutierend» Google-Maps
Royal Blackburn Hospital
BB2 3HH Blackburn
United KingdomNoch nicht rekrutierend» Google-Maps
Leicester Royal Infirmary; Dept. of Medical Oncology
LE1 5WW Leicester
United KingdomRekrutierend» Google-Maps
Barts & London School of Med; Medical Oncology
EC1A 7BE London
United KingdomNoch nicht rekrutierend» Google-Maps
St George's Hospital; Oncology
SW17 0QT London
United KingdomNoch nicht rekrutierend» Google-Maps
Royal Marsden Hospital; Dept of Med-Onc
SW3 6JJ London
United KingdomNoch nicht rekrutierend» Google-Maps
Christie Hospital Nhs Trust; Medical Oncology
M2O 4BX Manchester
United KingdomNoch nicht rekrutierend» Google-Maps
ROYAL MARSDEN HOSPITAL; DEPT OF MEDICAL ONCOLOGY; The Bob Champion Unit
SM2 5PT Sutton
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed locally advanced or metastatic clear cell or non-clear cell

(papillary and unclassified only) RCC. RCC with sarcomatoid features is allowed.

- Radiographic disease progression during or following treatment with ICI for locally

advanced or metastatic RCC either in first- or second-line treatment. ICI is defined

by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, 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

- KPS score of >=70

- 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 28 days prior to initiation of study

treatment

- Patients received cabozantinib at any time prior to screening

- Patients who received more than 1 regimen of ICIs

- Patients who received more than 2 prior lines of therapy in the advanced or metastatic

setting

- Patients who received ICI in the adjuvant setting (adjuvant VEGFR-TKI except

cabozantinib is allowed)

- Patients who have received a mammalian target of rapamycin (mTOR) inhibitor in the

advanced or metastatic 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

- 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, MI, or cerebrovascular accident) within 3 months prior to

initiation of study treatment, unstable arrhythmia, or unstable angina

- Significant vascular disease (e.g., aortic aneurysm 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)

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS), as assessed by Independent Review Facility (IRF) (Time Frame - Randomization up to approximately 27 months):
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.

2. Overall survival (OS) (Time Frame - Randomization up to approximately 52 months):
Overall survival (OS), defined as the time from randomization to death from any cause.

Secondary outcome:

1. PFS Assessed by the Investigators (INV-PFS) (Time Frame - Randomization up to approximately 27 months):
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).

2. Investigator Assessed Objective Response Rate (INV-ORR) (Time Frame - Randomization up to approximately 27 months):
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.

3. IRF Assessed Objective Response Rate (IRF-ORR) (Time Frame - Randomization up to approximately 27 months):
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.

4. Investigator Assessed Duration of Objective Response (INV-DOR) (Time Frame - Randomization up to approximately 27 months):
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.

5. IRF Assessed DOR (IRF-DOR) (Time Frame - Randomization up to approximately 27 months):
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.

6. Percentage of Participants With Adverse Events (Time Frame - Randomization up to approximately 27 months)

7. Atezolizumab Concentrations (Time Frame - At pre-defined intervals from first administration of study drug up to approximately 27 months)

8. Cabozantinib Concentrations (Time Frame - At pre-defined intervals from first administration of study drug up to approximately 27 months)

9. Prevalence of Anti-Drug Antibodies (ADAs) to Atezolizumab (Time Frame - Baseline)

10. 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)

Studien-Arme

  • Experimental: Atezo+Cabo
    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.
  • Active Comparator: Cabozantinib
    Participants will receive cabozantinib every day.

Geprüfte Regime

  • Atezolizumab (Tecentriq):
    Atezolizumab 1200 mg will be administered at a fixed dose on Day 1 of each 21-day cycle by IV infusion every 3 weeks.
  • Cabozantinib (Cabometyx):
    Cabozantinib 60 mg (three 20-mg tablets) administered orally once daily.

Quelle: ClinicalTrials.gov


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