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)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Carcinoma, Renal Cell
• Intervention / Treatment: Drug: Atezolizumab; Drug: Cabozantinib

• Study Type: Interventional
• Enrollment (Actual): 522
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125ABD
    • Fundación CENIT para la Investigación en Neurociencias
  • Buenos Aires, Argentina, C1426ANZ
    • Inst. Alexander Fleming; Oncologia
  • Ciudad Autonoma Bs As, Argentina, C1280AEB
    • Hospital Británico
  • Ciudad Autonoma Buenos Aires, Argentina, C1019ABS
    • Centro Medico Austral OMI
• Australia
  • New South Wales
    • Macquarie Park, New South Wales, Australia, 2109
      • Macquarie University Hospital
    • Orange, New South Wales, Australia, 2800
      • Orange Hospital
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Foundation
  • Victoria
    • Bendigo, Victoria, Australia, 3550
      • Bendigo Cancer Centre
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton
    • Toronto, Ontario, Canada, M5G 1Z5
      • Princess Margaret Cancer Center
• Denmark
  • Herlev, Denmark, 2730
    • Herlev Hospital; Afdeling for Kræftbehandling
• France
  • Besançon Cedex, France, 25030
    • CHU Besançon - Hôpital Jean Minjoz
  • Bordeaux, France, 33075
    • CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
  • Caen, France, 14076
    • Centre Francois Baclesse; Oncologie
  • Clermont Ferrand, France, 63011
    • Centre Jean Perrin; Oncologie
  • Lille, France, 59000
    • Centre Oscar Lambret; Chir Cancerologie General
  • Lyon, France, 69373
    • Centre Leon Berard; Departement Oncologie Medicale
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Nimes, France, 30029
    • Institut de Cancérologie du Gard
  • Paris, France, 75908
    • Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
  • Strasbourg, France, 67200
    • ICANS
  • Villejuif, France, 94800
    • Institut Gustave Roussy; Oncologie Medicale
• Germany
  • Chemnitz, Germany, 09130
    • Zeisigwaldkliniken Bethanien
  • Frankfurt, Germany, 60590
    • Klinikum der Johann Wolfgang Goethe-Universitaet; Urologie und Kinderurologie
  • Freiburg, Germany, 79106
    • Universitaetsklinikum Freiburg; Urology
  • Halle (Saale), Germany, 06120
    • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
  • Hamburg, Germany, 20246
    • Uniklinik-Eppendorf; Klinik U Poliklinik F Urologie
  • Hannover, Germany, 30625
    • Med. Hochschule Hannover, Hämatologie, Hämostaseologie, Onkologie u. Stammzelltransplantation
  • Muenster, Germany, 48149
    • Universitaetsklinikum Muenster; Urology
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen; Klinik für Urologie
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm; Klinik für Urologie
• Greece
  • Athens, Greece, 115 28
    • Alexandras General Hospital of Athens; Oncology Department
  • Athens, Greece, 151 25
    • Athens Medical Center; Dept. of Oncology
  • Chaidari, Greece, 124 62
    • Attikon University General Hospital
  • Larissa, Greece, 411 10
    • University Hospital of Larissa;Department of Medical Oncology
  • Thessaloniki, Greece, 570 01
    • Diavalkaniko Hospital
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
    • Meldola, Emilia-Romagna, Italy, 47014
      • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
      • ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
    • Milano, Lombardia, Italy, 20133
      • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
    • Pavia, Lombardia, Italy, 27100
      • Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica
    • Rozzano, Lombardia, Italy, 20089
      • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
  • Marche
    • Macerata, Marche, Italy, 62100
      • Ospedale Di Macerata; Oncologia
  • Piemonte
    • Candiolo (TO), Piemonte, Italy, 10060
      • Fondazione del Piemonte per l?Oncologia (IRCCS); Day Hospital Oncologico Multidisciplinare
  • Puglia
    • Bari, Puglia, Italy, 70124
      • A.O. Universitaria Ospedale Consorziale Policlinico Di Bari; U.O. Oncologia Medica Universitaria
  • Umbria
    • Terni, Umbria, Italy, 05100
      • Azienda Ospedaliera S. Maria - Terni; Oncologia
  • Veneto
    • Verona, Veneto, Italy, 37134
      • A.O.U di Verona Policlinico G.B. Rossi; Centro Ricerche Cliniche
• Japan
  • Hokkaido, Japan, 060-8648
    • Hokkaido University Hospital
  • Ibaraki, Japan, 305-8576
    • University of Tsukuba Hospital
  • Kanagawa, Japan, 236-0004
    • Yokohama City University Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital
  • Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Tokyo, Japan, 162-8666
    • Tokyo Women's Medical University Hospital
  • Tokyo, Japan, 160-8582
    • Keio University Hospital
• Korea, Republic of
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Gyeonggi-do, Korea, Republic of, 13496
    • CHA Bundang Medical Center
  • Gyeongsangnam-do, Korea, Republic of, 50612
    • Pusan National University Yangsan Hospital
  • Jeollanam-do, Korea, Republic of, 58128
    • Chonnam National University Hwasun Hospital
  • Seongnam-si, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Medical Center
• Poland
  • ?ód?, Poland, 90-338
    • Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
  • Brzozów, Poland, 36-200
    • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
  • Bytom, Poland, 41-902
    • SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej
  • Otwock, Poland, 05-400
    • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
  • Pozna?, Poland, 60-569
    • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
  • Warszawa, Poland, 04-141
    • Wojskowy Instytut Medyczny; Klinika Onkologii
  • Warszawa, Poland, 04-073
    • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
  • Wroc?aw, Poland, 53-413
    • Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii
• Russian Federation
  • Novosibirsk, Russian Federation, 630099
    • Medical Center Avicenna; Urology
  • Jaroslavl
    • Yaroslavl, Jaroslavl, Russian Federation, 150054
      • Regional Clinical Oncology Hospital
  • Leningrad
    • Kuzmolovo, Leningrad, Russian Federation, 188663
      • St-Petersburg Regional Oncology Dispensary; Oncology
  • Moskovskaja Oblast
    • Innovatsionnogo Tsentra Skolkovo, Moskovskaja Oblast, Russian Federation, 121205
      • Branch of the company "Hadassah Medical LTD"
    • Moscow, Moskovskaja Oblast, Russian Federation, 143422
      • MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
    • Moscow, Moskovskaja Oblast, Russian Federation, 115478
      • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
    • Moskva, Moskovskaja Oblast, Russian Federation, 111123
      • SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
    • Moskva, Moskovskaja Oblast, Russian Federation, 117997
      • National Medical Research Center for Surgery named after A.V. Vishnevsky
  • Sankt Petersburg
    • Sait-Petersburg Sankt Petersburg, Sankt Petersburg, Russian Federation, 196006
      • AV Medical Ltd.
    • St. Petersburg, Sankt Petersburg, Russian Federation, 195271
      • Private Healthcare Institution Clinical Hospital RZhD Medicine
• Spain
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Barcelona, Spain, 08035
    • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos; Oncología
  • Caceres, Spain, 10003
    • Hospital San Pedro De Alcantara; Servicio de Oncologia
  • Lugo, Spain, 27003
    • Hospital Lucus Augusti; Servicio de Oncologia
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos; Servicio de Oncologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz; Servicio de Oncologia
  • Malaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
  • Navarra, Spain, 31008
    • Hospital de Navarra; Servicio de Oncologia
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Valencia, Spain, 46026
    • Hospital Universitario la Fe; Servicio de Oncologia
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Univ. Central de Asturias; Servicio de Oncologia
  • Barcelona
    • Sabadell, Barcelona, Spain, 8208
      • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07014
      • Hospital Universitario Son Espases; Servicio de Oncologia
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36213
      • Hospital Alvaro Cunqueiro; Servicio de Oncologia
• United Kingdom
  • Blackburn, United Kingdom, BB2 3HH
    • Royal Blackburn Hospital
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary; Dept. of Medical Oncology
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital; Dept of Med-Onc
  • London, United Kingdom, EC1A 7BE
    • Barts & London School of Med; Medical Oncology
  • Manchester, United Kingdom, M2O 4BX
    • Christie Hospital Nhs Trust; Medical Oncology
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital (Sutton)
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724-5030
      • University of Arizona
  • California
    • Duarte, California, United States, 91010
      • City of Hope Comprehensive Cancer Center
    • La Jolla, California, United States, 92093
      • UC San Diego Health System
    • Los Angeles, California, United States, 90095
      • UCLA
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Littleton, Colorado, United States, 80120
      • Rocky Mountain Cancer Center - Denver
  • Florida
    • Pensacola, Florida, United States, 32503
      • Woodlands Medical Specialists, P.A.
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Med Ctr
    • Boston, Massachusetts, United States, 02114
      • MGH
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • Minnesota Oncology Hematology
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
  • New Jersey
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering - Monmouth
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen
  • New York
    • Albany, New York, United States, 12208
      • New York Oncology Hematology,P.C.-Albany
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Cancer Center - Commack
    • Harrison, New York, United States, 10604
      • MSKCC @ West Harrison
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Onc-Central Austin CA Ct
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah
  • Virginia
    • Gainesville, Virginia, United States, 20155
      • Virginia Cancer Specialists - Gainsville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Atezolizumab; Atezolizumab 1200 mg will be administered at a fixed dose on Day 1 of each 21-day cycle by IV infusion every 3 weeks.; Other Names: Tecentriq; Drug: Cabozantinib; Cabozantinib 60 mg (three 20-mg tablets) administered orally once daily.; Other Names: Cabometyx
Active Comparator: Cabozantinib; Participants will receive cabozantinib every day.	Drug: Cabozantinib; Cabozantinib 60 mg (three 20-mg tablets) administered orally once daily.; Other Names: Cabometyx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) as Assessed by an Independent Review Facility (IRF) (IRF-PFS) According to RECIST v1.1	Progression Free Survival (PFS) is defined as the time from randomization to disease progression, as determined by the Independent Review Facility (IRF) per RECIST v1.1, or death from any cause, whichever occurs first. Data for patients who have not experienced disease progression or death were censored at the last tumor assessment date. Data for patients with no postbaseline tumor assessments were censored at the randomization date.	From randomization to the first occurrence of disease progression according to RECIST v1.1 (up to 2 years 5 months).
Overall Survival (OS)	From randomization to death due to any cause. Data for patients who are not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Patients who do not have post-baseline information were censored at the date of randomization.	From randomization to death due to any cause (up to 2 years 5 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) as Assessed by Investigators (INV-PFS), According to RECIST v1.1	Progression Free Survival (PFS) is defined as the time from randomization to disease progression, as determined by the Investigators per RECIST v1.1, or death from any cause, whichever occurs first. Data for patients who have not experienced disease progression or death were censored at the last tumor assessment date. Data for patients with no postbaseline tumor assessments were censored at the randomization date.	From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).
Investigator-assessed Overall Response Rate (ORR) (INV-ORR) According to RECIST v1.1	Overall Response Rate (ORR) is defined as the proportion of participants who had an objective response (complete response [CR] or partial response [PR]) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1. in the ORR evaluable population, defined as patients with measurable disease at baseline.	From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).
Independent Review Facility (IRF)-Assessed Overall Response Rate (ORR) (IRF-ORR) According to RECIST v1.1	Overall Response Rate (ORR) is defined as the proportion of participants who had an objective response (complete response [CR] or partial response [PR]) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1. in the ORR evaluable population, defined as patients with measurable disease at baseline.	From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).
Investigator-assessed Duration of Response (DOR) (INV-DOR) According to RECIST v1.1	Duration of Response (DOR) is defined as the time from the first occurrence of a confirmed objective response (complete response [CR] or partial response [PR]) to disease progression, or death, whichever occurs first. Data for participants who have not experienced disease progression or death will be censored at the last tumor assessment date. If no tumor assessments were performed after the date of the first occurrence of CR or PR, data for DOR will be censored at the date of the first occurrence of CR or PR.	From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 2 years 5 months)
Independent Review Facility (IRF)-Assessed Duration of Response (DOR) (IRF-DOR) According to RECIST v1.1	Duration of Response (DOR) is defined as the time from the first occurrence of a confirmed objective response (complete response [CR] or partial response [PR]) to disease progression, or death, whichever occurs first. Data for participants who have not experienced disease progression or death will be censored at the last tumor assessment date. If no tumor assessments were performed after the date of the first occurrence of CR or PR, data for DOR will be censored at the date of the first occurrence of CR or PR.	From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 2 years 5 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Exelixis; Chugai
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Actual): January 3, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Atezolizumab
• Other Study ID Numbers: WO41994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No