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: Terminated
• 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
    • Fundacion CENIT para la investigación en Neurociencias
  • Buenos Aires, Argentina, C1426ANZ
    • Inst. Alexander Fleming
  • Ciudad Autonoma Bs As, Argentina, C1280AEB
    • Hospital Britanico
  • 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
• France
  • Besançon, 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
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Lille, France, 59000
    • Centre Oscar Lambret
  • Lyon, France, 69373
    • Centre Leon Berard
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Paris, France, 75908
    • Hôpital Européen Georges Pompidou
  • Strasbourg, France, 67200
    • ICANS
  • Villejuif, France, 94800
    • Institut Gustave Roussy
• Germany
  • Chemnitz, Germany, 09130
    • Zeisigwaldkliniken Bethanien
  • Frankfurt, Germany, 60590
    • Klinikum Der Johann Wolfgang Goethe-Universitaet
  • Freiburg im Breisgau, Germany, 79106
    • Universitaetsklinikum Freiburg
  • Halle, Germany, 06120
    • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
  • Hamburg, Germany, 20246
    • Uniklinik-Eppendorf
  • Hanover, Germany, 30625
    • Med. Hochschule Hannover, Hämatologie, Hämostaseologie, Onkologie u. Stammzelltransplantation
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU München
  • Münster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm
• Greece
  • Athens, Greece, 12464
    • Attikon University General Hospital
  • Athens, Greece, 151 25
    • Athens Medical Center
  • Athens, Greece, 115 28
    • Alexandras General Hospital of Athens
  • Larissa, Greece, 41110
    • University Hospital of Larissa
  • Thessaloniki, Greece, 570 01
    • Diavalkaniko Hospital
• Italy
  • Apulia
    • Bari, Apulia, Italy, 70124
      • A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
  • Campania
    • Napoli, Campania, Italy, 80131
      • Istituto Tumori Napoli
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi
    • Meldola, Emilia-Romagna, Italy, 47014
      • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Policlinico Universitario "Agostino Gemelli"
  • Lombardy
    • Brescia, Lombardy, Italy, 25123
      • ASST degli Spedali Civili di Brescia
    • Milan, Lombardy, Italy, 20133
      • Irccs Istituto Nazionale Dei Tumori (Int)
    • Pavia, Lombardy, Italy, 27100
      • Fondazione Salvatore Maugeri
    • Rozzano, Lombardy, Italy, 20089
      • Istituto Clinico Humanitas
  • Piedmont
    • Candiolo (TO), Piedmont, Italy, 10060
      • Fondazione del Piemonte per l?Oncologia (IRCCS)
  • The Marches
    • Macerata, The Marches, Italy, 62100
      • Ospedale Di Macerata
  • Umbria
    • Terni, Umbria, Italy, 05100
      • Azienda Ospedaliera S. Maria - Terni
  • Veneto
    • Verona, Veneto, Italy, 37134
      • A.O.U di Verona Policlinico G.B. Rossi
• 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
• 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
  • Bytom, Poland, 41-902
    • SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4
  • Otwock, Poland, 05-400
    • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
  • Późna, Poland, 60-569
    • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu
  • Warsaw, Poland, 04-141
    • Wojskowy Instytut Medyczny
  • Warsaw, 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
• Russia
  • Novosibirsk, Russia, 630099
    • Medical Center Avicenna
  • Leningrad
    • Kuzmolovo, Leningrad, Russia, 188663
      • St-Petersburg Regional Oncology Dispensary
  • Moscow Oblast
    • Innovatsionnogo Tsentra Skolkovo, Moscow Oblast, Russia, 121205
      • Branch of the company "Hadassah Medical LTD"
    • Moscow, Moscow Oblast, Russia, 143422
      • MEDSI Clinical Hospital on Pyatnitsky Highway
    • Moscow, Moscow Oblast, Russia, 115478
      • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
    • Moskva, Moscow Oblast, Russia, 111123
      • SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
    • Moskva, Moscow Oblast, Russia, 117997
      • National Medical Research Center for Surgery named after A.V. Vishnevsky
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 195271
      • Private Healthcare Institution Clinical Hospital RZhD Medicine
    • Saint Petersburg, Sankt-Peterburg, Russia, 199034
      • AV Medical Ltd.
  • Yaroslavl Oblast
    • Yaroslavl, Yaroslavl Oblast, Russia, 150054
      • Regional Clinical Oncology Hospital
• South Korea
  • Daejeon, South Korea, 35015
    • Chungnam National University Hospital
  • Gyeonggi-do, South Korea, 13496
    • CHA Bundang Medical Center
  • Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Gyeongsangnam-do, South Korea, 50612
    • Pusan National University Yangsan Hospital
  • Jeollanam-do, South Korea, 58128
    • Chonnam National University Hwasun Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital
  • Seoul, South Korea, 006351
    • Samsung Medical Center
• Spain
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 08035
    • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcantara
  • Lugo, Spain, 27003
    • Hospital Lucus Augusti
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de Arrixaca
  • Málaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46026
    • Hospital Universitario La Fe
  • Balearic Islands
    • Palma de Mallorca, Balearic Islands, Spain, 07014
      • Hospital Universitario Son Espases
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia
  • Navarre
    • Navarra, Navarre, Spain, 31008
      • Hospital De Navarra
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36213
      • Hospital Álvaro Cunqueiro
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33011
      • Hospital Univ. Central de Asturias
• United Kingdom
  • Blackburn, United Kingdom, BB2 3HH
    • Royal Blackburn Hospital
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital
  • London, United Kingdom, EC1A 7BE
    • Barts & London School of Med
  • Manchester, United Kingdom, M2O 4BX
    • Christie Hospital Nhs Trust
• 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
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • 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
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Oncology - Central South
  • 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	PFS was defined as the time from randomization to the first occurrence to PD, as determined by the IRF per RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm). Data for participants who did not experience PD or death was censored at the last tumor assessment date. Data for participants with no post-baseline tumor assessments was censored at the randomization date. PFS was estimated using Kaplan-Meier (KM) method.	From randomization to the first occurrence of PD according to RECIST v1.1, or death from any cause, whichever occurred first (up to 2 years 5 months)
Overall Survival (OS)	OS was defined as the time from randomization to death due to any cause. Data for participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants without post-baseline information were censored at the date of randomization. OS was estimated using KM method.	From randomization to death due to any cause (up to 2 years 5 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS Assessed by the Investigators (INV-PFS), According to RECIST v1.1	PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Data for participants who did not experience PD or death was censored at the last tumor assessment date. Data for participants with no post-baseline tumor assessments were censored at the randomization date. PFS was estimated using KM method.	From randomization to the first occurrence of PD according to RECIST v1.1, or death from any cause, whichever occurred first (up to 2 years 5 months)
Investigator-assessed Objective Response Rate (ORR) (INV-ORR), According to RECIST v1.1	ORR was defined as the percentage of participants with an objective response i.e. a complete response (CR) or partial response (PR) at two consecutive tumor assessments at least 28 days apart, as determined by the investigator per RECIST v1.1. CR was defined as the disappearance of all target lesions, and any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.	Up to 2 years 5 months
IRF-assessed ORR (IRF-ORR) According to RECIST v1.1	ORR was defined as the percentage of participants with an objective response i.e. a CR or PR at two consecutive tumor assessments at least 28 days apart, as determined by the IRF per RECIST v1.1. CR was defined as the disappearance of all target lesions, and any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.	Up to 2 years 5 months
Investigator-assessed Duration of Response (DOR) (INV-DOR), According to RECIST v1.1	DOR was defined as the time from the first occurrence of an objective response (CR or PR) to PD or death, whichever occurred first, as determined by the investigator per RECIST v1.1. CR was defined as the disappearance of all target lesions, and any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. DOR was estimated using KM method.	From the date of first occurrence of a documented objective response to PD or death from any cause, whichever occurred first (up to 2 years 5 months)
IRF-assessed DOR (IRF-DOR) According to RECIST v1.1	DOR was defined as the time from the first occurrence of an objective response (CR or PR) to PD or death, whichever occurred first, as determined by IRF per RECIST v1.1. CR was defined as the disappearance of all target lesions, and any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. DOR was estimated using KM method.	From the date of first occurrence of a documented objective response to PD or death from any cause, whichever occurred first (up to 2 years 5 months)
Number of Participants With Adverse Events (AEs)	An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	Up to approximately 50 months
Serum Concentration of Atezolizumab		Predose on Day 1 of Cycles 1, 2, 3, 4, 8, 12 and 16; 30 minutes postdose on Cycle 1 Day 1 (1 cycle = 21 days); Treatment discontinuation visit (up to approximately 46 months)
Plasma Concentration of Cabozantinib		Predose on Day 1 of Cycles 2, 3, and 4 (1 cycle = 21 days); Treatment discontinuation visit (up to approximately 48 months)
Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab	Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response).	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Exelixis; Chugai Pharmaceutical
• 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.
• Pal SK, Albiges L, Tomczak P, Suarez C, Voss MH, de Velasco G, Chahoud J, Mochalova A, Procopio G, Mahammedi H, Zengerling F, Kim C, Osawa T, Angel M, Gupta S, Khan O, Bergthold G, Liu B, Kalaitzidou M, Huseni M, Scheffold C, Powles T, Choueiri TK. Atezolizumab plus cabozantinib versus cabozantinib monotherapy for patients with renal cell carcinoma after progression with previous immune checkpoint inhibitor treatment (CONTACT-03): a multicentre, randomised, open-label, phase 3 trial. Lancet. 2023 Jul 15;402(10397):185-195. doi: 10.1016/S0140-6736(23)00922-4. Epub 2023 Jun 5.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): March 24, 2025

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 19, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

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