AzTrials
AzTrials

Carcinoma, Renal CellPhase 3CONTACT-03NCT04338269

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

A Phase 3 study testing Atezolizumab and Cabozantinib in people with Carcinoma, Renal Cell, run by Hoffmann-La Roche at 135 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Atezolizumab and Cabozantinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
522 participants
Where
135 sitesin 15 countries
Study dates
28 Jul 2020to 24 Mar 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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)

Trial locations and contacts

135 sites in 15 countries.

135 sites in 15 countries

United States24 sites

  • New York Oncology Hematology,P.C.-Albany

    Albany, New York, 12208

  • University of Colorado

    Aurora, Colorado, 80045

  • Texas Oncology - Central South

    Austin, Texas, 78731

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Virginia Cancer Specialists - Gainsville

    Gainesville, Virginia, 20155

  • UC San Diego Health System

    La Jolla, California, 92093

  • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

    Las Vegas, Nevada, 89169

  • Rocky Mountain Cancer Center - Denver

    Littleton, Colorado, 80120

  • UCLA

    Los Angeles, California, 90095

  • Memorial Sloan Kettering - Monmouth

    Middletown, New Jersey, 07748

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Woodlands Medical Specialists, P.A.

    Pensacola, Florida, 32503

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University Of Utah

    Salt Lake City, Utah, 84108

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • University of Arizona

    Tucson, Arizona, 85724-5030

Other trials in United States

Spain21 sites

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario de Burgos

    Burgos, 09006

  • Hospital San Pedro De Alcantara

    Cáceres, 10003

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba, 14004

  • Hospital Lucus Augusti

    Lugo, 27003

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Virgen de Arrixaca

    Murcia, 30120

  • Hospital de Navarra

    Navarra, Navarre, 31008

  • Hospital Univ. Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07014

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario la Fe

    Valencia, 46026

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36213

Other trials in Spain

Italy13 sites

  • A.O. Universitaria Ospedale Consorziale Policlinico Di Bari

    Bari, Apulia, 70124

  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138

  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy, 25123

  • Fondazione del Piemonte per l?Oncologia (IRCCS)

    Candiolo (TO), Piedmont, 10060

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna, 47014

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133

  • Istituto Tumori Napoli

    Naples, Campania, 80131

  • Fondazione Salvatore Maugeri

    Pavia, Lombardy, 27100

  • Ospedale Di Macerata

    Province of Macerata, The Marches, 62100

  • Policlinico Universitario "Agostino Gemelli"

    Rome, Lazio, 00168

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

  • Azienda Ospedaliera S. Maria - Terni

    Terni, Umbria, 05100

  • A.O.U di Verona Policlinico G.B. Rossi

    Verona, Veneto, 37134

Other trials in Italy

France10 sites

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

    Bordeaux, 33075

  • Centre Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Oscar Lambret

    Lille, 59000

  • Centre Leon Berard

    Lyon, 69373

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital Europeen Georges Pompidou

    Paris, 75908

  • ICANS

    Strasbourg, 67200

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

Germany10 sites

  • Zeisigwaldkliniken Bethanien

    Chemnitz, 09130

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, 60590

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

    Halle, 06120

  • Uniklinik-Eppendorf

    Hamburg, 20246

  • Med. Hochschule Hannover, Hämatologie, Hämostaseologie, Onkologie u. Stammzelltransplantation

    Hanover, 30625

  • Klinikum rechts der Isar der TU München

    München, 81675

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Russia10 sites

  • Branch of the company "Hadassah Medical LTD"

    Innovatsionnogo Tsentra Skolkovo, Moscow Oblast, 121205

  • St-Petersburg Regional Oncology Dispensary

    Kuzmolovo, Leningrad, 188663

  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

    Moscow, Moscow Oblast, 115478

  • MEDSI Clinical Hospital on Pyatnitsky Highway

    Moscow, Moscow Oblast, 143422

  • SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

    Moskva, Moscow Oblast, 111123

  • National Medical Research Center for Surgery named after A.V. Vishnevsky

    Moskva, Moscow Oblast, 117997

  • Medical Center Avicenna

    Novosibirsk, 630099

  • Private Healthcare Institution Clinical Hospital RZhD Medicine

    Saint Petersburg, Sankt-Peterburg, 195271

  • AV Medical Ltd.

    Saint Petersburg, Sankt-Peterburg, 199034

  • Regional Clinical Oncology Hospital

    Yaroslavl, Yaroslavl Oblast, 150054

Other trials in Russia

Poland9 sites

  • Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

    ?ód?, 90-338

  • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

    Brzozów, 36-200

  • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

    Bydgoszcz, 85-796

  • SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4

    Bytom, 41-902

  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

    Otwock, 05-400

  • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu

    Późna, 60-569

  • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

    Warsaw, 04-073

  • Wojskowy Instytut Medyczny

    Warsaw, 04-141

  • Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii

    Wroc?aw, 53-413

Other trials in Poland

South Korea9 sites

  • Chungnam National University Hospital

    Daejeon, 35015

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Pusan National University Yangsan Hospital

    Gyeongsangnam-do, 50612

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Samsung Medical Center

    Seoul, 006351

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Japan8 sites

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • University of Tsukuba Hospital

    Ibaraki, 305-8576

  • Yokohama City University Hospital

    Kanagawa, 236-0004

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

  • Tokushima University Hospital

    Tokushima, 770-8503

  • Keio University Hospital

    Tokyo, 160-8582

  • Tokyo Women's Medical University Hospital

    Tokyo, 162-8666

Other trials in Japan

Greece5 sites

  • Alexandras General Hospital of Athens

    Athens, 115 28

  • Attikon University General Hospital

    Athens, 12464

  • Athens Medical Center

    Athens, 151 25

  • University Hospital of Larissa

    Larissa, 41110

  • Diavalkaniko Hospital

    Thessaloniki, 570 01

Other trials in Greece

United Kingdom5 sites

  • Royal Blackburn Hospital

    Blackburn, BB2 3HH

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Barts & London School of Med

    London, EC1A 7BE

  • Royal Marsden Hospital

    London, SW3 6JJ

  • Christie Hospital Nhs Trust

    Manchester, M2O 4BX

Other trials in United Kingdom

Argentina4 sites

  • Fundación CENIT para la Investigación en Neurociencias

    Buenos Aires, C1125ABD

  • Inst. Alexander Fleming

    Buenos Aires, C1426ANZ

  • Hospital Britanico

    Ciudad Autonoma Bs As, C1280AEB

  • Centro Medico Austral OMI

    Ciudad Autonoma Buenos Aires, C1019ABS

Other trials in Argentina

Australia4 sites

  • Bendigo Cancer Centre

    Bendigo, Victoria, 3550

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2109

  • Orange Hospital

    Orange, New South Wales, 2800

  • Icon Cancer Foundation

    South Brisbane, Queensland, 4101

Other trials in Australia

Canada2 sites

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

Denmark1 site

  • Herlev Hospital

    Herlev, 2730

Other trials in Denmark

About this study

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

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.

Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • AtezolizumabDrug

    Also called 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.

  • CabozantinibDrug

    Also called Cabometyx

    Cabozantinib 60 mg (three 20-mg tablets) administered orally once daily.

Study groups in NCT04338269
Study groupRoleWhat they receive
Atezo+CaboExperimentalParticipants 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.
Receives: Drug: Atezolizumab; Drug: Cabozantinib
CabozantinibActive comparatorParticipants will receive cabozantinib every day.
Receives: Drug: Cabozantinib

What is being measured

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

  1. Progression Free Survival (PFS) as Assessed by 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.

    Measured: 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)

  2. 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.

    Measured: From randomization to death due to any cause (up to 2 years 5 months).

Secondary outcomes (9)

  1. 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.

    Measured: 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)

  2. 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.

    Measured: Up to 2 years 5 months

  3. 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.

    Measured: Up to 2 years 5 months

  4. 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.

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: Up to approximately 50 months

  7. Serum Concentration of Atezolizumab

    Measured: 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)

  8. Plasma Concentration of Cabozantinib

    Measured: Predose on Day 1 of Cycles 2, 3, and 4 (1 cycle = 21 days); Treatment discontinuation visit (up to approximately 48 months)

  9. 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).

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted8 Apr 2020
  2. Study start28 Jul 2020
  3. Primary completion3 Jan 2023
  4. Study completion24 Mar 2025

Why it stopped: As the study did not meet it's primary endpoint a decision was made to terminate the study.

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
522 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04338269
Sponsor's protocol ID
WO41994
Acronym
CONTACT-03
Status last verified
Feb 2026
First submitted
6 Apr 2020
Last updated
19 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 37290461

  • 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.

    PubMed 35304832

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab and Cabozantinib in people with Carcinoma, Renal Cell, run by Hoffmann-La Roche at 135 sites in 15 countries.

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

Who may be eligible to take part?

The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in United States, Spain, Italy, France, Germany and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Progression Free Survival (PFS) as Assessed by an Independent Review Facility (IRF) (IRF-PFS) According to RECIST v1.1 (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04338269, which also lists 2 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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