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New combo for kidney cancer shows promise but trial halted early

NCT ID NCT04338269

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tested whether adding atezolizumab (an immunotherapy) to cabozantinib (a targeted therapy) helps people with advanced kidney cancer whose disease worsened after prior immunotherapy. The trial enrolled 522 participants but was terminated early, so the full benefits and risks are not clear. The combination may still offer a treatment option, but more research is needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atezolizumab (Tecentriq) and cabozantinib (Cabometyx)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced kidney cancer that has progressed after immunotherapy.
What could go wrong
The trial was terminated early, so results are limited. It is unclear if the combination is better than cabozantinib alone, and side effects from both drugs can be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

522 people

The number who actually took part.

Started

Jul 2020

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

renal cell adenocarcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, renal cell

Contacts and locations

Locations

  • A.O. Universitaria Ospedale Consorziale Policlinico Di Bari

    Bari, Apulia, 70124, Italy

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

    Verona, Veneto, 37134, Italy

  • AV Medical Ltd.

    Saint Petersburg, Sankt-Peterburg, 199034, Russia

  • Alexandras General Hospital of Athens

    Athens, 115 28, Greece

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy, 25123, Italy

  • Athens Medical Center

    Athens, 151 25, Greece

  • Attikon University General Hospital

    Athens, 12464, Greece

  • Azienda Ospedaliera S. Maria - Terni

    Terni, Umbria, 05100, Italy

  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138, Italy

  • Barts & London School of Med

    London, EC1A 7BE, United Kingdom

  • Bendigo Cancer Centre

    Bendigo, Victoria, 3550, Australia

  • Branch of the company "Hadassah Medical LTD"

    Innovatsionnogo Tsentra Skolkovo, Moscow Oblast, 121205, Russia

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496, South Korea

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030, France

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

    Bordeaux, 33075, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Francois Baclesse

    Caen, 14076, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Centre Oscar Lambret

    Lille, 59000, France

  • Centro Medico Austral OMI

    Ciudad Autonoma Buenos Aires, C1019ABS, Argentina

  • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

    Bydgoszcz, 85-796, Poland

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

    ?ód?, 90-338, Poland

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Christie Hospital Nhs Trust

    Manchester, M2O 4BX, United Kingdom

  • Chungnam National University Hospital

    Daejeon, 35015, South Korea

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

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

    Las Vegas, Nevada, 89169, United States

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208, Spain

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Diavalkaniko Hospital

    Thessaloniki, 570 01, Greece

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

    Wroc?aw, 53-413, Poland

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

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

    Otwock, 05-400, Poland

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

    Moscow, Moscow Oblast, 115478, Russia

  • Fondazione Salvatore Maugeri

    Pavia, Lombardy, 27100, Italy

  • Fondazione del Piemonte per l?Oncologia (IRCCS)

    Candiolo (TO), Piedmont, 10060, Italy

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fundación CENIT para la Investigación en Neurociencias

    Buenos Aires, C1125ABD, Argentina

  • Herlev Hospital

    Herlev, 2730, Denmark

  • Hokkaido University Hospital

    Hokkaido, 060-8648, Japan

  • Hopital Europeen Georges Pompidou

    Paris, 75908, France

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36213, Spain

  • Hospital Britanico

    Ciudad Autonoma Bs As, C1280AEB, Argentina

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Lucus Augusti

    Lugo, 27003, Spain

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital San Pedro De Alcantara

    Cáceres, 10003, Spain

  • Hospital Univ. Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba, 14004, Spain

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07014, Spain

  • Hospital Universitario Virgen de Arrixaca

    Murcia, 30120, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Burgos

    Burgos, 09006, Spain

  • Hospital Universitario la Fe

    Valencia, 46026, Spain

  • Hospital de Navarra

    Navarra, Navarre, 31008, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • ICANS

    Strasbourg, 67200, France

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

    Meldola, Emilia-Romagna, 47014, Italy

  • Icon Cancer Foundation

    South Brisbane, Queensland, 4101, Australia

  • Inst. Alexander Fleming

    Buenos Aires, C1426ANZ, Argentina

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133, Italy

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089, Italy

  • Istituto Tumori Napoli

    Naples, Campania, 80131, Italy

  • Keio University Hospital

    Tokyo, 160-8582, Japan

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, 60590, Germany

  • Klinikum rechts der Isar der TU München

    München, 81675, Germany

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

    Halle, 06120, Germany

  • Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • MEDSI Clinical Hospital on Pyatnitsky Highway

    Moscow, Moscow Oblast, 143422, Russia

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2109, Australia

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

    Hanover, 30625, Germany

  • Medical Center Avicenna

    Novosibirsk, 630099, Russia

  • Memorial Sloan Kettering - Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Mount Sinai Medical Center

    New York, New York, 10029, United States

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

    Moskva, Moscow Oblast, 117997, Russia

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

    Albany, New York, 12208, United States

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Orange Hospital

    Orange, New South Wales, 2800, Australia

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586, Japan

  • Ospedale Di Macerata

    Province of Macerata, The Marches, 62100, Italy

  • Policlinico Universitario "Agostino Gemelli"

    Rome, Lazio, 00168, Italy

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1Z5, Canada

  • Private Healthcare Institution Clinical Hospital RZhD Medicine

    Saint Petersburg, Sankt-Peterburg, 195271, Russia

  • Pusan National University Yangsan Hospital

    Gyeongsangnam-do, 50612, South Korea

  • Regional Clinical Oncology Hospital

    Yaroslavl, Yaroslavl Oblast, 150054, Russia

  • Rocky Mountain Cancer Center - Denver

    Littleton, Colorado, 80120, United States

  • Royal Blackburn Hospital

    Blackburn, BB2 3HH, United Kingdom

  • Royal Marsden Hospital

    London, SW3 6JJ, United Kingdom

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

    Moskva, Moscow Oblast, 111123, Russia

  • SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4

    Bytom, 41-902, Poland

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Samsung Medical Center

    Seoul, 006351, South Korea

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • St-Petersburg Regional Oncology Dispensary

    Kuzmolovo, Leningrad, 188663, Russia

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6, Canada

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

    Warsaw, 04-073, Poland

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

    Późna, 60-569, Poland

  • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

    Brzozów, 36-200, Poland

  • Texas Oncology - Central South

    Austin, Texas, 78731, United States

  • Tokushima University Hospital

    Tokushima, 770-8503, Japan

  • Tokyo Women's Medical University Hospital

    Tokyo, 162-8666, Japan

  • UC San Diego Health System

    La Jolla, California, 92093, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • Uniklinik-Eppendorf

    Hamburg, 20246, Germany

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitaetsklinikum Muenster

    Münster, 48149, Germany

  • University Hospital of Larissa

    Larissa, 41110, Greece

  • University Of Utah

    Salt Lake City, Utah, 84108, United States

  • University of Arizona

    Tucson, Arizona, 85724-5030, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Tsukuba Hospital

    Ibaraki, 305-8576, Japan

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

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

    Barcelona, 08035, Spain

  • Virginia Cancer Specialists - Gainsville

    Gainesville, Virginia, 20155, United States

  • Wojskowy Instytut Medyczny

    Warsaw, 04-141, Poland

  • Woodlands Medical Specialists, P.A.

    Pensacola, Florida, 32503, United States

  • Yokohama City University Hospital

    Kanagawa, 236-0004, Japan

  • Zeisigwaldkliniken Bethanien

    Chemnitz, 09130, Germany

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