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New cocktail of drugs shows promise for tough kidney cancer

NCT ID NCT05805501

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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study tests whether combining newer immunotherapy drugs with a standard targeted therapy (axitinib) can safely control advanced kidney cancer. About 199 adults with untreated, advanced clear-cell renal cell carcinoma will receive one of three drug combinations. The main goal is to check for side effects and see how well the treatments work.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

199 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

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: * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 * International Metastatic RCC Database Consortium (IMDC) risk intermediate (score of 1 or 2) or poor (score of 3-6) * Measurable disease with at least one measurable lesion * Histologically confirmed ccRCC with or without sarcomatoid features * Negative for HIV, hepatitis B, or hepatitis C virus (HCV) Exclusion Criteria: * Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 90 days after the final dose of tiragolumab, 4 months after the final dose of tobemstomig (RO7249669) and pembrolizumab, or for 1 week after the final dose of axitinib, whichever occurs last * Inability to swallow a tablet or malabsorption syndrome * Prior treatment for localized and/or metastatic RCC with systemic RCC-directed therapy, including T-cell costimulating or immune checkpoint blockade therapies * Ongoing use or anticipated need for treatment with a strong CYP3A4/5 inhibitor or inducer * 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 * Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * History of leptomeningeal disease * Uncontrolled tumor-related pain * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) * Moderate to severe hepatic impairment (Child-Pugh B or C) * Uncontrolled hypertension * Prior history of hypertensive crisis or hypertensive encephalopathy * Significant cardiovascular/cerebrovascular disease within 3 months (12 months for UK participants) prior to randomization * History of clinically significant ventricular dysrhythmias or risk factors for ventricular dysrhythmias * History of congenital QT syndrome * Resting heart rate (HR) \> 100 bpm (or clinically significant tachycardia) * Stroke (including transient ischemic attack), myocardial infarction, or other symptomatic ischemic event, or thromboembolic event (e.g., deep venous thrombosis \[DVT\], pulmonary embolism \[PE\]) within 3 months (12 months for UK participants) before randomization * 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 * Tumors invading pulmonary blood vessels, cavitating pulmonary lesions or known endobronchial disease * Tumor invading the gastrointestinal (GI) tract, including abdominal or tracheoesophageal fistulas * Evidence of abdominal free air not explained by paracentesis or recent surgical procedure * Active peptic ulcer disease, acute pancreatitis, acute obstruction of the pancreatic or biliary duct, appendicitis, cholangitis, cholecystitis, diverticulitis, gastric outlet obstruction * Intra-abdominal abscess within 6 months before initiation of study treatment * Clinical signs or symptoms of GI obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding * Evidence of bleeding diathesis or significant coagulopathy * Grade ≥ 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment * Clinically significant hematuria, hematemesis, hemoptysis of \> 0.5 teaspoon (2.5 mL) of red blood, coagulopathy, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 3 months before initiation of study treatment * Active or history of autoimmune disease or immune deficiency * Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment * Prior allogeneic stem cell or solid organ transplantation * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * History of another primary malignancy other than RCC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%) * Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live, attenuated vaccine will be required during the study * Active tuberculosis (TB) * Severe infection within 4 weeks prior to initiation of study treatment * Participants with active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening * Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment * Known hypersensitivity to Chinese hamster \*ovary cell products or to any component of tobemstomig, tiragolumab, pembrolizumab, or axitinib

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Conditions

The condition(s) this trial relates to.

nonpapillary renal cell carcinoma renal cell carcinoma

As listed by the trial registrant

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

Renal cell carcinoma

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Barts & London School of Med

    London, EC1A 7BE, United Kingdom

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030, France

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

    Bordeaux, 33075, France

  • Centre Francois Baclesse

    Caen, 14076, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

    Bydgoszcz, 85-796, Poland

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Christie Hospital Nhs Trust

    Manchester, M2O 4BX, United Kingdom

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba, 14004, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025, Spain

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Institut Sainte Catherine

    Avignon, 84918, France

  • Klinikum rechts der Isar der TU München

    München, 81675, Germany

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210008, China

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • Peking University First Hospital

    Beijing, 100034, China

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • Studienpraxis Urologie

    Nürtingen, 72622, Germany

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575, Australia

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

    Późna, 60-569, Poland

  • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

    Brzozów, 36-200, Poland

  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

    Krakow, 31-501, Poland

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

  • UC Irvine Medical Center

    Orange, California, 92868, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-9179, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • Universitätsklinikum "Carl Gustav Carus"

    Dresden, 01307, Germany

  • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

    Hamburg, 20246, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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