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Renal Cell CarcinomaPhase 2NCT05805501

A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

A Phase 2 study testing Tobemstomig, Tiragolumab and Pembrolizumab in people with Renal Cell Carcinoma, run by Hoffmann-La Roche at 42 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the safety of tobemstomig (RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and axitinib as compared to pembrolizumab and axitinib in participants with previously untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma (ccRCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Tobemstomig, Tiragolumab and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
199 participants
Where
42 sitesin 9 countries
Study dates
21 Apr 2023to 5 Oct 2026
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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)

Who cannot join

  • 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
Show all 39Show fewer
  • 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

Trial locations and contacts

42 sites in 9 countries.

42 sites in 9 countries

Spain8 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba, 14004

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

United States7 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-9179

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • UC Irvine Medical Center

    Orange, California, 92868

Other trials in United States

France6 sites

  • Institut Sainte Catherine

    Avignon, 84918

  • 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 Leon Berard

    Lyon, 69373

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

Germany6 sites

  • Universitätsklinikum "Carl Gustav Carus"

    Dresden, 01307

  • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Klinikum rechts der Isar der TU München

    München, 81675

  • Studienpraxis Urologie

    Nürtingen, 72622

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

South Korea5 sites

  • National Cancer Center

    Goyang-si, 10408

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Poland4 sites

  • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

    Brzozów, 36-200

  • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

    Bydgoszcz, 85-796

  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

    Krakow, 31-501

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

    Późna, 60-569

Other trials in Poland

China3 sites

  • Beijing Cancer Hospital

    Beijing, 100142

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

    Nanjing, 210008

  • Tianjin Cancer Hospital

    Tianjin, 300060

Other trials in China

United Kingdom2 sites

  • Barts & London School of Med

    London, EC1A 7BE

  • Christie Hospital Nhs Trust

    Manchester, M2O 4BX

Other trials in United Kingdom

Australia1 site

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

Other trials in Australia

About this study

Official title: A Randomized Open Label Phase II Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

This study will evaluate the safety of tobemstomig (RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and axitinib as compared to pembrolizumab and axitinib in participants with previously untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma (ccRCC).

Being tested
Tobemstomig, Tiragolumab, Pembrolizumab, Axitinib
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.

  • TobemstomigDrug

    Also called RO7247669

    Participants will receive IV tobemstomig Q3W.

  • TiragolumabDrug

    Participants will receive IV tiragolumab Q3W.

  • PembrolizumabDrug

    Also called Keytruda

    Participants will receive IV pembrolizumab Q3W.

  • AxitinibDrug

    Also called Inlyta

    Participants will receive axitinib PO BID.

Study groups in NCT05805501
Study groupRoleWhat they receive
Arm A (Tobemstomig + Axitinib)ExperimentalParticipants will receive intravenous (IV) tobemstomig every three weeks (Q3W) on Day 1 of each 21-day cycle. Participants will also receive oral (PO) axitinib twice daily (BID).
Receives: Drug: Tobemstomig; Drug: Axitinib
Arm B (Tobemstomig + Tiragolumab + Axitinib)ExperimentalParticipants will receive IV tobemstomig followed by IV tiragolumab Q3W on Day 1 of 21-day cycle. Participants will also receive axitinib PO BID.
Receives: Drug: Tobemstomig; Drug: Tiragolumab; Drug: Axitinib
Control Arm (Pembrolizumab + Axitinib)Active comparatorParticipants will receive IV pembrolizumab Q3W on Day 1 of each 21-day cycle. Participants will also receive axitinib PO BID.
Receives: Drug: Pembrolizumab; Drug: Axitinib

What is being measured

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

  1. Incidence and Severity of Adverse Events (AEs)

    Measured: Up to a maximum of 2 years

Timeline

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

  1. First posted10 Apr 2023
  2. Study start21 Apr 2023
  3. Primary completion5 Oct 2026
  4. Study completion5 Oct 2026

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05805501
Sponsor's protocol ID
BO43936
Status last verified
Nov 2026
First submitted
28 Mar 2023
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tobemstomig, Tiragolumab and Pembrolizumab in people with Renal Cell Carcinoma, run by Hoffmann-La Roche at 42 sites in 9 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 5 inclusion and 39 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: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Spain, United States, France, Germany, South Korea and 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence and Severity of Adverse Events (AEs) (time frame: Up to a maximum of 2 years). 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 NCT05805501.

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 3 Nov 2026.

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