A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma
NCT ID: NCT05805501
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
199 participants
INTERVENTIONAL
2023-04-21
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (Tobemstomig + Axitinib)
Participants 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).
Tobemstomig
Participants will receive IV tobemstomig Q3W.
Axitinib
Participants will receive axitinib PO BID.
Arm B (Tobemstomig + Tiragolumab + Axitinib)
Participants will receive IV tobemstomig followed by IV tiragolumab Q3W on Day 1 of 21-day cycle. Participants will also receive axitinib PO BID.
Tobemstomig
Participants will receive IV tobemstomig Q3W.
Tiragolumab
Participants will receive IV tiragolumab Q3W.
Axitinib
Participants will receive axitinib PO BID.
Control Arm (Pembrolizumab + Axitinib)
Participants will receive IV pembrolizumab Q3W on Day 1 of each 21-day cycle. Participants will also receive axitinib PO BID.
Pembrolizumab
Participants will receive IV pembrolizumab Q3W.
Axitinib
Participants will receive axitinib PO BID.
Interventions
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Tobemstomig
Participants will receive IV tobemstomig Q3W.
Tiragolumab
Participants will receive IV tiragolumab Q3W.
Pembrolizumab
Participants will receive IV pembrolizumab Q3W.
Axitinib
Participants will receive axitinib PO BID.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-LaRoche
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
UC Irvine Medical Center
Orange, California, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Peking University First Hospital
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, , China
Tianjin Cancer Hospital
Tianjin, , China
Institut Sainte Catherine
Avignon, , France
CHU Besançon - Hôpital Jean Minjoz
Besançon, , France
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
Bordeaux, , France
Centre Francois Baclesse
Caen, , France
Centre Leon Berard
Lyon, , France
Institut Gustave Roussy
Villejuif, , France
Universitätsklinikum "Carl Gustav Carus"
Dresden, , Germany
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Klinikum rechts der Isar der TU München
München, , Germany
Studienpraxis Urologie
Nürtingen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
Brzozów, , Poland
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
Bydgoszcz, , Poland
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
Krakow, , Poland
Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu
Późna, , Poland
National Cancer Center
Goyang-si, , South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Reina Sofia
Córdoba, Cordoba, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Barts & London School of Med
London, , United Kingdom
Christie Hospital Nhs Trust
Manchester, , United Kingdom
Countries
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Other Identifiers
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BO43936
Identifier Type: -
Identifier Source: org_study_id