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

Running, not enrolling · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

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).

Key facts

Study ID

NCT05805501

Run by

Hoffmann-La Roche

People needed

199

Starts

2023-04-21

Expected to finish

2026-10-31

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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