Kidney Cancer Clinical Trial

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

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of RO7247669 (PD1-LAG3) 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).

View Eligibility Criteria

Eligibility Criteria

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 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 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

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

210

Study ID:

NCT05805501

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 61 Locations for this study

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University of Alabama at Birmingham; Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
UC Irvine Medical Center
Orange California, 92868, United States
University of Colorado
Aurora Colorado, 80045, United States
Sibley Memorial Hospital
Washington District of Columbia, 20016, United States
Florida Cancer Specialists - Fort Myers (Broadway)
Fort Myers Florida, 33901, United States
EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center
Atlanta Georgia, 30322, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building
Baltimore Maryland, 21287, United States
Greco-Hainesworth Centers for Research; ETN (East Tennessee)
Chattanooga Tennessee, 37404, United States
Thompson Cancer Survival Center
Knoxville Tennessee, 37916, United States
Tennessee Oncology - Nashville
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center; Vanderbilt University
Nashville Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
Sunshine Coast University Hospital; The Adem Crosby Centre
Birtinya Queensland, 4575, Australia
ICON Cancer Care Adelaide
Kurralta Park South Australia, 5037, Australia
Peking University First Hospital
Beijing City , 10003, China
Beijing Cancer Hospital
Beijing , 10014, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing City , 21000, China
Tianjin Cancer Hospital
Tianjin , 30006, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an , 71006, China
Institut Sainte Catherine;Recherche Clinique
Avignon , 84918, France
CHU Besançon - Hôpital Jean Minjoz
Besançon Cedex , 25030, France
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
Bordeaux , 33075, France
Centre Francois Baclesse; Oncologie
Caen , 14076, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon , 69373, France
Institut Gustave Roussy; Oncologie Medicale
Villejuif , 94800, France
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
Dresden , 01307, Germany
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Hamburg , 20246, Germany
Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
Hannover , 30625, Germany
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
München , 81675, Germany
Studienpraxis Urologie
Nürtingen , 72622, Germany
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen , 72076, Germany
Universitätsklinikum Ulm; Klinik für Urologie
Ulm , 89081, Germany
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
Brzozów , 36-20, Poland
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
Bydgoszcz , 85-79, Poland
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
Kraków , 30-68, Poland
Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
Lublin , 20-09, Poland
Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
Pozna? , 60-56, Poland
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
Warszawa , 04-07, Poland
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba Cordoba, 14004, Spain
Hospital Universitari Vall d'Hebron; Oncology
Barcelona , 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 8041, Spain
Hospital Universitario Ramon y Cajal;Oncology Dept.
Madrid , 28034, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Hospital Universitari i Politecnic La Fe; Oncologia
Valencia , 46026, Spain
East Lancashire Hospitals NHS Trust
Burnley , BB10 , United Kingdom
Colchester General Hospital
Colchester, Essex , CO4 5, United Kingdom
Medway Maritime Hospital
Gillingham , ME7 5, United Kingdom
Barts & London School of Med; Medical Oncology
London , EC1A , United Kingdom
Royal Marsden Hospital; Dept of Med-Onc
London , SW3 6, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester , M2O 4, United Kingdom
Nottingham City Hospital; Oncology
Nottingham , NG5 1, United Kingdom
Plymouth Oncology Centre; Clinical Trials Unit
Plymouth , PL6 8, United Kingdom
Royal Marsden Hospital; Institute of Cancer Research
Sutton , SM2 5, United Kingdom
Singleton Hospital; Cancer Institute
Swansea , SA2 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

210

Study ID:

NCT05805501

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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