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

NCT05805501 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: BO43936
• Study Type: interventional
• Target: 199
• Locations: 9 countries
• Sites: 43

Brief 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).

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Adverse Events (AEs)

  Up to a maximum of 2 years

Study Arms (3)

Arm A (Tobemstomig + Axitinib)

EXPERIMENTAL

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).

Drug: Tobemstomig; Drug: Axitinib

Arm B (Tobemstomig + Tiragolumab + Axitinib)

EXPERIMENTAL

Participants will receive IV tobemstomig followed by IV tiragolumab Q3W on Day 1 of 21-day cycle. Participants will also receive axitinib PO BID.

Drug: Tobemstomig; Drug: Tiragolumab; Drug: Axitinib

Control Arm (Pembrolizumab + Axitinib)

ACTIVE COMPARATOR

Participants will receive IV pembrolizumab Q3W on Day 1 of each 21-day cycle. Participants will also receive axitinib PO BID.

Drug: Pembrolizumab; Drug: Axitinib

Interventions

Tobemstomig DRUG

Participants will receive IV tobemstomig Q3W.

Also known as: RO7247669

Arm A (Tobemstomig + Axitinib); Arm B (Tobemstomig + Tiragolumab + Axitinib)

Tiragolumab DRUG

Participants will receive IV tiragolumab Q3W.

Arm B (Tobemstomig + Tiragolumab + Axitinib)

Pembrolizumab DRUG

Participants will receive IV pembrolizumab Q3W.

Also known as: Keytruda

Control Arm (Pembrolizumab + Axitinib)

Axitinib DRUG

Participants will receive axitinib PO BID.

Also known as: Inlyta

Arm A (Tobemstomig + Axitinib); Arm B (Tobemstomig + Tiragolumab + Axitinib); Control Arm (Pembrolizumab + Axitinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (43)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

UC Irvine Medical Center

Orange, California, 92868, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-9179, United States

Location

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

Location

Peking University First Hospital

Beijing, 100034, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

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

Nanjing, 210008, China

Location

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

Institut Sainte Catherine

Avignon, 84918, France

Location

CHU Besançon - Hôpital Jean Minjoz

Besançon, 25030, France

Location

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

Bordeaux, 33075, France

Location

Centre Francois Baclesse

Caen, 14076, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Universitätsklinikum "Carl Gustav Carus"

Dresden, 01307, Germany

Location

Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Klinikum rechts der Isar der TU München

München, 81675, Germany

Location

Studienpraxis Urologie

Nürtingen, 72622, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

Brzozów, 36-200, Poland

Location

Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

Bydgoszcz, 85-796, Poland

Location

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

Krakow, 31-501, Poland

Location

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

Późna, 60-569, Poland

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Universitario Reina Sofia

Córdoba, Cordoba, 14004, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Barts & London School of Med

London, EC1A 7BE, United Kingdom

Location

Christie Hospital Nhs Trust

Manchester, M2O 4BX, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Tiragolumab; pembrolizumab; Axitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Clinical Trials

  Hoffmann-LaRoche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: April 21, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

PL (4); CN (4); AU (1); ES (8); US (8); GB (2); FR (6); DE (6); KR (4)