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

April 10, 2024 updated by: Hoffmann-La Roche

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 efficacy, safety, and pharmacokinetics of tobemstomig (also known as 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Recruiting
        • Sunshine Coast University Hospital; The Adem Crosby Centre
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Recruiting
        • ICON Cancer Care Adelaide
  • China
      • Beijing, China, 100142
        • Active, not recruiting
        • Beijing Cancer Hospital
      • Beijing City, China, 100034
        • Active, not recruiting
        • Peking University First Hospital
      • Nanjing City, China, 210008
        • Active, not recruiting
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
      • Tianjin, China, 300060
        • Active, not recruiting
        • Tianjin Cancer Hospital
      • Xi'an, China, 710061
        • Recruiting
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • France
      • Avignon, France, 84918
        • Recruiting
        • Institut Sainte Catherine;Recherche Clinique
      • Besançon Cedex, France, 25030
        • Recruiting
        • CHU Besançon - Hôpital Jean Minjoz
      • Bordeaux, France, 33075
        • Recruiting
        • CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
      • Caen, France, 14076
        • Recruiting
        • Centre Francois Baclesse; Oncologie
      • Lyon, France, 69373
        • Recruiting
        • Centre Leon Berard; Departement Oncologie Medicale
      • Villejuif, France, 94800
        • Recruiting
        • Institut Gustave Roussy; Oncologie Medicale
  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
      • München, Germany, 81675
        • Recruiting
        • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
      • Nürtingen, Germany, 72622
        • Recruiting
        • Studienpraxis Urologie
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen; Klinik für Urologie
      • Ulm, Germany, 89081
        • Recruiting
        • Universitätsklinikum Ulm; Klinik für Urologie
  • Korea, Republic of
      • Goyang-si, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center
      • Jeollanam-do, Korea, Republic of, 58128
        • Active, not recruiting
        • Chonnam National University Hwasun Hospital
      • Seoul, Korea, Republic of, 03722
        • Active, not recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Active, not recruiting
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
  • Poland
      • Brzozów, Poland, 36-200
        • Completed
        • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
      • Bydgoszcz, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
      • Kraków, Poland, 30-688
        • Active, not recruiting
        • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
      • Lublin, Poland, 20-090
        • Recruiting
        • Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
      • Pozna?, Poland, 60-569
        • Active, not recruiting
        • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
      • Warszawa, Poland, 04-073
        • Recruiting
        • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
  • Spain
      • Barcelona, Spain, 08035
        • Active, not recruiting
        • Hospital Universitari Vall d'Hebron; Oncology
      • Madrid, Spain, 28041
        • Active, not recruiting
        • Hospital Universitario 12 de Octubre; Servicio de Oncologia
      • Madrid, Spain, 28034
        • Active, not recruiting
        • Hospital Universitario Ramon y Cajal;Oncology Dept.
      • Madrid, Spain, 28040
        • Active, not recruiting
        • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
      • Sevilla, Spain, 41013
        • Active, not recruiting
        • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
      • Valencia, Spain, 46026
        • Active, not recruiting
        • Hospital Universitari i Politecnic La Fe; Oncologia
  • United Kingdom
      • Burnley, United Kingdom, BB10 2PQ
        • Withdrawn
        • East Lancashire Hospitals NHS Trust
      • Colchester, Essex, United Kingdom, CO4 5JL
        • Withdrawn
        • Colchester General Hospital
      • Gillingham, United Kingdom, ME7 5NY
        • Withdrawn
        • Medway Maritime Hospital
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • Barts & London School of Med; Medical Oncology
      • London, United Kingdom, SW3 6JJ
        • Withdrawn
        • Royal Marsden Hospital; Dept of Med-Onc
      • Manchester, United Kingdom, M2O 4BX
        • Recruiting
        • Christie Hospital Nhs Trust; Medical Oncology
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham City Hospital; Oncology
      • Plymouth, United Kingdom, PL6 8DH
        • Withdrawn
        • Plymouth Oncology Centre; Clinical Trials Unit
      • Sutton, United Kingdom, SM2 5PT
        • Withdrawn
        • Royal Marsden Hospital; Institute of Cancer Research
      • Swansea, United Kingdom, SA2 8QA
        • Withdrawn
        • Singleton Hospital; Cancer Institute
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • Recruiting
        • University of Alabama at Birmingham; Comprehensive Cancer Center
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Recruiting
        • Sibley Memorial Hospital
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists - Fort Myers (Broadway)
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • Greco-Hainesworth Centers for Research; ETN (East Tennessee)
      • Knoxville, Tennessee, United States, 37916-2305
        • Recruiting
        • Thompson Cancer Survival Center
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology - Nashville
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center; Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Axitinib
Participants will receive axitinib PO BID.
Other Names:
  • Inlyta
Drug: Pembrolizumab
Participants will receive IV pembrolizumab Q3W.
Other Names:
  • Keytruda
Experimental: 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).
Drug: Axitinib
Participants will receive axitinib PO BID.
Other Names:
  • Inlyta
Drug: Tobemstomig
Participants will receive IV tobemstomig Q3W.
Other Names:
  • RO7247669
Experimental: 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.
Drug: Axitinib
Participants will receive axitinib PO BID.
Other Names:
  • Inlyta
Drug: Tiragolumab
Participants will receive IV tiragolumab Q3W.
Drug: Tobemstomig
Participants will receive IV tobemstomig Q3W.
Other Names:
  • RO7247669

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS)
Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 35 treatment cycles; cycle length = 21 days)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 35 treatment cycles; cycle length = 21 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From randomization to death from any cause (up to 35 treatment cycles; cycle length = 21 days)
From randomization to death from any cause (up to 35 treatment cycles; cycle length = 21 days)
Confirmed Objective Response Rate (ORR)
Time Frame: Up to 35 treatment cycles (cycle length = 21 days)
Up to 35 treatment cycles (cycle length = 21 days)
Duration of Response (DoR)
Time Frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 35 treatment cycles; cycle length = 21 days)
From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 35 treatment cycles; cycle length = 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-LaRoche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO43936

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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