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En undersøgelse af immun checkpoint-hæmmerkombinationer med axitinib hos deltagere med ubehandlet lokalt avanceret inoperabelt eller metastatisk nyrecellekarcinom

2. november 2026 opdateret af: Hoffmann-La Roche

Et randomiseret åbent fase II-studie af immun checkpoint-hæmmerkombinationer med axitinib hos patienter med tidligere ubehandlet lokalt avanceret ikke-operabelt eller metastatisk nyrecellekarcinom

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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

199

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • Queensland
      • Birtinya, Queensland, Australien, 4575
        • Sunshine Coast University Hospital
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, EC1A 7BE
        • Barts & London School of Med
      • Manchester, Det Forenede Kongerige, M2O 4BX
        • Christie Hospital Nhs Trust
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
    • California
      • Orange, California, Forenede Stater, 92868
        • UC Irvine Medical Center
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, Forenede Stater, 37203
        • SCRI Oncology Partners
    • Texas
      • Dallas, Texas, Forenede Stater, 75390-9179
        • UT Southwestern Medical Center
  • Frankrig
      • Avignon, Frankrig, 84918
        • Institut Sainte Catherine
      • Besançon, Frankrig, 25030
        • CHU Besançon - Hôpital Jean Minjoz
      • Bordeaux, Frankrig, 33075
        • CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
      • Caen, Frankrig, 14076
        • Centre Francois Baclesse
      • Lyon, Frankrig, 69373
        • Centre Leon Berard
      • Villejuif, Frankrig, 94800
        • Institut Gustave Roussy
  • Kina
      • Beijing, Kina, 100142
        • Beijing Cancer Hospital
      • Nanjing, Kina, 210008
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
      • Tianjin, Kina, 300060
        • Tianjin Cancer Hospital
  • Polen
      • Brzozów, Polen, 36-200
        • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
      • Bydgoszcz, Polen, 85-796
        • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
      • Krakow, Polen, 31-501
        • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
      • Późna, Polen, 60-569
        • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu
  • Spanien
      • Barcelona, Spanien, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spanien, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Madrid, Spanien, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spanien, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spanien, 28040
        • Hospital Universitario Clínico San Carlos
      • Seville, Spanien, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spanien, 46026
        • Hospital Universitari i Politecnic La Fe
    • Cordoba
      • Córdoba, Cordoba, Spanien, 14004
        • Hospital Universitario Reina Sofia
  • Sydkorea
      • Goyang-si, Sydkorea, 10408
        • National Cancer Center
      • Jeollanam-do, Sydkorea, 58128
        • Chonnam National University Hwasun Hospital
      • Seoul, Sydkorea, 05505
        • Asan Medical Center
      • Seoul, Sydkorea, 06351
        • Samsung Medical Center
      • Seoul, Sydkorea, 03722
        • Severance Hospital, Yonsei University Health System
  • Tyskland
      • Dresden, Tyskland, 01307
        • Universitätsklinikum "Carl Gustav Carus"
      • Hamburg, Tyskland, 20246
        • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
      • Hanover, Tyskland, 30625
        • Medizinische Hochschule Hannover
      • München, Tyskland, 81675
        • Klinikum rechts der Isar der TU München
      • Nürtingen, Tyskland, 72622
        • Studienpraxis Urologie
      • Ulm, Tyskland, 89081
        • Universitätsklinikum Ulm

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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 (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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Medicin: Tobemstomig

Participants will receive IV tobemstomig Q3W.

Andre navne:
  • RO7247669
Medicin: Axitinib

Participants will receive axitinib PO BID.

Andre navne:
  • Inlyta
Eksperimentel: 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.
Medicin: Tobemstomig

Participants will receive IV tobemstomig Q3W.

Andre navne:
  • RO7247669
Medicin: Axitinib

Participants will receive axitinib PO BID.

Andre navne:
  • Inlyta
Medicin: Tiragolumab

Participants will receive IV tiragolumab Q3W.
Aktiv komparator: 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.
Medicin: Axitinib

Participants will receive axitinib PO BID.

Andre navne:
  • Inlyta
Medicin: Pembrolizumab

Participants will receive IV pembrolizumab Q3W.

Andre navne:
  • Keytruda

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Forekomst og sværhedsgrad af bivirkninger (AES)
Tidsramme: Op til maksimalt 2 år
Op til maksimalt 2 år

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Efterforskere

  • Studieleder: Clinical Trials, Hoffmann-LaRoche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. april 2023

Primær færdiggørelse (Faktiske)

5. oktober 2026

Studieafslutning (Faktiske)

5. oktober 2026

Datoer for studieregistrering

Først indsendt

28. marts 2023

Først indsendt, der opfyldte QC-kriterier

28. marts 2023

Først opslået (Faktiske)

10. april 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BO43936

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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