A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors

Last updated: April 4, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Treatment

Tiragolumab and Atezolizumab IV FDC

Clinical Study ID

NCT05661578
GO44096
2023-508489-14-00
2022-001157-23
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the safety, pharmacokinetics, and immunogenicity of tiragolumab and atezolizumab intravenous fixed-dose combination (IV FDC) in participants with histologically confirmed PD-L1-selected solid tumors whose disease is locally advanced, recurrent, or metastatic and for whom an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

  • Life expectancy >=12 weeks

  • Adequate hematologic and end organ function

  • Recovery (i.e., improvement to Grade 1 or better) from all acute toxicities fromprevious therapy, excluding alopecia

  • For female participants of childbearing potential, negative serum pregnancy testwithin 14 days prior to initiation of study treatment (Day 1 of Cycle 1)

  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrainfrom donating eggs during the treatment period and for 5 months after the final doseof tiragolumab and atezolizumab IV FDC

  • For male participants: agreement to remain abstinent (refrain from heterosexualintercourse) or use a condom, and agree to refrain from donating sperm during thetreatment period and for 90 days after the final dose of tiragolumab andatezolizumab IV FDC to avoid exposing the embryo

Cancer-Specific Inclusion Criteria:

  • Histologic documentation of locally advanced, recurrent, or metastatic malignancy,ineligible for definitive local therapy, for which a clinical trial of aninvestigational agent in combination with an anti-PD-L1 antibody is considered anacceptable treatment option. Participant must be informed of all standard of careoptions available for his/her cancer.

  • No prior treatment with checkpoint inhibitor therapies (CPI-Naive)

  • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

  • Submittal of archival tumor and/or fresh tumor tissue to the central laboratory forprogrammed death-1 (PD-L1) evaluation prior to enrollment

  • PD-L1 selected tumors, as determined by the investigational VENTANA PD-L1 (SP263)immunohistochemistry (IHC) assay

Exclusion

Exclusion Criteria:

  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study orwithin 5 months after the final dose of tiragolumab and atezolizumab IV FDC

  • Significant cardiovascular disease

  • Known clinically significant liver disease

  • Poorly controlled Type 2 diabetes mellitus

  • Major surgical procedure within 28 days prior to Day 1 of Cycle 1 or anticipation ofneed for a major surgical procedure during the study

  • Any other diseases, metabolic dysfunction, physical examination finding, and/orclinical laboratory finding giving reasonable suspicion of a disease or conditionthat contraindicates the use of an investigational drug or that may affect theinterpretation of the results or may render the participant at high risk fromtreatment complications

  • History of autoimmune disease

  • Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1of Cycle 1

  • History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, orevidence of active pneumonitis on screening chest computed tomography (CT) scan

  • Severe infections within 4 weeks prior to Day 1 of Cycle 1 or recent infections/oralor IV antibiotics within 2 weeks prior to Day 1 of Cycle 1

Cancer-Specific Exclusion Criteria:

  • Any anti-cancer therapy, whether investigational or approved within 3 weeks prior toinitiation of study treatment

  • Prior treatment with immune checkpoint inhibitors (CPIs)

  • Less than 5 drug-elimination half-lives (~100 days for typical monoclonal antibody [Mab]) from the last dose of monoclonal antibodies (MAbs), and MAb-Derived Therapies (excluding CPIs) and the proposed Day 1 of Cycle 1

  • Less than 6 weeks between the last dose of prior immunomodulators and the proposedDay 1 of Cycle 1

  • Less than 6 weeks or 5-drug-elimination half-lives, whichever is shorter, of priortreatment with cancer vaccines and/or cytokines have elapsed between the last doseand the proposed Cycle 1, Day 1

  • Any history of an immune-mediated Grade 4 adverse event attributed to prior cancerimmunotherapy

  • Any history of an immune-mediated Grade 3 adverse event attributed to prior cancerimmunotherapy that resulted in permanent discontinuation of the priorimmunotherapeutic agent and/or occurred </=6 months prior to Day 1 of Cycle 1

  • Any immune-mediated adverse events related to prior cancer immunotherapy must haveresolved completely to baseline

  • Adverse events from prior anti-cancer therapy that have not resolved to Grade <=1except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Tiragolumab and Atezolizumab IV FDC
Phase: 2
Study Start date:
May 04, 2023
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 1Z5
    Canada

    Site Not Available

  • Sir Mortimer B Davis Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Chongqing Sanxia Central Hospital

    Chongqing City, 404000
    China

    Active - Recruiting

  • Tianjin Cancer Hospital

    Tianjin, 300060
    China

    Active - Recruiting

  • General Hospital Pula

    Pula, 52000
    Croatia

    Completed

  • Klinicki bolnicki centar Zagreb

    Zagreb, 10000
    Croatia

    Site Not Available

  • German Oncology Center

    Lemesos, 3096
    Cyprus

    Site Not Available

  • Bank Of Cyprus Oncology Centre

    Strovolos, 2006
    Cyprus

    Site Not Available

  • Cancer Research Centre

    Tbilisi, 0159
    Georgia

    Site Not Available

  • LLC Todua Clinic

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Ltd Israel-Georgia Medical Research Clinic Helsicore

    Tbilisi, 0112
    Georgia

    Site Not Available

  • University of Athens Medical School - Regional General Hospital Alexandra

    Athens, 115 28
    Greece

    Site Not Available

  • University of Athens, Hematological Clinic,

    Athens, 115 28
    Greece

    Site Not Available

  • University of Athens, Hematological Clinic,; First Department of Propaedeutic Medicine

    Athens, 115 28
    Greece

    Site Not Available

  • IASO Obstetrics Gynecology Clinic

    Marousi, 151 23
    Greece

    Completed

  • Agios Loucas Clinic SA

    Panorama, 552 36
    Greece

    Site Not Available

  • University General Hospital of Patras

    Patras, 265 00
    Greece

    Site Not Available

  • Euromedica PPDS

    Thessaloniki, 546 45
    Greece

    Site Not Available

  • Interbalkan Medical Center of Thessaloniki

    Thessaloniki, 546 39
    Greece

    Site Not Available

  • National Cancer Center

    Goyang-si, 10408
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605
    Korea, Republic of

    Site Not Available

  • Asan Medical Center - PPDS

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Centro de Investigación en Artritis y Osteoporosis - PPDS

    Mexicali, BAJA California 21200
    Mexico

    Site Not Available

  • Health Pharma Professional Research

    Cdmx, Mexico CITY (federal District) 03100
    Mexico

    Site Not Available

  • Institute for Oncology and Radiology of Serbia

    Belgrade, 11000
    Serbia

    Site Not Available

  • Oncomed-System

    Belgrade, 11000
    Serbia

    Site Not Available

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 11080
    Serbia

    Site Not Available

  • Health Center Kladovo

    Kladovo, 19320
    Serbia

    Site Not Available

  • Institute of Lung Diseases Vojvodina

    Sremska Kamenica, 21204
    Serbia

    Site Not Available

  • Oncology Institute of Vojvodina

    Sremska Kamenica, 21204
    Serbia

    Site Not Available

  • ICO l?Hospitalet ? Hospital Duran i Reynals

    L?Hospitalet De Llobregat, Barcelona 08908
    Spain

    Completed

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla 41071
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • C.H. Regional Reina Sofia - PPDS

    Cordoba, 14004
    Spain

    Site Not Available

  • START MADRID_Hospital Universiario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

    Madrid, 28050
    Spain

    Completed

  • Hospital Regional Universitario de Malaga ? Hospital General

    Malaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Completed

  • National Cheng Kung University Hospital

    Tainan, 70457
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Completed

  • TAIPEI VETERANS GENERAL HOSPITAL, Urology

    Taipei, 11217
    Taiwan

    Site Not Available

  • Adana Sehir Egitim ve Arastirma Hastanesi

    Adana, 1370
    Turkey

    Site Not Available

  • Namik Kemal University

    Alt?nova, 59100
    Turkey

    Site Not Available

  • Ankara Bilkent City Hospital

    Ankara, 06490
    Turkey

    Site Not Available

  • Gazi University Medical Faculty

    Ankara, 06500
    Turkey

    Site Not Available

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100
    Turkey

    Site Not Available

  • Memorial Ankara Hastanesi

    Ankara, 06520
    Turkey

    Site Not Available

  • Memorial Sisli Private Hospital

    Istanbul, 34385
    Turkey

    Site Not Available

  • Memorial Sisli Private Hospital; Urology

    Istanbul, 34385
    Turkey

    Site Not Available

  • T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Istanbul, 34722
    Turkey

    Site Not Available

  • Inonu University Faculty of Medicine Turgut Ozal Medical Center

    Malatya, 44280
    Turkey

    Site Not Available

  • Medical Park Seyhan Hospital

    Seyhan, 01060
    Turkey

    Site Not Available

  • Pikeville Medical Center

    Pikeville, Kentucky 41501
    United States

    Site Not Available

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • The Center for Cancer and Blood Disorders - PPDS

    Fort Worth, Texas 76104-4611
    United States

    Site Not Available

  • Medical Oncology Associates

    Spokane, Washington 99208
    United States

    Site Not Available

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