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

NCT ID: NCT05661578

Last Updated: 2026-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-04
• Study Completion Date: 2025-12-26

Brief 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.

Conditions

PD-L1-selected Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tiragolumab and Atezolizumab IV FDC

Participants will receive tiragolumab and atezolizumab as an intravenous fixed dose combination (IV FDC) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.

Group Type: EXPERIMENTAL

Tiragolumab and Atezolizumab IV FDC

Intervention Type: DRUG

Intravenous fixed dose combination (IV FDC) of tiragolumab 600 mg and atezolizumab 1200 mg once every 3 weeks (Q3W).

Interventions

Tiragolumab and Atezolizumab IV FDC

Intravenous fixed dose combination (IV FDC) of tiragolumab 600 mg and atezolizumab 1200 mg once every 3 weeks (Q3W).

Intervention Type: DRUG

Eligibility Criteria

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 from previous therapy, excluding alopecia
• For female participants of childbearing potential, negative serum pregnancy test within 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 refrain from donating eggs during the treatment period and for 5 months after the final dose of tiragolumab and atezolizumab IV FDC
• For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab and atezolizumab IV FDC to avoid exposing the embryo

• Histologic documentation of locally advanced, recurrent, or metastatic malignancy, ineligible for definitive local therapy, for which a clinical trial of an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option. Participant must be informed of all standard of care options 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 for programmed 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 Criteria

• Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 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 of need for a major surgical procedure during the study
• Any other diseases, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or may render the participant at high risk from treatment complications
• History of autoimmune disease
• Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
• History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence 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/oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1

• Any anti-cancer therapy, whether investigational or approved within 3 weeks prior to initiation 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 proposed Day 1 of Cycle 1
• Less than 6 weeks or 5-drug-elimination half-lives, whichever is shorter, of prior treatment with cancer vaccines and/or cytokines have elapsed between the last dose and the proposed Cycle 1, Day 1
• Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy
• Any history of an immune-mediated Grade 3 adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of the prior immunotherapeutic agent and/or occurred </=6 months prior to Day 1 of Cycle 1
• Any immune-mediated adverse events related to prior cancer immunotherapy must have resolved completely to baseline
• Adverse events from prior anti-cancer therapy that have not resolved to Grade <=1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Medical Oncology Associates

Spokane, Washington, United States

Chongqing Sanxia Central Hospital

Chongqing, , China

General Hospital Pula

Pula, , Croatia

Klinicki bolnicki centar Zagreb

Zagreb, , Croatia

IASO Obstetrics Gynecology Clinic

Marousi, , Greece

University General Hospital of Patras

Pátrai, , Greece

St. Luke's Hospital

Thessaloniki, , Greece

Oncomed-System

Belgrade, , Serbia

University Hospital Medical Center Bezanijska kosa

Belgrade, , Serbia

Oncology Institute of Vojvodina

Kamenitz, , Serbia

National Cancer Center

Goyang-si, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Asan Medical Center - PPDS

Seoul, , South Korea

ICO l?Hospitalet ? Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital del Mar

Barcelona, , Spain

Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

Barcelona, , Spain

C.H. Regional Reina Sofia - PPDS

Córdoba, , Spain

START MADRID_Hospital Universiario Fundacion Jimenez Diaz

Madrid, , Spain

START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

Madrid, , Spain

Hospital Regional Universitario de Malaga ? Hospital General

Málaga, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

China Medical University Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

TAIPEI VETERANS GENERAL HOSPITAL, Urology

Taipei, , Taiwan

Namik Kemal University

Alt?nova, , Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, , Turkey (Türkiye)

Gazi University Medical Faculty

Ankara, , Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, , Turkey (Türkiye)

Memorial Sisli Private Hospital

Istanbul, , Turkey (Türkiye)

Inonu University Faculty of Medicine Turgut Ozal Medical Center

Malatya, , Turkey (Türkiye)

Medical Park Seyhan Hospital

Seyhan, , Turkey (Türkiye)

Countries

United States; China; Croatia; Greece; Serbia; South Korea; Spain; Taiwan; Turkey (Türkiye)

Other Identifiers

2022-001157-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-508489-14-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

GO44096

Identifier Type: -

Identifier Source: org_study_id