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New immunotherapy cocktail aims to simplify cancer treatment

NCT ID NCT05661578

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a fixed-dose combination of two immunotherapy drugs, tiragolumab and atezolizumab, given together as a single infusion every three weeks. The trial enrolled 64 people with advanced solid tumors that express a protein called PD-L1. The main goal was to check the safety and how the drugs move through the body, not to measure how well they fight the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tiragolumab and atezolizumab (immunotherapy drugs given together as a fixed-dose combination)
What this could lead to
If successful, this could provide a more convenient way to deliver a promising immunotherapy combination for certain advanced solid tumors.
What could go wrong
This is a small, early-phase study focused on safety and drug levels, not on how well the treatment works. The combination may not prove effective or could cause significant side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

64 people

The number who actually took part.

Started

May 2023

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 Cancer-Specific Inclusion Criteria: * 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 Cancer-Specific Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PD-L1-selected solid tumors

Contacts and locations

Locations

  • Asan Medical Center - PPDS

    Seoul, 05505, South Korea

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, 14004, Spain

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chongqing Sanxia Central Hospital

    Chongqing, 404000, China

  • Gazi University Medical Faculty

    Ankara, 06500, Turkey (Türkiye)

  • General Hospital Pula

    Pula, 52000, Croatia

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100, Turkey (Türkiye)

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Regional Universitario de Malaga ? Hospital General

    Málaga, 29010, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • IASO Obstetrics Gynecology Clinic

    Marousi, 151 23, Greece

  • ICO l?Hospitalet ? Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Inonu University Faculty of Medicine Turgut Ozal Medical Center

    Malatya, 44280, Turkey (Türkiye)

  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

    Barcelona, 8035, Spain

  • Klinicki bolnicki centar Zagreb

    Zagreb, 10000, Croatia

  • Medical Oncology Associates

    Spokane, Washington, 99208, United States

  • Medical Park Seyhan Hospital

    Seyhan, 01060, Turkey (Türkiye)

  • Memorial Ankara Hastanesi

    Ankara, 06520, Turkey (Türkiye)

  • Memorial Sisli Private Hospital

    Istanbul, 34385, Turkey (Türkiye)

  • Namik Kemal University

    Alt?nova, 59100, Turkey (Türkiye)

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Cheng Kung University Hospital

    Tainan, 70457, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Oncology Institute of Vojvodina

    Kamenitz, 21204, Serbia

  • START MADRID_Hospital Universiario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

    Madrid, 28050, Spain

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605, South Korea

  • St. Luke's Hospital

    Thessaloniki, 552 36, Greece

  • TAIPEI VETERANS GENERAL HOSPITAL, Urology

    Taipei, 11217, Taiwan

  • University General Hospital of Patras

    Pátrai, 265 00, Greece

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 11080, Serbia

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