A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

NCT04665843 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: BO425332020-002852-19
• Study Type: interventional
• Target: 123
• Locations: 13 countries
• Sites: 47

Brief Summary

The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Confirmed Objective Response, as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

  A confirmed objective response rate (ORR) was defined as the percentage of participants with a confirmed objective response (OR), characterized by a complete response (CR) or a partial response (PR), on 2 consecutive occasions ≥ 4 weeks apart, as determined by the investigator per RECIST v1.1. CR was defined as the disappearance of all target and non-target lesions \& normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.

  Up to approximately 30.6 months

Secondary Outcomes (11)

• Duration of Response (DOR)

  From first occurrence of a documented confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 30.6 months)

• Progression-free Survival (PFS)

  From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 30.6 months)

• Overall Survival (OS)

  From randomization to death from any cause (up to approximately 30.6 months)

• PFS Rate at 6 Months

  Month 6

• OS Rate at 6 Months and 12 Months

  Months 6 and 12

Study Arms (2)

Atezolizumab + Tiragolumab

EXPERIMENTAL

Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.

Drug: Atezolizumab; Drug: Tiragolumab

Atezolizumab + Placebo

PLACEBO COMPARATOR

Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.

Drug: Atezolizumab; Drug: Placebo

Interventions

Atezolizumab DRUG

Atezolizumab at a fixed dose of 1200 mg will be administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.

Also known as: Tecentriq, RO5541267

Atezolizumab + Placebo; Atezolizumab + Tiragolumab

Tiragolumab DRUG

Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Also known as: RO7092284

Atezolizumab + Tiragolumab

Placebo DRUG

Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Atezolizumab + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed recurrent/metastatic SCCHN involving the oropharynx, oral cavity, larynx, or hypopharynx, that is considered incurable by local therapies
• Known results from human papillomavirus (HPV) status test for oropharyngeal carcinoma
• No prior systemic therapy for metastatic and/or recurrent SCCHN
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Tumor PD-L1 expression as determined by PD-L1 immunohistochemistry assay
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy \>=12 weeks

You may not qualify if:

• Disease suitable for local therapy with curative intent
• Progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced SCCHN
• Rapidly progressing disease in the opinion of the treating investigator
• Grade \>=2 unresolved toxicity related to surgery or other prior therapies
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• History of leptomeningeal disease
• Active or history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• History of additional malignancy other than SCCHN within 5 years prior to randomization
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-TIGIT, anti-PD-L1, and anti-PD-1 therapeutic antibodies
• Treatment with systemic immunostimulatory agents or systemic immunosuppressive medication
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (47)

Moores Cancer Center at UC San Diego Health

La Jolla, California, 92093, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

SCRI Florida Cancer Specialists PAN

Tallahassee, Florida, 32308, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Tennessee Oncology - Nashville

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Masarykuv onkologicky ustav

Brno, 656 53, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

CHU Bordeaux

Bordeaux, 33075, France

Location

Centre Francois Baclesse

Caen, 14076, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut régional du Cancer Montpellier

Montpellier, 34298, France

Location

Institut Curie

Paris, 75231, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Anticancer Hospital Ag Savas

Athens, 115 22, Greece

Location

Attiko Hospital University of Athens

Athens, 12462, Greece

Location

Periph. University General Hospital of Heraklion Crete

Heraklion, 711 10, Greece

Location

Euromedical General Clinic of Thessaloniki

Thessaloniki, 546 45, Greece

Location

Gy?r-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

Gy?r, 9024, Hungary

Location

Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont

Kecskemét, 6000, Hungary

Location

Pécsi Tudományegyetem

Pécs, 7623, Hungary

Location

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, 25100, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

Auckland City Hospital, Cancer and Blood Research

Auckland, 1023, New Zealand

Location

Beskidzkie Centrum Onkologii- Szpital Miejski

Bielsko-Biala, 43-300, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gda?sk, 80-214, Poland

Location

Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, 90-242, Poland

Location

Centrum Onkologii Ziemi Lubelskiej Im. ?W. Jana Z Dukli

Lublin, 20-090, Poland

Location

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Institut Catala d Oncologia Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112201, Taiwan

Location

National Taiwan University Hospital

Zhongzheng Dist., 10048, Taiwan

Location

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust, Guys Hospital

London, SE1 9RT, United Kingdom

Location

Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

atezolizumab; Tiragolumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: March 2, 2021
• Primary Completion: September 20, 2023
• Study Completion: August 27, 2025
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TH (2); GB (4); GR (4); IT (3); KR (3); ES (3); FR (6); HU (3); US (7); NZ (1); CZ (3); TW (3); PL (5)