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

2023-509449-10-00 Protocol BO42533 Therapeutic exploratory (Phase II) Ended

Start 16 Mar 2021 · End 28 Aug 2025 · Status Ended · 6 EU/EEA countries · 13 sites · Protocol BO42533

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ended
Participants planned 115
Countries 6
Sites 13

Squamous cell carcinoma of the head and neck (SCCHN)

To evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo on the basis of confirmed objective response rate

Key facts

Sponsor
F. Hoffmann-La Roche AG
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
16 Mar 2021 → 28 Aug 2025
Decision date (initial)
2024-08-01
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
F. Hoffmann-La Roche Ltd

External identifiers

EU CT number
2023-509449-10-00
EudraCT number
2020-002852-19

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Pharmacokinetic, Efficacy, Safety

To evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo on the basis of confirmed objective response rate

Secondary objectives 4

  1. To evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo on the basis of duration of response, progression-free survival, overall survival, progression-free survival rate at 6 months, overall survival rate at 6 months and 12 months and time to confirmed deterioration in patient-reported physical functioning
  2. To evaluate the safety of atezolizumab plus tiragolumab and atezolizumab plus placebo
  3. To characterize the pharmacokinetics of atezolizumab and tiragolumab
  4. To evaluate the immune response to atezolizumab and tiragolumab

Conditions and MedDRA coding

Squamous cell carcinoma of the head and neck (SCCHN)

VersionLevelCodeTermSystem organ class
27.0 LLT 10082179 Squamous cell carcinoma of head and neck metastatic 10029104

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Treatment
Patients will be randomly assigned to one of two treatment arms: atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).
 Randomised Controlled Double [{"id":127266,"code":4,"name":"Analyst"},{"id":127269,"code":2,"name":"Investigator"},{"id":127267,"code":5,"name":"Carer"},{"id":127268,"code":1,"name":"Subject"}] Arm A: Experimental: Atezolizumab + Tiragolumab: Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.
Arm B: Placebo Comparator: Atezolizumab + Placebo: Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. Known results from human papillomavirus status test for 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 status test are required for oropharyngeal carcinoma
  2. No prior systemic therapy for metastatic and/or recurrent SCCHN
  3. Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1
  4. Tumor PD-L1 expression as determined by PD-L1 IHC assay in either a previously obtained archival tumor tissue or tissue obtained from a biopsy at prescreening/screening
  5. Eastern Cooperative Oncology Group Performance Status of 0 or 1
  6. Adequate hematologic and end-organ function

Exclusion criteria 6

  1. Progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced SCCHN
  2. Rapidly progressing disease in the opinion of the treating investigator
  3. Grade >= 2 unresolved toxicity related to surgery or other prior therapies
  4. Symptomatic, untreated, or actively progressing central nervous system metastases
  5. History of leptomeningeal disease
  6. Active or history of autoimmune disease or immune deficiency

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 1. Confirmed objective response rate

Secondary endpoints 10

  1. 1. Duration of Response
  2. 2. Progression free survival
  3. 3. Overall survival
  4. 4. Progression free survival rate at 6 months
  5. 5. Overall survival rate at 6 months and 12 months
  6. 6.Time to confirmed deterioration in patient-reported physical functioning
  7. 7. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0
  8. 8. Serum concentration of atezolizumab and tiragolumab at specified timepoints
  9. 9. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at baseline and during the study
  10. 10.Prevalence of ADAs to tiragolumab at baseline and during the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Tecentriq 1 200 mg concentrate for solution for infusion

PRD5434943 · Product

Active substance
Atezolizumab
Substance synonyms
RO5541267
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1200 mg milligram(s)
Max total dose
40.8 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01FF05 — -
Marketing authorisation
EU/1/17/1220/001
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Secondary packaging and labelling for clinical trial use

Tiragolumab

PRD7846761 · Product

Active substance
Tiragolumab
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
600 mg milligram(s)
Max total dose
20.4 g gram(s)
Max treatment duration
24 Month(s)
Authorisation status
Not Authorised
MA holder
F. HOFFMANN-LA ROCHE LTD
Paediatric formulation
No
Orphan designation
No

Placebo 1

Tiragolumab placebo

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

213 Total trials 63 Recruiting 141 Ended
Commercial
Sponsor organisation
F. Hoffmann-La Roche AG
Address
Grenzacherstrasse 124
City
Basel
Postcode
4058
Country
Switzerland

Scientific contact point

Organisation
F. Hoffmann-La Roche AG
Contact name
Trial Information System - TISL

Public contact point

Organisation
F. Hoffmann-La Roche AG
Contact name
Trial Information System - TISL

Third parties 8

OrganisationCity, countryDuties
Ventana Medical Systems Inc.
ORG-100043193
 Oro Valley, United States Other
Fortrea Inc.
ORG-100012602
 Bannockburn, United States Other
CellCarta
ORG-100039881
 Antwerp, Belgium Other
S-Clinica
ORG-100040718
 Elsene, Belgium Other
IQVIA Limited
ORG-100008655
 Reading, United Kingdom Other
DHL Supply Chain Operations GmbH
ORG-100040715
 Florstadt, Germany Other
Foundation Medicine GmbH
ORG-100040499
 Penzberg, Germany Other
Labcorp Central Laboratory Services LP
ORG-100032236
 Indianapolis, United States Laboratory analysis

Locations

6 EU/EEA countries · 13 investigational sites

By country

CountryMS statusPlanned subjectsSites
Czechia Ended 7 1
France Ended 30 6
Greece Ended 13 1
Hungary Ended 4 1
Poland Ended 13 1
Spain Ended 5 3
Rest of world
Taiwan, United Kingdom, Thailand, United States, Korea, Republic of, New Zealand
 — 43 —

Investigational sites

Czechia

1 site · Ended
Masarykuv Onkologicky Ustav
oddělení klinické onkologie, Zluty Kopec 543/7, Stare Brno, Brno-Stred

France

6 sites · Ended
Institut Regional Du Cancer De Montpellier
Oncologie Medicale, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Institut De Cancerologie De Lorraine
Oncologie Medicale, ORL, 6 Avenue De Bourgogne, Cs 30519, Vandoeuvre Les Nancy Cedex
Centre Leon Berard
Oncologie Medicale, 28 Rue Laennec, 69008, Lyon
Centre Francois Baclesse
Oncologie Medicale, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Institut Curie
Oncologie Medicale, 26 Rue D Ulm, 75005, Paris
Centre Hospitalier Universitaire De Bordeaux
Oncologie Medicale, 1 Rue Jean Burguet, 33000, Bordeaux

Greece

1 site · Ended
University General Hospital Attikon
Oncology Unit, 2nd Propaedeutic Internal Medicine Clinic, Rimini Street 1, 124 62, Athens

Hungary

1 site · Ended
University Of Pecs
Onkoterapias Intezet, Edesanyak Utja 17, 7624, Pecs

Poland

1 site · Ended
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk

Spain

3 sites · Ended
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Germans Trias I Pujol
Oncology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Czechia 2021-05-26 2025-03-10 2021-06-16 2022-05-12
France 2021-06-08 2021-06-08 2022-05-12
Greece 2021-05-21 2024-12-04 2021-07-01 2022-05-12
Hungary 2021-03-31 2025-08-27 2021-04-21 2022-05-12
Poland 2021-03-16 2025-08-13 2021-03-29 2022-05-12
Spain 2021-05-28 2025-01-28 2021-06-28 2022-05-12

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
BO42533_Summary of Results
SUM-128901
 2026-04-14T13:34:11 Submitted Summary of Results

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2023-509449-10-00 Redacted 6
Protocol (for publication) D1_Protocol 2023-509449-10-00 Redacted GR 6
Protocol (for publication) d4_patient-facing-documents_redaction-memo 1
Recruitment arrangements (for publication) K_Rcurit_arrange_France_BO42533 1
Subject information and informed consent form (for publication) L1_BO42533_FRA_ICF_complementaire_redacted 4
Subject information and informed consent form (for publication) L1_BO42533_FRA_ICF_PPA 1
Subject information and informed consent form (for publication) L1_BO42533_FRA_ICF_prescr_redacted 2
Subject information and informed consent form (for publication) L1_BO42533_FRA_ICF_Principal_redacted 6
Subject information and informed consent form (for publication) L1_BO42533_FRA_ICF_RBR_redacted 2
Subject information and informed consent form (for publication) L1_BO42533_FRA_ICF_selles_redacted 3
Summary of results (for publication) BO42533_Summary of Results NA
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG 2023-509449-10-00 1.0
Synopsis of the protocol (for publication) d1_protocol-synopsis_cz-2023-509449-10-00 1.0
Synopsis of the protocol (for publication) d1_protocol-synopsis_es-2023-509449-10-00 1.0
Synopsis of the protocol (for publication) d1_protocol-synopsis_fr-2023-509449-10-00 1.0
Synopsis of the protocol (for publication) d1_protocol-synopsis_gr-2023-509449-10-00 1.0
Synopsis of the protocol (for publication) d1_protocol-synopsis_hu-2023-509449-10-00 1.0
Synopsis of the protocol (for publication) d1_protocol-synopsis_pl-2023-509449-10-00 1.0

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-12 Czechia Acceptable with conditions
2024-07-30
 2024-07-31
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-10-16 Acceptable with conditions
2024-07-30
 2024-10-16
3 SUBSTANTIAL MODIFICATION SM-1 2024-11-15 Czechia Acceptable
2025-01-30
 2025-01-30
4 SUBSTANTIAL MODIFICATION SM-3 2025-06-16 Acceptable
2025-07-30
 2025-07-30

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