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

Squamous Cell Carcinoma of Head and Neck Clinical Trial

— SKYSCRAPER-09  

Official title:

A Phase II, Randomized, Double Blind 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04665843
• Other study ID #: BO42533
• Secondary ID: 2020-002852-19
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2, 2021
• Est. completion date: October 2, 2024

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 123
• Est. completion date: October 2, 2024
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Atezolizumab
Atezolizumab at a fixed dose of 1200 mg will be administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
• Tiragolumab
Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
• Placebo
Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Locations

Country	Name	City	State
Czechia	Masarykuv onkologicky ustav	Brno
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol	Praha 5
France	Centre Francois Baclesse; Oncologie	Caen
France	Centre Leon Berard; Departement Oncologie Medicale	Lyon
France	Institut régional du Cancer Montpellier	Montpellier
France	Institut Curie; Oncologie Medicale	Paris
France	CHU Bordeaux	Pessac
France	Institut de Cancérologie de Lorraine	Vandoeuvre-Les-Nancy
Greece	Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine	Athens
Greece	Attiko Hospital University of Athens; 2Nd Dept. of Propaedeutic Medicine	Athens
Greece	Periph. University General Hospital of Heraklion Crete; Oncology Department	Heraklion
Greece	Euromedical General Clinic of Thessaloniki; Oncology Department	Thessaloniki
Hungary	Gy?r-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház	Gy?r
Hungary	Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet	Pécs
Italy	Asst Degli Spedali Civili Di Brescia	Brescia	Lombardia
Italy	Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia	Firenze	Toscana
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo	Milano	Lombardia
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
New Zealand	Auckland City Hospital, Cancer and Blood Research	Auckland
New Zealand	Christchurch Hospital NZ	Christchurch
New Zealand	Tauranga Hospital, Clinical Trials Unit; BOP Clinical School	Tauranga
New Zealand	Wellington Hospital	Wellington
Poland	Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna	?ód?
Poland	Beskidzkie Centrum Onkologii- Szpital Miejski	Bielsko- Biala
Poland	Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii	Gdansk
Poland	CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ?W. JANA Z DUKLI; II Oddzia? Onkologii Klinicznej	Lublin
Poland	Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzia? Onkologii Klinicznej i Doswiadczalnej	Poznan
Spain	Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia	Badalona	Barcelona
Spain	Institut Catala d Oncologia Hospital Duran i Reynals	Barcelona
Spain	Hospital Universitari i Politecnic La Fe; Oncologia	Valencia
Taiwan	China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H	Taichung
Taiwan	Taipei Veterans General Hospital; Department of Oncology	Taipei City
Taiwan	National Taiwan University Hospital; Oncology	Zhongzheng Dist.
Thailand	Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc	Bangkok
Thailand	Songklanagarind Hospital; Department of Oncology	Songkhla
United Kingdom	Velindre Cancer Centre	Cardiff
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Guys and St Thomas NHS Foundation Trust, Guys Hospital	London
United Kingdom	The Royal Marsden Hospital, Fulham	London
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	MD Anderson Cancer Center; Oncology	Houston	Texas
United States	Moores Cancer Center at UC San Diego Health	La Jolla	California
United States	UCLA	Los Angeles	California
United States	Tennessee Oncology - Nashville	Nashville	Tennessee
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	SCRI Florida Cancer Specialists PAN	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Czechia,  France,  Greece,  Hungary,  Italy,  Korea, Republic of,  New Zealand,  Poland,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed Objective Response Rate (ORR)		Up to approximately 43 months
Secondary	Duration of Response (DOR)		Up to approximately 43 months
Secondary	Progression-Free Survival (PFS)		Up to approximately 43 months
Secondary	Overall Survival (OS)		Up to approximately 43 months
Secondary	Progression-Free Survival Rate at 6 Months		Month 6
Secondary	Overall Survival Rate at 6 Months and 12 Months		Month 6, Month 12
Secondary	Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning		Up to approximately 43 months
Secondary	Percentage of Participants With Adverse Events (AEs)		Up to approximately 43 months
Secondary	Minimum Serum Concentration (Cmin) of Atezolizumab		Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months
Secondary	Maximum Serum Concentration (Cmax) of Atezolizumab		Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months
Secondary	Cmin of Tiragolumab		Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months
Secondary	Cmax of Tiragolumab		Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months
Secondary	Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab		From baseline up to approximately 43 months
Secondary	Number of Participants With ADAs to Tiragolumab		From baseline up to approximately 43 months