Clinical trial NCT04665843: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of Head and Neck
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Confirmed Objective Response Rate (ORR)
timeFrame: Up to approximately 43 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to approximately 43 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 43 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 43 months
measure: Progression-Free Survival Rate at 6 Months
timeFrame: Month 6
measure: Overall Survival Rate at 6 Months and 12 Months
timeFrame: Month 6, Month 12
measure: Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning
timeFrame: Up to approximately 43 months
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 43 months
measure: Minimum Serum Concentration (Cmin) of Atezolizumab
timeFrame: 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
measure: Maximum Serum Concentration (Cmax) of Atezolizumab
timeFrame: 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
measure: Cmin of Tiragolumab
timeFrame: 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
measure: Cmax of Tiragolumab
timeFrame: 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
measure: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
timeFrame: From baseline up to approximately 43 months
measure: Number of Participants With ADAs to Tiragolumab
timeFrame: From baseline up to approximately 43 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Tallahassee
country: United States
facility: SCRI Florida Cancer Specialists PAN
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Nashville
country: United States
facility: Tennessee Oncology - Nashville
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Caen
country: France
facility: Centre Francois Baclesse
city: Lyon
country: France
facility: Centre Leon Berard
city: Montpellier
country: France
facility: Institut régional du Cancer Montpellier
city: Paris
country: France
facility: Institut Curie
city: Vandoeuvre-Les-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Athens
country: Greece
facility: Attiko Hospital University of Athens
city: Heraklion
country: Greece
facility: Periph. University General Hospital of Heraklion Crete
city: Thessaloniki
country: Greece
facility: Euromedical General Clinic of Thessaloniki
city: Gy?r
country: Hungary
facility: Gy?r-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
state: Toscana
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Auckland
country: New Zealand
facility: Auckland City Hospital, Cancer and Blood Research
city: Gda?sk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej Im. ?W. Jana Z Dukli
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Institut Catala d Oncologia Hospital Duran i Reynals
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Zhongzheng Dist.
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: