Squamous Cell Carcinoma of Head and Neck Clinical Trial
— SKYSCRAPER-09Official 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
| Verified date | April 2024 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Czechia, France, Greece, Hungary, Italy, Korea, Republic of, New Zealand, Poland, Spain, Taiwan, Thailand, United Kingdom,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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