SKYSCRAPER-09: 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
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Atezolizumab + Tiragolumab Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle. |
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.
Other Names:
Drug: Tiragolumab
Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Other Names:
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Placebo Comparator: Atezolizumab + Placebo Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle. |
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.
Other Names:
Drug: Placebo
Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
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Outcome Measures
Primary Outcome Measures
- Confirmed Objective Response Rate (ORR) [Up to approximately 43 months]
Secondary Outcome Measures
- Duration of Response (DOR) [Up to approximately 43 months]
- Progression-Free Survival (PFS) [Up to approximately 43 months]
- Overall Survival (OS) [Up to approximately 43 months]
- Progression-Free Survival Rate at 6 Months [Month 6]
- Overall Survival Rate at 6 Months and 12 Months [Month 6, Month 12]
- Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning [Up to approximately 43 months]
- Percentage of Participants With Adverse Events (AEs) [Up to approximately 43 months]
- 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]
- 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]
- 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]
- 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]
- Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab [From baseline up to approximately 43 months]
- Number of Participants With ADAs to Tiragolumab [From baseline up to approximately 43 months]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Histologically or cytologically confirmed recurrent/metastatic SCCHN involving the oropharynx, oral cavity, larynx, or hypopharynx, that is considered incurable by local therapies
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Known results from human papillomavirus (HPV) status test for oropharyngeal carcinoma
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No prior systemic therapy for metastatic and/or recurrent SCCHN
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Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Tumor PD-L1 expression as determined by PD-L1 immunohistochemistry assay
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Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
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Life expectancy >=12 weeks
Key Exclusion Criteria:
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Disease suitable for local therapy with curative intent
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Progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced SCCHN
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Rapidly progressing disease in the opinion of the treating investigator
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Grade >=2 unresolved toxicity related to surgery or other prior therapies
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Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
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History of leptomeningeal disease
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Active or history of autoimmune disease or immune deficiency
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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
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History of additional malignancy other than SCCHN within 5 years prior to randomization
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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
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Treatment with systemic immunostimulatory agents or systemic immunosuppressive medication
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Pregnancy or breastfeeding
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Moores Cancer Center at UC San Diego Health | La Jolla | California | United States | 92093 |
2 | UCLA | Los Angeles | California | United States | 90095 |
3 | SCRI Florida Cancer Specialists PAN | Tallahassee | Florida | United States | 32308 |
4 | Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | United States | 30060 |
5 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21231 |
6 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
7 | Tennessee Onc., PLLC - SCRI | Nashville | Tennessee | United States | 37203 |
8 | MD Anderson Cancer Center; Oncology | Houston | Texas | United States | 77030 |
9 | Masarykuv onkologicky ustav | Brno | Czechia | 656 53 | |
10 | Fakultni nemocnice Hradec Kralove | Hradec Kralove | Czechia | 500 05 | |
11 | Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol | Praha 5 | Czechia | 150 06 | |
12 | Centre Francois Baclesse; Oncologie | Caen | France | 14076 | |
13 | Centre Leon Berard; Departement Oncologie Medicale | Lyon | France | 69373 | |
14 | Institut régional du Cancer Montpellier | Montpellier | France | 34298 | |
15 | Institut Curie; Oncologie Medicale | Paris | France | 75231 | |
16 | CHU Bordeaux | Pessac | France | 33604 | |
17 | Institut de Cancérologie de Lorraine | Vandoeuvre-Les-Nancy | France | 54519 | |
18 | Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine | Athens | Greece | 115 22 | |
19 | Attiko Hospital University of Athens; 2Nd Dept. of Propaedeutic Medicine | Athens | Greece | 12462 | |
20 | Periph. University General Hospital of Heraklion Crete; Oncology Department | Heraklion | Greece | 711 10 | |
21 | Euromedical General Clinic of Thessaloniki; Oncology Department | Thessaloniki | Greece | 546 45 | |
22 | Uzsoki Utcai Korhaz; Onkoradiológiai Osztály | Budapest | Hungary | 1145 | |
23 | Petz Aladar Megyei Oktato Korhaz; Oncoradiologia | Gyor | Hungary | 9024 | |
24 | Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont; Onkoradiologiai Kozpont | Kecskemet | Hungary | 6000 | |
25 | Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet | Pécs | Hungary | 7623 | |
26 | Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo | Lugo | Emilia-Romagna | Italy | 48022 |
27 | Asst Degli Spedali Civili Di Brescia | Brescia | Lombardia | Italy | 25123 |
28 | Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo | Milano | Lombardia | Italy | 20133 |
29 | Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia | Firenze | Toscana | Italy | 50134 |
30 | IOV - Istituto Oncologico Veneto IRCCS | Padova | Veneto | Italy | 35128 |
31 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
32 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
33 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
34 | Auckland City Hospital, Cancer and Blood Research | Auckland | New Zealand | 1023 | |
35 | Christchurch Hospital NZ | Christchurch | New Zealand | 8011 | |
36 | Tauranga Hospital, Clinical Trials Unit; BOP Clinical School | Tauranga | New Zealand | 3112 | |
37 | Wellington Hospital | Wellington | New Zealand | 6002 | |
38 | Beskidzkie Centrum Onkologii- Szpital Miejski | Bielsko- Biala | Poland | 43-300 | |
39 | Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol | Brzozów | Poland | 36-200 | |
40 | Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii | Gdańsk | Poland | 80-214 | |
41 | Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | Poland | 90-242 | |
42 | CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ŚW. JANA Z DUKLI; II Oddział Onkologii Klinicznej | Lublin | Poland | 20-090 | |
43 | Szpital Kliniczny im. H. Swiecickiego w Poznaniu; Oddział Onkologii Klinicznej i Doswiadczalnej | Poznan | Poland | ||
44 | Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Badalona | Barcelona | Spain | 08916 |
45 | Institut Catala d Oncologia Hospital Duran i Reynals | Barcelona | Spain | 08908 | |
46 | Hospital Universitari i Politecnic La Fe; Oncologia | Valencia | Spain | 46026 | |
47 | China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H | Taichung | Taiwan | 404 | |
48 | Taipei Veterans General Hospital; Department of Oncology | Taipei City | Taiwan | 112201 | |
49 | National Taiwan University Hospital; Oncology | Zhongzheng Dist. | Taiwan | 10048 | |
50 | Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok | Thailand | 10400 | |
51 | Songklanagarind Hospital; Department of Oncology | Songkhla | Thailand | 90110 | |
52 | Clatterbridge Cancer Centre | Bebington | United Kingdom | CH63 4JY | |
53 | Velindre Cancer Centre | Cardiff | United Kingdom | CF14 2TL | |
54 | Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom | G12 0YN | |
55 | Guys and St Thomas NHS Foundation Trust, Guys Hospital | London | United Kingdom | SE1 9RT | |
56 | The Royal Marsden Hospital, Fulham | London | United Kingdom | SW3 6JJ | |
57 | Royal Marsden NHS Foundation Trust | Sutton | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BO42533
- 2020-002852-19