Back to resultsA 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 (SKYSCRAPER-09)
Primary Purpose
Squamous Cell Carcinoma of Head and Neck
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Tiragolumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of Head and Neck
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
Sites / Locations
- Moores Cancer Center at UC San Diego Health
- UCLA
- SCRI Florida Cancer Specialists PAN
- Johns Hopkins Hospital
- Washington University School of Medicine
- Tennessee Onc., PLLC - SCRI
- MD Anderson Cancer Center; Oncology
- Masarykuv onkologicky ustav
- Fakultni nemocnice Hradec Kralove
- Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol
- Centre Francois Baclesse; Oncologie
- Centre Leon Berard; Departement Oncologie Medicale
- Institut régional du Cancer Montpellier
- Institut Curie; Oncologie Medicale
- CHU Bordeaux
- Institut de Cancérologie de Lorraine
- Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
- Attiko Hospital University of Athens; 2Nd Dept. of Propaedeutic Medicine
- Periph. University General Hospital of Heraklion Crete; Oncology Department
- Euromedical General Clinic of Thessaloniki; Oncology Department
- Gy?r-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
- Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
- Asst Degli Spedali Civili Di Brescia
- Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo
- Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
- Seoul National University Hospital
- Asan Medical Center
- Samsung Medical Center
- Auckland City Hospital, Cancer and Blood Research
- Christchurch Hospital NZ
- Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
- Wellington Hospital
- Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
- Beskidzkie Centrum Onkologii- Szpital Miejski
- Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
- CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ?W. JANA Z DUKLI; II Oddzia? Onkologii Klinicznej
- Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzia? Onkologii Klinicznej i Doswiadczalnej
- Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
- Institut Catala d Oncologia Hospital Duran i Reynals
- Hospital Universitari i Politecnic La Fe; Oncologia
- China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H
- Taipei Veterans General Hospital; Department of Oncology
- National Taiwan University Hospital; Oncology
- Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
- Songklanagarind Hospital; Department of Oncology
- Clatterbridge Cancer Centre
- Velindre Cancer Centre
- Beatson West of Scotland Cancer Centre
- Guys and St Thomas NHS Foundation Trust, Guys Hospital
- The Royal Marsden Hospital, Fulham
- Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Atezolizumab + Tiragolumab
Atezolizumab + Placebo
Arm Description
Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.
Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
Outcomes
Primary Outcome Measures
Confirmed Objective Response Rate (ORR)
Secondary Outcome Measures
Duration of Response (DOR)
Progression-Free Survival (PFS)
Overall Survival (OS)
Progression-Free Survival Rate at 6 Months
Overall Survival Rate at 6 Months and 12 Months
Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning
Percentage of Participants With Adverse Events (AEs)
Minimum Serum Concentration (Cmin) of Atezolizumab
Maximum Serum Concentration (Cmax) of Atezolizumab
Cmin of Tiragolumab
Cmax of Tiragolumab
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Number of Participants With ADAs to Tiragolumab
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04665843
Brief Title
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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
September 20, 2023 (Actual)
Study Completion Date
October 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Head and Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atezolizumab + Tiragolumab
Arm Type
Experimental
Arm Description
Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.
Arm Title
Atezolizumab + Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq; RO5541267
Intervention Description
Atezolizumab at a fixed dose of 1200 mg will be administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab
Other Intervention Name(s)
RO7092284
Intervention Description
Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Confirmed Objective Response Rate (ORR)
Time Frame
Up to approximately 43 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Time Frame
Up to approximately 43 months
Title
Progression-Free Survival (PFS)
Time Frame
Up to approximately 43 months
Title
Overall Survival (OS)
Time Frame
Up to approximately 43 months
Title
Progression-Free Survival Rate at 6 Months
Time Frame
Month 6
Title
Overall Survival Rate at 6 Months and 12 Months
Time Frame
Month 6, Month 12
Title
Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning
Time Frame
Up to approximately 43 months
Title
Percentage of Participants With Adverse Events (AEs)
Time Frame
Up to approximately 43 months
Title
Minimum Serum Concentration (Cmin) of Atezolizumab
Time Frame
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
Title
Maximum Serum Concentration (Cmax) of Atezolizumab
Time Frame
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
Title
Cmin of Tiragolumab
Time Frame
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
Title
Cmax of Tiragolumab
Time Frame
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
Title
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Time Frame
From baseline up to approximately 43 months
Title
Number of Participants With ADAs to Tiragolumab
Time Frame
From baseline up to approximately 43 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Moores Cancer Center at UC San Diego Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
SCRI Florida Cancer Specialists PAN
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Tennessee Onc., PLLC - SCRI
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
MD Anderson Cancer Center; Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Centre Francois Baclesse; Oncologie
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Leon Berard; Departement Oncologie Medicale
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut régional du Cancer Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
CHU Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre-Les-Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
City
Athens
ZIP/Postal Code
115 22
Country
Greece
Facility Name
Attiko Hospital University of Athens; 2Nd Dept. of Propaedeutic Medicine
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Periph. University General Hospital of Heraklion Crete; Oncology Department
City
Heraklion
ZIP/Postal Code
711 10
Country
Greece
Facility Name
Euromedical General Clinic of Thessaloniki; Oncology Department
City
Thessaloniki
ZIP/Postal Code
546 45
Country
Greece
Facility Name
Gy?r-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
City
Gy?r
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Asst Degli Spedali Civili Di Brescia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Auckland City Hospital, Cancer and Blood Research
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Christchurch Hospital NZ
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6002
Country
New Zealand
Facility Name
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
City
?ód?
ZIP/Postal Code
90-338
Country
Poland
Facility Name
Beskidzkie Centrum Onkologii- Szpital Miejski
City
Bielsko- Biala
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ?W. JANA Z DUKLI; II Oddzia? Onkologii Klinicznej
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzia? Onkologii Klinicznej i Doswiadczalnej
City
Poznan
Country
Poland
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Institut Catala d Oncologia Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe; Oncologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Taipei Veterans General Hospital; Department of Oncology
City
Taipei City
ZIP/Postal Code
112201
Country
Taiwan
Facility Name
National Taiwan University Hospital; Oncology
City
Zhongzheng Dist.
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Songklanagarind Hospital; Department of Oncology
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Clatterbridge Cancer Centre
City
Bebington
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust, Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
The Royal Marsden Hospital, Fulham
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
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
We'll reach out to this number within 24 hrs