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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04665843
Collaborator
(none)
120
57
2
43
2.1
0

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 2, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Oct 2, 2024

Arms and Interventions

Arm Intervention/Treatment
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:
  • Tecentriq; RO5541267
  • 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:
  • RO7092284
  • 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:
  • Tecentriq; RO5541267
  • Drug: Placebo
    Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Outcome Measures

    Primary Outcome Measures

    1. Confirmed Objective Response Rate (ORR) [Up to approximately 43 months]

    Secondary Outcome Measures

    1. Duration of Response (DOR) [Up to approximately 43 months]

    2. Progression-Free Survival (PFS) [Up to approximately 43 months]

    3. Overall Survival (OS) [Up to approximately 43 months]

    4. Progression-Free Survival Rate at 6 Months [Month 6]

    5. Overall Survival Rate at 6 Months and 12 Months [Month 6, Month 12]

    6. Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning [Up to approximately 43 months]

    7. Percentage of Participants With Adverse Events (AEs) [Up to approximately 43 months]

    8. 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]

    9. 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]

    10. 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]

    11. 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]

    12. Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab [From baseline up to approximately 43 months]

    13. Number of Participants With ADAs to Tiragolumab [From baseline up to approximately 43 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT04665843
    Other Study ID Numbers:
    • BO42533
    • 2020-002852-19
    First Posted:
    Dec 14, 2020
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2022