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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 (SKYSCRAPER-09)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04665843
Recruitment Status : Active, not recruiting
First Posted : December 14, 2020
Last Update Posted : December 12, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE December 7, 2020
First Posted Date  ICMJE December 14, 2020
Last Update Posted Date December 12, 2022
Actual Study Start Date  ICMJE March 2, 2021
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 43 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • Duration of Response (DOR) [ Time Frame: Up to approximately 43 months ]
  • Progression-Free Survival (PFS) [ Time Frame: Up to approximately 43 months ]
  • Overall Survival (OS) [ Time Frame: Up to approximately 43 months ]
  • Progression-Free Survival Rate at 6 Months [ Time Frame: Month 6 ]
  • Overall Survival Rate at 6 Months and 12 Months [ Time Frame: Month 6, Month 12 ]
  • Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning [ Time Frame: Up to approximately 43 months ]
  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 43 months ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab [ Time Frame: From baseline up to approximately 43 months ]
  • Number of Participants With ADAs to Tiragolumab [ Time Frame: From baseline up to approximately 43 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of Head and Neck
Intervention  ICMJE
  • 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 Name: 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 Name: RO7092284
  • Drug: Placebo
    Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Study Arms  ICMJE
  • Experimental: Atezolizumab + Tiragolumab
    Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.
    Interventions:
    • Drug: Atezolizumab
    • Drug: Tiragolumab
  • Placebo Comparator: Atezolizumab + Placebo
    Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
    Interventions:
    • Drug: Atezolizumab
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2, 2024
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   France,   Greece,   Hungary,   Italy,   Korea, Republic of,   New Zealand,   Poland,   Spain,   Taiwan,   Thailand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04665843
Other Study ID Numbers  ICMJE BO42533
2020-002852-19 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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).
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP