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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)

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ClinicalTrials.gov Identifier: NCT04665843
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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
Squamous Cell Carcinoma of Head and Neck Drug: Atezolizumab Drug: Tiragolumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2, 2021
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


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 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

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 Name: Tecentriq; RO5541267

Drug: Placebo
Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.




Primary Outcome Measures :
  1. Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 43 months ]

Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Up to approximately 43 months ]
  2. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 43 months ]
  3. Overall Survival (OS) [ Time Frame: Up to approximately 43 months ]
  4. Progression-Free Survival Rate at 6 Months [ Time Frame: Month 6 ]
  5. Overall Survival Rate at 6 Months and 12 Months [ Time Frame: Month 6, Month 12 ]
  6. Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning [ Time Frame: Up to approximately 43 months ]
  7. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 43 months ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab [ Time Frame: From baseline up to approximately 43 months ]
  13. Number of Participants With ADAs to Tiragolumab [ Time Frame: From baseline up to approximately 43 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665843


Contacts
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Contact: Reference Study ID Number: BO42533 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04665843    
Other Study ID Numbers: BO42533
2020-002852-19 ( EudraCT Number )
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Atezolizumab
Antineoplastic Agents