A clinical trial to evaluate atezolizumab plus tiragolumab and atezolizumab alone in people with squamous cell carcinoma of the head and neck

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

  • Squamous Cell Carcinoma
Trial Status:

Active, not recruiting

This trial runs in
Cities
  • Athens
  • Athina
  • Auckland
  • Badalona
  • Baltimore
  • Bielsko-Biała
  • Bordeaux
  • Brescia
  • Brzozów
  • Budapest
  • Caen
  • Cardiff
  • Chaidari
  • Christchurch
  • Florence
  • Gdańsk
  • Glasgow
  • Győr
  • Hlavní město Praha
  • Houston
  • Hradec Králové
  • Jihomoravský kraj
  • Kecskemét
  • Kho Hong
  • Krung Thep Maha Nakhon
  • L'Hospitalet de Llobregat
  • London
  • Los Angeles
  • Lublin
  • Lugo
  • Lyon
  • Marietta
  • Milano
  • Montpellier
  • Nashville
  • Padova
  • Paris
  • Pessac
  • Poznań
  • Pécs
  • Reno
  • San Diego
  • Seoul
  • St. Louis
  • Sutton
  • Taichung City
  • Taipei City
  • Tallahassee
  • tambon-kho-hong
  • Tauranga
  • Thessaloniki
  • València
  • Vandœuvre-lès-Nancy
  • Wellington
  • Wirral
  • Łódź
Trial Identifier:

NCT04665843 2020-002852-19 BO42533

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT04665843 , BO42533 , 2020-002852-19 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      How does the BO42533 clinical trial work?
      This clinical trial is recruiting people who have a particular type of head and neck cancer called squamous cell carcinoma of the head and neck (SCCHN). In order to take part, patients must have SCCHN that has come back after treatment from an earlier SCCHN diagnosis (recurrent) or SCCHN that has spread to other parts of the body (metastatic).

      The purpose of this clinical trial is to study the effects, good or bad, of atezolizumab plus tiragolumab and atezolizumab alone in patients with SCCHN. In this clinical trial, you will get either atezolizumab plus tiragolumab or atezolizumab plus a placebo.

      How do I take part in this clinical trial?
      To be able to take part in this clinical trial, you must be diagnosed with recurrent/metastatic SCCHN that has not been treated.

      You must not have any other significant health conditions or have a history of another type of cancer (other than SCCHN) within the last 5 years. If you have previously received certain treatments within a particular amount of time before the study, you may not be able to take part.

      If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

      You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

      Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part. 

      While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons. 

      What treatment will I be given if I join this clinical trial?
      Everyone who joins this clinical trial will be split into two groups: 

      • Group A will receive atezolizumab, given as an infusion into the vein every 3 weeks, and tiragolumab, also given as an infusion into the vein every 3 weeks
      • Group B will receive atezolizumab, given as an infusion into the vein every 3 weeks, and a placebo, also given an infusion into the vein every 3 weeks 

      Twice as many people will be entered into Group A than Group B, meaning you will have a 

      2 in 3 chance of receiving atezolizumab plus tiragolumab and a 1 in 3 chance of receiving atezolizumab plus placebo

      This is a ‘placebo-controlled’ clinical trial, which means that one of the groups will be given a medicine with no active ingredients. A placebo is used to show that the doctor or the patients do not sway the results of the clinical trial.

      Neither you nor your clinical trial doctor can choose or know the group you are in. However, your clinical trial doctor can find out which group you are in, if your safety is at risk 

      How often will I be seen in follow-up appointments and for how long?
      You will be given the clinical trial treatment atezolizumab plus tiragolumab OR atezolizumab plus a placebo for as long as it can help you. You are free to stop this treatment at any time. You will be seen regularly by the clinical trial doctor every 3 weeks while you receive treatment. These hospital visits will include checks to see how you are responding to the treatment and any side effects that you may be having. 

      What happens if I am unable to take part in this clinical trial?
      If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

      For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04665843

      Trial-identifier: NCT04665843

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT04665843 , BO42533 , 2020-002852-19 Trial Identifier
      Atezolizumab, Tiragolumab, Placebo Treatments
      Squamous Cell Carcinoma of Head and Neck Condition
      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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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
      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

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