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Closed (no longer recruiting)Last updated: 2 February 2024

SKYSCRAPER-07: This phase III trial will evaluate how safe and effective two types of immunotherapy are, compared to a placebo, for the treatment of locally advanced oesophageal squamous cell cancerA Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody), in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

Clinical summary

Summary

Eligible patients will be randomised into one of three Arms (A, B or C). In Arm A, patients will receive atezolizumab followed by tiragolumab. In Arm B, patients will receive atezolizumab followed by tiragolumab matching placebo. And, in Arm C, patients will receive matching placebos for both tiragolumab and atezolizumab.

Conditions

This trial is treating patients with oesophageal squamous cell cancer.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

III

Trial Acronym

SKYSCRAPER-07

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody), in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
  • Unresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study
  • dCRT treatment according to regional oncology guidelines for esophageal cancer
  • Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT
  • Adequate hematologic and end-organ function prior to randomization
  • Women of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later
  • Men must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.

Exclusion

  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-TIGIT therapeutic antibodies
  • Any unresolved toxicity of National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 from the prior chemoradiation therapy with the exception of irreversible and manageable hearing loss
  • Prior allogeneic stem cell or solid organ transplantation
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
  • Malignancies other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Treatment with any other investigational agent, including epidermal growth factor receptor (EGFR) inhibitors, with therapeutic intent for esophageal cancer prior to randomization.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
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Clinical trials have complex eligibility criteria.

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