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Checkpoint Inhibitor

Atezolizumab +/− Tiragolumab for Esophageal Cancer (SKYSCRAPER-07 Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

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

Must not have

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

Treatment with any other investigational agent, including epidermal growth factor receptor (EGFR) inhibitors, with therapeutic intent for esophageal cancer prior to randomization.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 6 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new immunotherapy drug combination to see if it is more effective than the current standard of care for esophageal cancer.

Who is the study for?

This trial is for adults with esophageal squamous cell carcinoma that can't be removed by surgery and hasn't worsened after chemoradiotherapy. They must have good physical function, no serious unresolved side effects from prior treatments, no autoimmune diseases or recent other cancers, and agree to contraception.

What is being tested?

The study tests the effectiveness of Tiragolumab with Atezolizumab versus placebo in patients. Participants are randomly assigned to one of three groups: both drugs, one drug plus placebo, or double placebo to compare outcomes.

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in various organs, infusion reactions similar to allergic responses during treatment administration, fatigue, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer cannot be removed by surgery, as confirmed by a specialist.

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I am receiving or have received standard dCRT for esophageal cancer.

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My diagnosis is squamous cell carcinoma of the esophagus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously received treatments targeting the immune system.

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I have not received any experimental treatments for esophageal cancer.

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I have a history of certain lung conditions or currently have active lung inflammation.

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I have had a stem cell or organ transplant in the past.

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I have or had an autoimmune disease or immune deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Percentage of Participants With Clinically Meaningful Changes in Dysphagia as Measured by EORTC QLQ-OES18

Percentage of Participants With Clinically Meaningful Changes in Physical Functioning, Role Functioning, Quality of Life (QoL) as Measured by EORTC QLQ-C30