← Back to Search

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

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
Select...
I am fully active or can carry out light work.
Select...
My cancer cannot be removed by surgery, as confirmed by a specialist.
Select...
I am receiving or have received standard dCRT for esophageal cancer.
Select...
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:
Select...
I have previously received treatments targeting the immune system.
Select...
I have not received any experimental treatments for esophageal cancer.
Select...
I have a history of certain lung conditions or currently have active lung inflammation.
Select...
I have had a stem cell or organ transplant in the past.
Select...
I have or had an autoimmune disease or immune deficiency.

Timeline

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

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm B: Tiragolumab Placebo + AtezolizumabExperimental Treatment2 Interventions
Participants will receive atezolizumab followed by tiragolumab matching placebo.
Group II: Arm A: Tiragolumab + AtezolizumabExperimental Treatment2 Interventions
Participants will receive atezolizumab followed by tiragolumab.
Group III: Arm C: Tiragolumab Placebo + Atezolizumab PlaceboPlacebo Group2 Interventions
Participants will receive matching placebos to tiragolumab and atezolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tiragolumab
2019
Completed Phase 3
~1400
Atezolizumab
2017
Completed Phase 3
~5850
Tiragolumab Matching Placebo
2020
Completed Phase 3
~550

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,444 Previous Clinical Trials
1,092,362 Total Patients Enrolled
Clinical TrialStudy DirectorHoffmann-La Roche
9 Previous Clinical Trials
1,510 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04543617 — Phase 3
Esophageal Carcinoma Research Study Groups: Arm C: Tiragolumab Placebo + Atezolizumab Placebo, Arm A: Tiragolumab + Atezolizumab, Arm B: Tiragolumab Placebo + Atezolizumab
Esophageal Carcinoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04543617 — Phase 3
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04543617 — Phase 3
~292 spots leftby Mar 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top