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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 6 years

Awards & highlights

SKYSCRAPER-07 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.Check my eligibility

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.See study design

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.

SKYSCRAPER-07 Trial 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.

SKYSCRAPER-07 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Upper arm

Arm A vs Arm C: Overall Survival (OS)

Arm B vs Arm C: OS

Secondary outcome measures

Arm A vs Arm B: Investigator-Assessed PFS

Arm A vs Arm B: OS

Arm B vs Arm C: Investigator-Assessed PFS

+12 more

SKYSCRAPER-07 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

2020

Completed Phase 2

~350

Atezolizumab

2017

Completed Phase 3

~5860

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,308 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 Cancer Research Study Groups: Arm C: Tiragolumab Placebo + Atezolizumab Placebo, Arm A: Tiragolumab + Atezolizumab, Arm B: Tiragolumab Placebo + Atezolizumab

Esophageal Cancer 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for new patients to enroll in this clinical trial?

"Yes, this trial is still open and recruiting patients. The initial posting was on September 28th, 2020 with the latest update occurring on October 26th, 2022."

Answered by AI

What makes this research unique compared to other projects?

"Atezolizumab is being used in 357 active clinical trials spread out over 74 countries and 1665 cities. The first study began in 2008 and was sponsored by Hoffmann-La Roche. It completed its Phase 2 drug approval stage with 720 patients. 79 studies have been completed since then."

Answered by AI

In how many different geographical areas is this research being conducted?

"To limit travel-based stressors, it is ideal to choose a trial site close to your home. Currently, this study is running at 10 sites which are located in Corona, Easton, Wichita and other locations."

Answered by AI

How many test subjects are currently enrolled in this experiment?

"To move forward with the trial, a total of 750 eligible patients are needed. The sponsor of the study, Hoffmann-La Roche, will be working out of multiple medical facilities to reach this number. For example, Compassionate Cancer Care Medical Group, Inc in Corona, California and St. Luke's Hospital - Anderson Campus in Easton, Pennsylvania are both participating locations."

Answered by AI

Does Atezolizumab have the green light from the FDA?

"Atezolizumab is a Phase 3 clinical trial medication, meaning that it has undergone some efficacy testing and multiple rounds of safety trials. Our team rates its safety as a 3 on a scale from 1 to 3."

Answered by AI

For what purpose is Atezolizumab most commonly prescribed?

"Atezolizumab is an immunotherapy treatment that can be used to target small cell lung cancer (SCLC), malignant neoplasms, and non-small cell lung carcinoma."

Answered by AI

What are some similar investigations that have utilized Atezolizumab?

"Atezolizumab was first studied in 2008 by Can Care Assoc Med Group Inc; Beach Cities Offices. As of now, a total of 79 trials have been completed while 357 are still recruiting participants. A large number these ongoing trials are based in Corona, California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy

2020. "A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04543617.

All > Squamous Cell Carcinoma