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

Recruiting in Palo Alto (17 mi)

+282 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).

Eligibility Criteria

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.

Inclusion Criteria

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

I am fully active or can carry out light work.

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

+5 more

Exclusion Criteria

I haven't had cancer, other than esophageal, in the last 2 years.

I have previously received treatments targeting the immune system.

I have not received any experimental treatments for esophageal cancer.

+4 more

Participant Groups

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.

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.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: