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

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
Hoffmann-La Roche
Study ID
NCT04543617
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tiragolumab — DRUG
    Tiragolumab at a fixed dose of 600 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Atezolizumab — DRUG
    Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
  • Tiragolumab Matching Placebo — DRUG
    Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
  • Atezolizumab Matching Placebo — DRUG
    Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Study Details

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).

Key Dates

Start date
Sep 28, 2020
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
760 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Tiragolumab + Atezolizumab
    Participants will receive atezolizumab followed by tiragolumab.
  • Experimental: Arm B: Tiragolumab Placebo + Atezolizumab
    Participants will receive atezolizumab followed by tiragolumab matching placebo.
  • Placebo Comparator: Arm C: Tiragolumab Placebo + Atezolizumab Placebo
    Participants will receive matching placebos to tiragolumab and atezolizumab.

Primary Outcome Measure

Arm A vs Arm C: Investigator-Assessed Progression-Free Survival (PFS) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Florida Cancer Specialists - Fort Myers (Broadway)Fort MyersFlorida33901-
Cancer Center of KansasWichitaKansas67214-3728-
Great Lakes Cancer CenterWilliamsvilleNew York14221-

Find similar trials in Fort Myers, FL

By research site
Florida Cancer Specialists - Fort Myers (Broadway)· Fort Myers, FLCancer Center of Kansas· Wichita, KSGreat Lakes Cancer Center· Williamsville, NY

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