A Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Participants With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Carcinoma

Sponsor
Hoffmann-La Roche
Study ID
NCT04540211
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab at a fixed dose of 1200 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Tiragolumab — DRUG
    Tiragolumab at a fixed dose of 600 mg administered by IV infusion every Q3W on Day 1 of each 21-day cycle.
  • Paclitaxel — DRUG
    Paclitaxel 175 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles.
  • Cisplatin — DRUG
    Cisplatin 60-80 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles.
  • Atezolizumab Matching Placebo — DRUG
    Atezolizumab matching placebo 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.

Study Details

The purpose of this study is to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin (PC) compared with atezolizumab matching placebo plus tiragolumab matching placebo plus PC as first-line treatment in participants with unresectable locally advanced, unresectable recurrent, or metastatic esophageal carcinoma (EC). Participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during induction phase: Arm A: Atezolizumab plus Tiragolumab and PC Arm B: Atezolizumab placebo plus Tiragolumab placebo and PC Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab matching placebo plus tiragolumab matching placebo (Arm B).

Key Dates

Start date
Oct 30, 2020
Status verified
Mar 2026
Primary completion
Feb 13, 2023
Completion
Aug 28, 2025

Study Design

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

Arms

  • Experimental: Atezolizumab + Tiragolumab + PC
    Participants will receive atezolizumab and tiragolumab on Day 1 of each 21-day cycle during the study followed by paclitaxel and cisplatin on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the induction treatment phase.
  • Placebo Comparator: Placebo + PC
    Participants will receive atezolizumab matching placebo and tiragolumab matching placebo on Day 1 of each 21-day cycle during the study followed by paclitaxel and cisplatin on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the induction treatment phase.

Primary Outcome Measure

Independent Review Facility (IRF)-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 19 months) ]

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