A Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Conditions

• Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Atezolizumab intravenous infusion will be administered at a fixed dose on Day 1 of each 21-day cycle for 16 cycles.
• Placebo — DRUG
  Placebo intravenous infusion will be administered a fixed dose on Day 1 of each 21-day cycle for 16 cycles.

Study Details

This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Key Dates

Start date

Apr 3, 2018

Status verified

Sep 2024

Primary completion

Sep 27, 2023

Completion

Mar 6, 2024

Study Design

Enrollment

406 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Atezolizumab
  Participants will receive Atezolizumab for 16 cycles, or up to 1 year (whichever occurs first)
• Experimental: Placebo
  Participants will receive Placebo for 16 cycles, or up to 1 year (whichever occurs first).

Primary Outcome Measure

Investigator-Assessed Event-Free Survival (INV-assessed EFS) [ Time Frame: Randomization to the first documented disease recurrence, disease progression or death from any cause, whichever occurs first (up to 5 years) ]

Locations (12)

Find similar trials in Duarte, CA