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NCT03452137 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 406
- Enrollment target
NCT03452137: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT03452137 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 406 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03452137, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 406 participants
- Enrollment target
Study Summary
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)
Primary Outcome
EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression \[per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)\] per assessment by investigator, or death from any cause, whichever occurred first. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters (SOD)
Interventions
- DRUG Placebo
- DRUG Atezolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2018-04-03 |
| Est. Completion | 2024-03-06 |
| Phase | Phase 3 |
Why NCT03452137 stopped before completion
NCT03452137 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03452137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03452137 about?
NCT03452137 is a clinical study titled "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". 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)
What is the current status of trial NCT03452137?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 406 participants. The study started on 2018-04-03. Estimated completion is 2024-03-06.
What interventions are being tested in trial NCT03452137?
The interventions under investigation include: Placebo (DRUG), Atezolizumab (DRUG).
Who is sponsoring clinical trial NCT03452137?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03452137's enrollment target sits among peer trials
406 913th of 2000 higher than 1,087 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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