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NCT04665843 · ClinicalTrials.gov registry record · Phase 2
A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study of Squamous Cell Carcinoma of Head and Neck, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
- 20
- Study locations
NCT04665843: Completed Phase 2 study of Squamous Cell Carcinoma of Head and Neck, sponsored by Hoffmann-La Roche.
NCT04665843 is a Phase 2 study of Squamous Cell Carcinoma of Head and Neck that has completed, run by Hoffmann-La Roche. The registered enrollment target is 123 participants, below the 167-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04665843, a Phase 2 study of Squamous Cell Carcinoma of Head and Neck, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.
Primary Outcome
A confirmed objective response rate (ORR) was defined as the percentage of participants with a confirmed objective response (OR), characterized by a complete response (CR) or a partial response (PR), on 2 consecutive occasions ≥ 4 weeks apart, as determined by the investigator per RECIST v1.1. CR was defined as the disappearance of all target and non-target lesions \& normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduct
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Atezolizumab
- DRUG Tiragolumab
Study Locations (20)
Other
- Masarykuv onkologicky ustav - Brno
- Fakultni nemocnice Hradec Kralove - Hradec Králové
- Fakultni nemocnice v Motole - Prague
- CHU Bordeaux - Bordeaux
- Centre Francois Baclesse - Caen
- Centre Leon Berard - Lyon
- Institut régional du Cancer Montpellier - Montpellier
- Institut Curie - Paris
- Institut de Cancérologie de Lorraine - Vandœuvre-lès-Nancy
- Anticancer Hospital Ag Savas - Athens
- Attiko Hospital University of Athens - Athens
- Periph. University General Hospital of Heraklion Crete - Heraklion
- Euromedical General Clinic of Thessaloniki - Thessaloniki
California
- Moores Cancer Center at UC San Diego Health - La Jolla
- UCLA - Los Angeles
Florida
- SCRI Florida Cancer Specialists PAN - Tallahassee
Maryland
- Johns Hopkins Hospital - Baltimore
Missouri
- Washington University School of Medicine - St Louis
Tennessee
- Tennessee Oncology - Nashville - Nashville
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2025-08-27 |
| Phase | Phase 2 |
What the finished NCT04665843 record still lists
NCT04665843 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 167-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Squamous Cell Carcinoma of Head and Neck appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04665843 names 20 study sites across 7 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04665843 about?
NCT04665843 is a clinical study titled "A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck". The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. I...
What is the current status of trial NCT04665843?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2021-03-02. Estimated completion is 2025-08-27.
What conditions does trial NCT04665843 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of Head and Neck.
What interventions are being tested in trial NCT04665843?
The interventions under investigation include: Placebo (DRUG), Atezolizumab (DRUG), Tiragolumab (DRUG).
Who is sponsoring clinical trial NCT04665843?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04665843 being conducted?
This trial has 20 study locations across California, Florida, Maryland, Missouri, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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