Trials / Withdrawn
WithdrawnNCT04831450
Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)
Phase II Trial of Maintenance Cemiplimab-rwlc After Concurrent Chemoradiotherapy (CRT) in Intermediate and High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Miami · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the experimental immunotherapy agent cemiplimab-rwlc when given after completion of chemotherapy and radiation treatment and determine if it will improve progression free survival and cure rates in patients with PD-L1 positive locally advanced head and neck cancer.
Conditions
- Head and Neck Squamous Cell Carcinoma
- HNSCC
- Squamous Cell Carcinoma of the Larynx
- Squamous Cell Carcinoma of the Oral Cavity
- Squamous Cell Carcinoma of Hypopharynx
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cemiplimab-Rwlc | 350 mg Cemiplimab administered via intravenous infusion over 30 minutes on Day 1 of a 21-day cycle. |
Timeline
- Start date
- 2022-07-01
- Primary completion
- 2022-07-15
- Completion
- 2022-07-15
- First posted
- 2021-04-05
- Last updated
- 2022-08-04
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04831450. Inclusion in this directory is not an endorsement.