Trials / Completed
CompletedNCT02296684
Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma
Immunotherapy With MK-3475 in Locoregionally Advanced, Surgically Resectable Head and Neck Squamous Cell Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this trial is to test the ability of MK-3475 (pembrolizumab) to improve locoregional recurrence and distant metastatic rates in high-risk patients with locally advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current standard of care surgical approaches.
Conditions
- Cancer of Head and Neck
- Head and Neck Cancer
- Neoplasms, Head and Neck
- Carcinoma, Squamous Cell of Head and Neck
- Squamous Cell Carcinoma of the Head and Neck
- Squamous Cell Carcinoma, Head and Neck
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MK-3475 (neoadjuvant) | |
| PROCEDURE | Surgery | Standard of care |
| RADIATION | Intensity modulated radiation therapy | Recommended, standard of care |
| RADIATION | Image-guided radiation therapy | Recommended, standard of care |
| DRUG | Cisplatin | Standard of care |
| BIOLOGICAL | MK-3475 (adjuvant) | |
| PROCEDURE | Peripheral blood | -Baseline, time of surgery (between day 14-24 inclusive), 3 months post surgery, 6 months post surgery, 9 months post surgery, 12 months post surgery |
Timeline
- Start date
- 2015-03-25
- Primary completion
- 2022-04-05
- Completion
- 2025-07-21
- First posted
- 2014-11-20
- Last updated
- 2026-01-15
- Results posted
- 2023-05-11
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02296684. Inclusion in this directory is not an endorsement.