Pembrolizumab in HNSCC With Residual Disease After Radiation
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 24
Summary
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The primary objective is to determine the overall response to pembrolizumab for patients with residual disease following radiation with or without systemic therapy for squamous cell carcinoma of the head and neck. Hypothesis: The use of pembrolizumab in patients with residual disease following radia...
The primary objective is to determine the overall response to pembrolizumab for patients with residual disease following radiation with or without systemic therapy for squamous cell carcinoma of the head and neck. Hypothesis: The use of pembrolizumab in patients with residual disease following radiation with or without systemic therapy will lead to an enhanced overall response rate due to treatment-related priming of the immune response. When initially registered, the study used a follow up assessment of 12 weeks. However, the actual study aims for the primary and secondary outcomes were updated to 168 weeks. The primary completion date was also updated to reflect the primary outcome timeline.
Tracking Information
- NCT #
- NCT02892201
- Collaborators
- Merck Sharp & Dohme Corp.
- Investigators
- Principal Investigator: Barbara Burtness, MD Yale School of Medicine
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