ALX148 in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Head and Neck Cancer
- Head and Neck Squamous Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 + pembrolizumab + 5FU and platinum and of pembrolizumab + 5FU and platinum alone in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The...
This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 + pembrolizumab + 5FU and platinum and of pembrolizumab + 5FU and platinum alone in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The study comprises of an initial safety lead-in followed by a randomized portion.
Tracking Information
- NCT #
- NCT04675333
- Collaborators
- Merck Sharp & Dohme Corp.
- Investigators
- Not Provided
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