Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Head and Neck Cancer
- Cutaneous Squamous Cell Carcinoma
- Head and Neck Neoplasms
- Head and Neck Squamous Cell Carcinoma
- Sinonasal Carcinoma
- HNSCC
- Hypopharynx Cancer
- Larynx Cancer
- Lip SCC
- Nasopharynx Cancer
- Oral Cavity Cancer
- Oropharynx Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Open-label, non-randomized, multi-arm phase II trial of pembrolizumab combined with cetuximab for patients with recurrent/metastatic head and neck squamous cell carcinoma Cohort 1 (PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve): clinical efficacy defined as overall response rate. Cohort 2 (PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve): clinical efficacy defined as overall response rate. Cohort 3 (PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory): clinical efficacy defined as overall response rate. Cohort 4 (cutaneous HNSCC): clinical efficacy defined as overall response rate. Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Primary Objectives: To determine the clinical efficacy of pembrolizumab combined with cetuximab for patients with R/M HNSCC. Cohort 1 (PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve): clinical efficacy defined as overall response rate. Cohort 2 (PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve): clinic...
Primary Objectives: To determine the clinical efficacy of pembrolizumab combined with cetuximab for patients with R/M HNSCC. Cohort 1 (PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve): clinical efficacy defined as overall response rate. Cohort 2 (PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve): clinical efficacy defined as overall response rate. Cohort 3 (PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory): clinical efficacy defined as overall response rate. Cohort 4 (cutaneous HNSCC): clinical efficacy defined as overall response rate. Secondary Objectives: To determine 12 month progression-free survival probability. To determine overall survival. To determine duration of response. To assess safety and tolerability of pembrolizumab combined with cetuximab. To evaluate the correlation between molecular markers and disease outcome.
Tracking Information
- NCT #
- NCT03082534
- Collaborators
- Merck Sharp & Dohme Corp.
- Investigators
- Study Chair: Assuntina Sacco, M.D. University of California, San Diego
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