Status:
WITHDRAWN
Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
MacroGenics
Conditions:
Head and Neck Cancer
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is an open-label study designed to evaluate safety and efficacy of enoblituzumab in combination with MGA012 or MGD013 in first-line treatment of patients with recurrent or metastatic squamous cel...
Detailed Description
The study will initially be conducted in 2 modules, Module X (enoblituzumab plus MGA012) and Module Y (enoblituzumab plus MGD013). Enrollment into Modules X and Y, with approximately 30 patients each,...
Eligibility Criteria
Inclusion
- Histologically proven, recurrent or metastatic SCCHN not curable by local therapy
- No prior systemic therapy for SCCHN in the recurrent or metastatic setting (with the exception of systemic therapy completed \> 6 months prior of given as part of multimodal treatment for locally advanced disease)
- Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx
- At least one radiographically measurable lesion
- HPV test results available (positive and negative eligible)
- ECOG Performance status of 0 or 1
- Adequate end organ function
- Positive PD-L1 expression level (CPS ≥ 1%)
Exclusion
- Disease suitable for local therapy administered with curative intent
- Progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced SCCHN
- Radiation or other non-systemic therapy within 2 weeks of first dose of study drug
- Diagnosis of immunodeficiency, or use of immunosuppresive therapy within 14 days of first dose of study drug
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04129320
Start Date
October 1 2019
End Date
October 1 2022
Last Update
February 8 2022
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