Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck
- Conditions
- Squamous Cell Carcinoma of Head and NeckHead and Neck Cancer
- Interventions
- Biological: enoblituzumabBiological: MGA012Biological: MGD013
- Registration Number
- NCT04129320
- Lead Sponsor
- MacroGenics
- 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 cell carcinoma of the head and neck (SCCHN).
- 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, will occur independently in a non-randomized fashion. Data from these modules will determine if further evaluation will occur in randomized Module A (Phase 2) and randomized Module B (Phase 3).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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%)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Arm 1 enoblituzumab Enoblituzumab plus MGA012 Experimental Arm 1 MGA012 Enoblituzumab plus MGA012 Experimental Arm 2 enoblituzumab Enoblituzumab plus MGD013 Experimental Arm 2 MGD013 Enoblituzumab plus MGD013
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events as assessed by CTCAE v 4.03 (Modules X and Y) Up to 30 days after last dose of study drug Evaluation of adverse events and serious adverse events
Overall Response Rate (Modules X and Y) 2 years Proportion of patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1
- Secondary Outcome Measures
Name Time Method Duration of Response - (Modules X and Y) 2 years Time from the date of initial response to the date of first documented progression or death from any cause, whichever occurs first
Ctrough (Module X) 2 years Trough serum concentration of enoblituzumab and MGA012
Immunogenicity (Module X) 2 years Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGA012
Ctrough (Module Y) 2 years Trough serum concentration of enoblituzumab and MGD013
Progression-free Survival - (Modules X and Y) 2 years Time from start of study treatment to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Disease Control Rate - (Modules X and Y) 2 years Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment
Immunogenicity (Module Y) 2 years Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGD013
Cmax (Module Y) 2 years Maximum serum concentration of enoblituzumab and MGD013
Cmax (Module X) 2 years Maximum serum concentration of enoblituzumab and MGA012