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).
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
anti-B7-H3 antibody
anti-PD-1 antibody
PD-1 X LAG-3 bispecific DART protein
Overall Response Rate (Modules X and Y)
Proportion of patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1
Time frame: 2 years
Incidence of Adverse Events as assessed by CTCAE v 4.03 (Modules X and Y)
Evaluation of adverse events and serious adverse events
Time frame: Up to 30 days after last dose of study drug
Progression-free Survival - (Modules X and Y)
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.
Time frame: 2 years
Disease Control Rate - (Modules X and Y)
Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment
Time frame: 2 years
Duration of Response - (Modules X and Y)
Time from the date of initial response to the date of first documented progression or death from any cause, whichever occurs first
Time frame: 2 years
Immunogenicity (Module X)
Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGA012
Time frame: 2 years
Immunogenicity (Module Y)
Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGD013
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cmax (Module X)
Maximum serum concentration of enoblituzumab and MGA012
Time frame: 2 years
Ctrough (Module X)
Trough serum concentration of enoblituzumab and MGA012
Time frame: 2 years
Cmax (Module Y)
Maximum serum concentration of enoblituzumab and MGD013
Time frame: 2 years
Ctrough (Module Y)
Trough serum concentration of enoblituzumab and MGD013
Time frame: 2 years