Clinical trial NCT04129320: Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck
Official title: A Phase 2/3 Open-Label Trial to Evaluate Enoblituzumab in Combination With MGA012 or MGD013 in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Head and Neck Cancer
Squamous Cell Carcinoma of Head and Neck
Keywords: SCCHN
head and neck
oropharyngeal
oral cavity
hypopharyngeal
laryngeal cancer
immunotherapy
PD-1
B7-H3
LAG-3
Lead sponsor: MacroGenics
Sponsor class: INDUSTRY
First posted: 2019-10-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel study model refers to concurrent enrollment of non-randomized Modules X and Y.
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Overall Response Rate (Modules X and Y)
timeFrame: 2 years
measure: Incidence of Adverse Events as assessed by CTCAE v 4.03 (Modules X and Y)
timeFrame: Up to 30 days after last dose of study drug
Secondary outcomes:
measure: Progression-free Survival - (Modules X and Y)
timeFrame: 2 years
measure: Disease Control Rate - (Modules X and Y)
timeFrame: 2 years
measure: Duration of Response - (Modules X and Y)
timeFrame: 2 years
measure: Immunogenicity (Module X)
timeFrame: 2 years
measure: Immunogenicity (Module Y)
timeFrame: 2 years
measure: Cmax (Module X)
timeFrame: 2 years
measure: Ctrough (Module X)
timeFrame: 2 years
measure: Cmax (Module Y)
timeFrame: 2 years
measure: Ctrough (Module Y)
timeFrame: 2 years
Other outcomes:
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