Description:
This is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab
administered as first-line treatment to patients with recurrent or metastatic squamous cell
carcinoma of the head and neck.
Title
- Brief Title: Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
- Official Title: A Phase 2 Open-Label Trial to Evaluate Enoblituzumab in Combination With Retifanlimab or Tebotelimab in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Clinical Trial IDs
- ORG STUDY ID:
CP-MGA271-06
- NCT ID:
NCT04634825
Conditions
- Head and Neck Cancer
- Head and Neck Neoplasms
- Head and Neck Squamous Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Enoblituzumab | MGA271 | Retifanlimab Cohort |
Retifanlimab | INCMGA00012, MGA012 | Retifanlimab Cohort |
Tebotelimab | MGD013 | Tebotelimab Cohort |
Purpose
This is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab
administered as first-line treatment to patients with recurrent or metastatic squamous cell
carcinoma of the head and neck.
Detailed Description
This is an open-label, non-randomized study of approximately 80 patients. Enrollment into
each cohort will occur independently, with 50 programmed cell death ligand 1 (PD-L1)-positive
patients enrolled in the retifanlimab cohort, and 30 PD-L1-negative patients enrolled in the
tebotelimab cohort.
Trial Arms
Name | Type | Description | Interventions |
---|
Retifanlimab Cohort | Experimental | Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles | - Enoblituzumab
- Retifanlimab
|
Tebotelimab Cohort | Experimental | Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles | |
Eligibility Criteria
Inclusion Criteria:
- Histologically proven, recurrent or metastatic squamous cell carcinoma of the head and
neck (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 if given as part of
multimodal treatment for locally advanced disease)
- Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Patients
may not have a primary tumor site of upper esophagus, salivary gland, or nasopharynx
(any histology)
- Availability of formalin-fixed, paraffin embedded tumor specimen or contemporary
biopsy for immunohistochemical evaluation of pharmacodynamic markers of interest
- Willing to consent for baseline and on-treatment biopsy.
- Performance status 0 or 1
- Life expectancy of 6 months or more
- Adequate end organ function
- At least one radiographically measurable lesion
- PD-L1 expression level that is either
1. Positive (combined positive score [CPS] ≥ 1) for the retifanlimab cohort, or
2. Negative (CPS < 1) for the tebotelimab cohort
- Results available from human papilloma virus p16 status for oropharyngeal cancer
- Acceptable laboratory results
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 prior to the first dose of
study drug
- Prior therapy with an anti-B7-H3, anti-PD-1, anti-PD-L1, or anti-LAG-3 agent
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Efficacy of enoblituzumab plus retifanlimab |
Time Frame: | 28 months |
Safety Issue: | |
Description: | Investigator-assessed objective response rate (complete response [CR] or partial response [PR]) |
Secondary Outcome Measures
Measure: | Progression-free survival |
Time Frame: | 28 months |
Safety Issue: | |
Description: | Time from the first dose date to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort |
Measure: | Disease-control rate |
Time Frame: | 28 months |
Safety Issue: | |
Description: | Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort |
Measure: | Duration of response |
Time Frame: | 28 months |
Safety Issue: | |
Description: | Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort |
Measure: | Overall survival |
Time Frame: | 28 months |
Safety Issue: | |
Description: | Time from the first dose date to the date of death from any cause, evaluated by cohort |
Measure: | Safety of enoblituzumab plus retifanlimab |
Time Frame: | 30 days after last dose |
Safety Issue: | |
Description: | Incidence of treatment-emergent adverse events |
Measure: | Pharmacokinetics of enoblituzumab plus retifanlimab |
Time Frame: | up to 42 weeks |
Safety Issue: | |
Description: | Serum concentration of enoblituzumab and retifanlimab |
Measure: | Pharmacokinetics of enoblituzumab plus tebotelimab |
Time Frame: | up to 42 weeks |
Safety Issue: | |
Description: | Serum concentration of enoblituzumab and tebotelimab |
Measure: | Immunogenicity of enoblituzumab plus retifanlimab |
Time Frame: | 28 months |
Safety Issue: | |
Description: | Proportion of patients who develop anti-drug antibodies |
Measure: | Immunogenicity of enoblituzumab plus tebotelimab |
Time Frame: | 28 months |
Safety Issue: | |
Description: | Proportion of patients who develop anti-drug antibodies |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | MacroGenics |
Trial Keywords
- SCCHN, head and neck, oropharyngeal, oral cavity, hypopharyngeal, laryngeal cancer, immunotherapy, PD-1, B7-H3, Lymphocyte Activation Gene-3 (LAG-3)
Last Updated
July 26, 2021