Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

MacroGenics

Status and phase: Terminated; Phase 2

Conditions: Head and Neck Neoplasms; Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma

Treatments: Biological: Retifanlimab; Biological: Enoblituzumab; Biological: Tebotelimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04634825

CP-MGA271-06

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Retifanlimab Cohort

Experimental group

Description:

Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles

Treatment:

Biological: Enoblituzumab

Biological: Retifanlimab

Tebotelimab Cohort

Experimental group

Description:

Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles

Treatment:

Biological: Tebotelimab

Biological: Enoblituzumab