Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
MacroGenics
Study ID
NCT04634825
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enoblituzumab — BIOLOGICAL
    Anti-B7-H3 antibody
  • Retifanlimab — BIOLOGICAL
    Anti-PD-1 antibody
  • Tebotelimab — BIOLOGICAL
    PD-1 X LAG-3 bispecific DART molecule

Study Details

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.

Key Dates

Start date
Mar 17, 2021
Status verified
Dec 2023
Primary completion
Jul 29, 2022
Completion
Jul 29, 2022

Study Design

Enrollment
62 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Retifanlimab Cohort
    Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles
  • Experimental: Tebotelimab Cohort
    Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles

Primary Outcome Measure

Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab [ Time Frame: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months. ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Maryland, Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-
University of MichiganAnn ArborMichigan48109-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
University of North Carolina - Lineberger Cancer CenterChapel HillNorth Carolina27514-
University of Pennsylvania - Abramson Cancer CenterPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical Center- Hillman Cancer CenterPittsburghPennsylvania15232-

Find similar trials in Baltimore, MD

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Maryland, Greenebaum Comprehensive Cancer Center· Baltimore, MDUniversity of Michigan· Ann Arbor, MIComprehensive Cancer Centers of Nevada· Las Vegas, NVUniversity of North Carolina - Lineberger Cancer Center· Chapel Hill, NCUniversity of Pennsylvania - Abramson Cancer Center· Philadelphia, PAUniversity of Pittsburgh Medical Center- Hillman Cancer Center· Pittsburgh, PA

Related Studies