Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

Stopped early · Phase 2

Conditions studied: Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma

In brief

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 facts

Study ID: NCT04634825
Run by: MacroGenics
People needed: 62
Starts: 2021-03-17
Expected to finish: 2022-07-29
Last updated by the study team: 2023-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Positive (combined positive score [CPS] ≥ 1) for the retifanlimab cohort, or
Negative (CPS < 1) for the tebotelimab cohort
Results available from human papilloma virus p16 status for oropharyngeal cancer
Acceptable laboratory results

You may not qualify if…

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

Where it is running

University of Maryland, Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States
University of Michigan — Ann Arbor, Michigan, United States
Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
University of North Carolina - Lineberger Cancer Center — Chapel Hill, North Carolina, United States
University of Pennsylvania - Abramson Cancer Center — Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center- Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
Liverpool Hospital — Liverpool, New South Wales, Australia
Monash Health, Medical Oncology Department — Ruse, New South Wales, Australia
Royal North Shore Hospital — Sydney, New South Wales, Australia
Calvary Mater Newcastle — Waratah, New South Wales, Australia
Icon Cancer Centre Southport — Southport, Queensland, Australia
Andrew Love Cancer Centre, Barwon Health — Geelong, Victoria, Australia
Fiona Stanley Hospital — Murdoch, Western Australia, Australia
Complex Oncology Center Ruse Ltd. — Dobrich, Bulgaria
MHAT Serdica — Panagyurishte, Bulgaria
MBAL Uni Hospital — Pleven, Bulgaria
MHAT Nadezhda, Medical Oncology — Sofia, Bulgaria
UMHAT Tsarisa Yoanna - ISUL — Sofia, Bulgaria
UMHAT Georgi Stranski Medical Oncology Department — Sofia, Bulgaria
COC Dobrich — Sofia, Bulgaria
Bajcsy-Zsilinszky Korhaz — Budapest, Hungary
Uzsoki Street Hospital — Budapest, Hungary
Dept of Oncology, University of Debrecen — Debrecen, Hungary
Dept of Oncology, Bekec County Hosp — Gyula, Hungary
Dept of Oncology, Tolna County Hospital — Szekszárd, Hungary

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.