Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
NCT ID: NCT04634825
Last Updated: 2023-12-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
62 participants
INTERVENTIONAL
2021-03-17
2022-07-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Retifanlimab Cohort
Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles
Enoblituzumab
Anti-B7-H3 antibody
Retifanlimab
Anti-PD-1 antibody
Tebotelimab Cohort
Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles
Enoblituzumab
Anti-B7-H3 antibody
Tebotelimab
PD-1 X LAG-3 bispecific DART molecule
Interventions
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Enoblituzumab
Anti-B7-H3 antibody
Retifanlimab
Anti-PD-1 antibody
Tebotelimab
PD-1 X LAG-3 bispecific DART molecule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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MacroGenics
INDUSTRY
Responsible Party
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Principal Investigators
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Ashley L. Ward, MD
Role: STUDY_DIRECTOR
MacroGenics
Locations
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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
The Ewa Pilecka Department of Clinical Oncology
Bialystok, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
I Clinics of Radiotherapy and Chemiotherapy; The Maria Sklodowska-Curie National Research Institute of Oncology
Gliwice, , Poland
Biokinetica
Józefów, , Poland
Clinics of Head and Neck Cancer, The Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, , Poland
Complejo Hospitalario Universitario de Badajoz
Badajoz, , Spain
Hospital Universitario Vall D'Hebrón
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Universitario Virgen de la Macarena
Seville, , Spain
Communal Non-profit Enterprise "City Clinical Hospital#4" of Dnipro City
Dnipro, , Ukraine
Communal Non-Profit Enterprise "Regional Center of Oncology", Oncosurgical Department of Head and Neck
Kharkiv, , Ukraine
Communal Non-profit Enterprise "Regional Clinical Oncology Center of Kirovohrad Regional Council",
Kropyvnytskyi, , Ukraine
Kyiv City Clinical Oncological Centre
Kyiv, , Ukraine
Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Dispensary"
Sumy, , Ukraine
Communal Nonprofit Enterprise Podilsky Regional Center of Oncology
Vinnytsia, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CP-MGA271-06
Identifier Type: -
Identifier Source: org_study_id