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Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

Sponsor
MacroGenics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04634825
Collaborator
(none)
80
Enrollment
42
Locations
2
Arms
36.5
Anticipated Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Enoblituzumab
  • Biological: Retifanlimab
  • Biological: Tebotelimab
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Enrollment into each cohort will occur independently in a non-randomized fashion, based on PD-L1 expression results. Patients may not crossover between cohorts.Enrollment into each cohort will occur independently in a non-randomized fashion, based on PD-L1 expression results. Patients may not crossover between cohorts.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 17, 2021
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Retifanlimab Cohort

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

Biological: Enoblituzumab
Anti-B7-H3 antibody
Other Names:
  • MGA271

    • Biological: Retifanlimab
    Anti-PD-1 antibody
    Other Names:
  • INCMGA00012, MGA012

    		•
    Experimental: Tebotelimab Cohort

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

    Biological: Enoblituzumab
    Anti-B7-H3 antibody
    Other Names:
  • MGA271

    • Biological: Tebotelimab
    PD-1 X LAG-3 bispecific DART molecule
    Other Names:
  • MGD013

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of enoblituzumab plus retifanlimab [28 months]

      Investigator-assessed objective response rate (complete response [CR] or partial response [PR])

    2. Safety of enoblituzumab plus tebotelimab [30 days after last dose]

      Incidence of treatment-emergent adverse events

    3. Efficacy of enoblituzumab plus tebotelimab [28 months]

      Investigator-assessed objective response rate

    Secondary Outcome Measures

    1. Progression-free survival [28 months]

      Time from the first dose date to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort

    2. Disease-control rate [28 months]

      Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort

    3. Duration of response [28 months]

      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

    4. Overall survival [28 months]

      Time from the first dose date to the date of death from any cause, evaluated by cohort

    5. Safety of enoblituzumab plus retifanlimab [30 days after last dose]

      Incidence of treatment-emergent adverse events

    6. Pharmacokinetics of enoblituzumab plus retifanlimab [up to 42 weeks]

      Serum concentration of enoblituzumab and retifanlimab

    7. Pharmacokinetics of enoblituzumab plus tebotelimab [up to 42 weeks]

      Serum concentration of enoblituzumab and tebotelimab

    8. Immunogenicity of enoblituzumab or retifanlimab [28 months]

      Proportion of patients who develop anti-drug antibodies to enoblituzumab or retifanlimab

    9. Immunogenicity of enoblituzumab or tebotelimab [28 months]

      Proportion of patients who develop anti-drug antibodies to enoblituzumab or tebotelimab.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Maryland, Greenebaum Comprehensive Cancer Center Baltimore Maryland United States 21201
    2 University of Michigan Ann Arbor Michigan United States 48109
    3 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89169
    4 University of North Carolina - Lineberger Cancer Center Chapel Hill North Carolina United States 27514
    5 University of Pennsylvania - Abramson Cancer Center Philadelphia Pennsylvania United States 19104
    6 University of Pittsburgh Medical Center- Hillman Cancer Center Pittsburgh Pennsylvania United States 15232
    7 Liverpool Hospital Liverpool New South Wales Australia 2170
    8 Monash Health, Medical Oncology Department Ruse New South Wales Australia 3168
    9 Royal North Shore Hospital Sydney New South Wales Australia 2065
    10 Calvary Mater Newcastle Waratah New South Wales Australia 2298
    11 Icon Cancer Centre Southport Southport Queensland Australia 4215
    12 Andrew Love Cancer Centre, Barwon Health Geelong Victoria Australia 3220
    13 Fiona Stanley Hospital Murdoch Western Australia Australia 6150
    14 Complex Oncology Center Ruse Ltd. Dobrich Bulgaria 7002
    15 MHAT Serdica Panagyurishte Bulgaria 1632
    16 MBAL Uni Hospital Pleven Bulgaria 4500
    17 MHAT Nadezhda, Medical Oncology Sofia Bulgaria 1373
    18 UMHAT Tsarisa Yoanna - ISUL Sofia Bulgaria 1527
    19 UMHAT Georgi Stranski Medical Oncology Department Sofia Bulgaria 5800
    20 COC Dobrich Sofia Bulgaria 9300
    21 Bajcsy-Zsilinszky Korhaz Budapest Hungary 01106
    22 Uzsoki Street Hospital Budapest Hungary 1145
    23 Dept of Oncology, University of Debrecen Debrecen Hungary 04032
    24 Dept of Oncology, Bekec County Hosp Gyula Hungary 5700
    25 Dept of Oncology, Tolna County Hospital Szekszard Hungary 7100
    26 The Ewa Pilecka Department of Clinical Oncology Bialystok Poland 15027
    27 Uniwersyteckie Centrum Kliniczne Gdańsk Poland 80-214
    28 I Clinics of Radiotherapy and Chemiotherapy; The Maria Sklodowska-Curie National Research Institute of Oncology Gliwice Poland 44-102
    29 Biokinetica Jozefow Poland 05-410
    30 Clinics of Head and Neck Cancer, The Maria Sklodowska-Curie National Research Institute of Oncology Warszawa Poland
    31 Complejo Hospitalario Universitario de Badajoz Badajoz Spain 06080
    32 Hospital Universitario Vall D'Hebrón Barcelona Spain 08035
    33 Hospital Clínic de Barcelona Barcelona Spain 08036
    34 Hospital Clínico San Carlos Madrid Spain 28040
    35 Clinica Universidad de Navarra Pamplona Spain 31008
    36 Hospital Universitario Virgen de la Macarena Sevilla Spain 41009
    37 Communal Non-profit Enterprise "City Clinical Hospital#4" of Dnipro City Dnipro Ukraine 49102
    38 Communal Non-Profit Enterprise "Regional Center of Oncology", Oncosurgical Department of Head and Neck Kharkiv Ukraine 61070
    39 Communal Non-profit Enterprise "Regional Clinical Oncology Center of Kirovohrad Regional Council", Kropyvnytskyi Ukraine 25000
    40 Kyiv City Clinical Oncological Centre Kyiv Ukraine 03115
    41 Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Dispensary" Sumy Ukraine 40022
    42 Communal Nonprofit Enterprise Podilsky Regional Center of Oncology Vinnytsia Ukraine 21029

    Sponsors and Collaborators

    • MacroGenics

    Investigators

    • Study Director: Ashley L. Ward, MD, MacroGenics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MacroGenics
    ClinicalTrials.gov Identifier:
    NCT04634825
    Other Study ID Numbers:
    • CP-MGA271-06
    First Posted:
    Nov 18, 2020
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Head and Neck Neoplasms
    Squamous Cell Carcinoma of Head and Neck

    Study Results

    No Results Posted as of May 18, 2022