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History of Changes for Study: NCT04634825
Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
Latest version (submitted May 16, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 12, 2020 None (earliest Version on record)
2 March 1, 2021 Recruitment Status, Contacts/Locations, Study Status and Oversight
3 April 13, 2021 Study Status
4 July 23, 2021 Contacts/Locations and Study Status
5 September 7, 2021 Contacts/Locations, Outcome Measures, Study Status, IPDSharing, Conditions and Study Description
6 October 11, 2021 Contacts/Locations and Study Status
7 November 12, 2021 Contacts/Locations and Study Status
8 December 7, 2021 Study Status and Contacts/Locations
9 December 13, 2021 Contacts/Locations and Study Status
10 January 14, 2022 Study Status and Contacts/Locations
11 February 25, 2022 Contacts/Locations and Study Status
12 April 14, 2022 Contacts/Locations and Study Status
13 May 16, 2022 Contacts/Locations and Study Status
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Study NCT04634825
Submitted Date:  November 12, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: CP-MGA271-06
Brief Title: Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Not yet recruiting
Study Start: February 2021
Primary Completion: April 2024 [Anticipated]
Study Completion: April 2024 [Anticipated]
First Submitted: November 12, 2020
First Submitted that
Met QC Criteria:
November 12, 2020
First Posted: November 18, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
November 12, 2020
Last Update Posted: November 18, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: MacroGenics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
Detailed Description: This is an open-label, non-randomized study of approximately 80 patients. Enrollment into each cohort will occur independently, with 50 programmed cell death ligand 1 (PD-L1)-positive patients enrolled in the retifanlimab cohort, and 30 PD-L1-negative patients enrolled in the tebotelimab cohort.
Open or close this module Conditions
Conditions: Head and Neck Cancer
Head and Neck Neoplasms
Head and Neck Squamous Cell Carcinoma
Keywords: SCCHN, head and neck, oropharyngeal, oral cavity, hypopharyngeal, laryngeal cancer, immunotherapy, PD-1, B7-H3, Lymphocyte Activation Gene-3 (LAG-3)
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Enrollment into each cohort will occur independently in a non-randomized fashion, based on PD-L1 expression results. Patients may not crossover between cohorts.
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 80 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Efficacy of enoblituzumab plus retifanlimab
[ Time Frame: 28 months ]

Investigator-assessed objective response rate (complete response [CR] or partial response [PR])
2. Safety of enoblituzumab plus tebotelimab
[ Time Frame: 30 days after last dose ]

Incidence of treatment-emergent adverse events
3. Efficacy of enoblituzumab plus tebotelimab
[ Time Frame: 28 months ]

Investigator-assessed objective response rate
Secondary Outcome Measures:
1. Progression-free survival
[ Time Frame: 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
[ Time Frame: 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
[ Time Frame: 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
[ Time Frame: 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
[ Time Frame: 30 days after last dose ]

Incidence of treatment-emergent adverse events
6. Pharmacokinetics of enoblituzumab plus retifanlimab
[ Time Frame: up to 42 weeks ]

Serum concentration of enoblituzumab and retifanlimab
7. Pharmacokinetics of enoblituzumab plus tebotelimab
[ Time Frame: up to 42 weeks ]

Serum concentration of enoblituzumab and tebotelimab
8. Immunogenicity of enoblituzumab plus retifanlimab
[ Time Frame: 28 months ]

Proportion of patients who develop anti-drug antibodies
9. Immunogenicity of enoblituzumab plus tebotelimab
[ Time Frame: 28 months ]

Proportion of patients who develop anti-drug antibodies
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Susan Brann
Telephone: (240) 552-8023
Email: branns@macrogenics.com
Central Contact Backup: Michelle Diggs
Telephone: (240) 552-8048
Email: diggsm@macrogenics.com
Study Officials: Fernanda Arnaldez, MD
Study Director
MacroGenics
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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