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Enoblituzumab Plus MGA012 in Squamous Cell Carcinoma of the Head and Neck

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ClinicalTrials.gov Identifier: NCT04129320
Recruitment Status : Not yet recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
MacroGenics

Brief Summary:
This is a Phase 2/3, randomized, open-label study designed to evaluate safety and efficacy of enoblituzumab in combination with MGA012, with and without chemotherapy, in first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The study will be conducted in 2 modules, Module A (Phase 2) and Module B (Phase 3).

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Squamous Cell Carcinoma of Head and Neck Biological: pembrolizumab Biological: enoblituzumab Biological: MGA012 Drug: Chemotherapeutic Combinations Phase 2 Phase 3

Detailed Description:
In Module A, approximately 200 patients will be randomized to 1 of 4 arms (approximately 50 patients each arm): pembrolizumab + chemotherapy, enoblituzumab + MGA012, enoblituzumab + MGA012 + chemotherapy, and MGA012 + chemotherapy. Data from the enoblituzumab + MGA012 arm and enoblituzumab + MGA012 + chemotherapy arm will be assessed to determine whether further evaluation of one of these arms in Module B is warranted. If one or more of the experimental arms demonstrates improved efficacy with acceptable safety compared to the pembrolizumab + chemotherapy arm, enrollment will be initiated in Module B with approximately 260 patients per arm (enoblituzumab + MGA012 with or without chemotherapy vs. pembrolizumab + chemotherapy).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2/3 Open-Label Trial to Evaluate Enoblituzumab in Combination With MGA012, With and Without Chemotherapy, in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025


Arm Intervention/treatment
Active Comparator: Control Arm
Pembrolizumab plus Chemotherapy
Biological: pembrolizumab
anti-PD-1 antibody
Other Name: Keytruda

Drug: Chemotherapeutic Combinations
carboplatin or cisplatin plus 5-fluorouracil (5-FU)

Experimental: Experimental Arm 1
Enoblituzumab plus MGA012
Biological: enoblituzumab
anti-B7-H3 antibody
Other Name: MGA271

Biological: MGA012
anti-PD-1 antibody
Other Name: INCMGA00012

Experimental: Experimental Arm 2
Enoblituzumab plus MGA012 plus Chemotherapy
Biological: enoblituzumab
anti-B7-H3 antibody
Other Name: MGA271

Biological: MGA012
anti-PD-1 antibody
Other Name: INCMGA00012

Drug: Chemotherapeutic Combinations
carboplatin or cisplatin plus 5-fluorouracil (5-FU)

Experimental: Experimental Arm 3
MGA012 plus Chemotherapy
Biological: MGA012
anti-PD-1 antibody
Other Name: INCMGA00012

Drug: Chemotherapeutic Combinations
carboplatin or cisplatin plus 5-fluorouracil (5-FU)




Primary Outcome Measures :
  1. Overall Response Rate - Module A [ Time Frame: 2 years ]
    Proportion of patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1

  2. Incidence of Adverse Events as assessed by CTCAE v 4.03 - Module A and B [ Time Frame: Up to 30 days after last dose of study drug ]
    Evaluation of adverse events and serious adverse events

  3. Overall Survival - Module A and B [ Time Frame: 2 years ]
    Time from randomization to death from any cause


Secondary Outcome Measures :
  1. Immunogenicity - Module A [ Time Frame: 2 years ]
    Percentage of patients developing anti-drug antibodies to enoblituzumab and/or MGA012

  2. Progression-free Survival - Module A and B [ Time Frame: 2 years ]
    Time from start of study treatment to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.

  3. Disease Control Rate - Module A and B [ Time Frame: 2 years ]
    Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment

  4. Duration of Response - Module A and B [ Time Frame: 2 years ]
    Time from the date of initial response to the date of first documented progression or death from any cause, whichever occurs first

  5. Quality of Life QLQ-C30 - Module B [ Time Frame: 2 years ]
    EORTC overall Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.

  6. Quality of Life H&N-35 - Module B [ Time Frame: 2 years ]
    EORTC Quality of Life questionnaire H&N-35 for head and neck cancer patients on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven, recurrent or metastatic 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 of given as part of multimodal treatment for locally advanced disease)
  • Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx
  • HPV test results available (positive and negative eligible)
  • ECOG Performance status of 0 or 1
  • Adequate end organ function

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 of randomization
  • Diagnosis of immunodeficiency, or use of immunosuppresive therapy within 14 days of first dose of study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129320


Contacts
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Contact: Susan Brann 240-552-8023 branns@macrogenics.com
Contact: Scott Currence 240-552-8081 currences@macrogenics.com

Sponsors and Collaborators
MacroGenics
Investigators
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Study Director: Fernanda I Arnaldez, MD MacroGenics

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Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT04129320     History of Changes
Other Study ID Numbers: CP-MGA271-05
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MacroGenics:
SCCHN
head and neck
oropharyngeal
oral cavity
hypopharyngeal
laryngeal cancer
immunotherapy
PD-1
B7-H3
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents