Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

NCT04634825 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CP-MGA271-06
• Study Type: interventional
• Target: 62
• Locations: 7 countries
• Sites: 42

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.

Conditions

Head and Neck Cancer; Head and Neck Neoplasms; Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab

  Investigator-assessed ORR. defined as the percentage of patients in the response evaluable population who achieve the best overall response of complete response (CR) or partial response (PR),per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria.. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions

  Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months.

• Number of Patients With Adverse Events (AEs) Receiving Enoblituzumab Plus Tebotelimab

  Throughout the study, up to 16.5 months.

• ORR of Enoblituzumab Plus Tebotelimab

  Investigator-assessed ORR. ORR, defined as the percentage of patients in the response evaluable population who achieve the a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions

  Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months

Secondary Outcomes (15)

• Progression-free Survival (PFS)

  Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months

• Disease-control Rate (DCR)

  Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months

• Duration of Response

  Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months

• Overall Survival

  up to 16.5 months

• Best Overall Response (BOR)

  Tumor assessment is conducted 6 weeks after first dose, then every 9 weeks until disease progression, up to 16.5 months

Study Arms (2)

Retifanlimab Cohort

EXPERIMENTAL

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

Biological: Enoblituzumab; Biological: Retifanlimab

Tebotelimab Cohort

EXPERIMENTAL

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

Biological: Enoblituzumab; Biological: Tebotelimab

Interventions

Enoblituzumab BIOLOGICAL

Anti-B7-H3 antibody

Also known as: MGA271

Retifanlimab Cohort; Tebotelimab Cohort

Retifanlimab BIOLOGICAL

Anti-PD-1 antibody

Also known as: INCMGA00012, MGA012, Zynyz

Retifanlimab Cohort

Tebotelimab BIOLOGICAL

PD-1 X LAG-3 bispecific DART molecule

Also known as: MGD013

Tebotelimab Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• MacroGenics: lead

Study Sites (42)

University of Maryland, Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

University of North Carolina - Lineberger Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

University of Pennsylvania - Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center- Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Monash Health, Medical Oncology Department

Ruse, New South Wales, 3168, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

Location

Icon Cancer Centre Southport

Southport, Queensland, 4215, Australia

Location

Andrew Love Cancer Centre, Barwon Health

Geelong, Victoria, 3220, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Complex Oncology Center Ruse Ltd.

Dobrich, 7002, Bulgaria

Location

MHAT Serdica

Panagyurishte, 1632, Bulgaria

Location

MBAL Uni Hospital

Pleven, 4500, Bulgaria

Location

MHAT Nadezhda, Medical Oncology

Sofia, 1373, Bulgaria

Location

UMHAT Tsarisa Yoanna - ISUL

Sofia, 1527, Bulgaria

Location

UMHAT Georgi Stranski Medical Oncology Department

Sofia, 5800, Bulgaria

Location

COC Dobrich

Sofia, 9300, Bulgaria

Location

Bajcsy-Zsilinszky Korhaz

Budapest, 01106, Hungary

Location

Uzsoki Street Hospital

Budapest, 1145, Hungary

Location

Dept of Oncology, University of Debrecen

Debrecen, 04032, Hungary

Location

Dept of Oncology, Bekec County Hosp

Gyula, 5700, Hungary

Location

Dept of Oncology, Tolna County Hospital

Szekszárd, 7100, Hungary

Location

The Ewa Pilecka Department of Clinical Oncology

Bialystok, 15027, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Location

I Clinics of Radiotherapy and Chemiotherapy; The Maria Sklodowska-Curie National Research Institute of Oncology

Gliwice, 44-102, Poland

Location

Biokinetica

Józefów, 05-410, Poland

Location

Clinics of Head and Neck Cancer, The Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Poland

Location

Complejo Hospitalario Universitario de Badajoz

Badajoz, 06080, Spain

Location

Hospital Universitario Vall D'Hebrón

Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, 41009, Spain

Location

Communal Non-profit Enterprise "City Clinical Hospital#4" of Dnipro City

Dnipro, 49102, Ukraine

Location

Communal Non-Profit Enterprise "Regional Center of Oncology", Oncosurgical Department of Head and Neck

Kharkiv, 61070, Ukraine

Location

Communal Non-profit Enterprise "Regional Clinical Oncology Center of Kirovohrad Regional Council",

Kropyvnytskyi, 25000, Ukraine

Location

Kyiv City Clinical Oncological Centre

Kyiv, 03115, Ukraine

Location

Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Dispensary"

Sumy, 40022, Ukraine

Location

Communal Nonprofit Enterprise Podilsky Regional Center of Oncology

Vinnytsia, 21029, Ukraine

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Chief Medical Officer
• Organization: MacroGenics, Inc.

info@macrogenics.com

301-251-5172

Study Officials

• Ashley L. Ward, MD

  MacroGenics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Enrollment into each cohort will occur independently in a non-randomized fashion, based on PD-L1 expression results. Patients may not crossover between cohorts.

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start: March 17, 2021
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); UA (6); ES (6); HU (5); BU (7); AU (7); PL (5)