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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04634825




Registration number
NCT04634825
Ethics application status
Date submitted
12/11/2020
Date registered
18/11/2020
Date last updated
12/10/2021

Titles & IDs
Public title
Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
Scientific 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 ID [1] 0 0
CP-MGA271-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Head and Neck Neoplasms 0 0
Head and Neck Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Enoblituzumab
Other interventions - Retifanlimab
Other interventions - Tebotelimab

Experimental: Retifanlimab Cohort - Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles

Experimental: Tebotelimab Cohort - Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles


Other interventions: Enoblituzumab
Anti-B7-H3 antibody

Other interventions: Retifanlimab
Anti-PD-1 antibody

Other interventions: Tebotelimab
PD-1 X LAG-3 bispecific DART molecule

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of enoblituzumab plus retifanlimab - Investigator-assessed objective response rate (complete response [CR] or partial response [PR])
Timepoint [1] 0 0
28 months
Primary outcome [2] 0 0
Safety of enoblituzumab plus tebotelimab - Incidence of treatment-emergent adverse events
Timepoint [2] 0 0
30 days after last dose
Primary outcome [3] 0 0
Efficacy of enoblituzumab plus tebotelimab - Investigator-assessed objective response rate
Timepoint [3] 0 0
28 months
Secondary outcome [1] 0 0
Progression-free survival - Time from the first dose date to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort
Timepoint [1] 0 0
28 months
Secondary outcome [2] 0 0
Disease-control rate - Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort
Timepoint [2] 0 0
28 months
Secondary outcome [3] 0 0
Duration of response - 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
Timepoint [3] 0 0
28 months
Secondary outcome [4] 0 0
Overall survival - Time from the first dose date to the date of death from any cause, evaluated by cohort
Timepoint [4] 0 0
28 months
Secondary outcome [5] 0 0
Safety of enoblituzumab plus retifanlimab - Incidence of treatment-emergent adverse events
Timepoint [5] 0 0
30 days after last dose
Secondary outcome [6] 0 0
Pharmacokinetics of enoblituzumab plus retifanlimab - Serum concentration of enoblituzumab and retifanlimab
Timepoint [6] 0 0
up to 42 weeks
Secondary outcome [7] 0 0
Pharmacokinetics of enoblituzumab plus tebotelimab - Serum concentration of enoblituzumab and tebotelimab
Timepoint [7] 0 0
up to 42 weeks
Secondary outcome [8] 0 0
Immunogenicity of enoblituzumab or retifanlimab - Proportion of patients who develop anti-drug antibodies to enoblituzumab or retifanlimab
Timepoint [8] 0 0
28 months
Secondary outcome [9] 0 0
Immunogenicity of enoblituzumab or tebotelimab - Proportion of patients who develop anti-drug antibodies to enoblituzumab or tebotelimab.
Timepoint [9] 0 0
28 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Monash Health, Medical Oncology Department - Ruse
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [4] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [5] 0 0
Icon Cancer Centre Southport - Southport
Recruitment hospital [6] 0 0
Andrew Love Cancer Centre, Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3168 - Ruse
Recruitment postcode(s) [3] 0 0
2065 - Sydney
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Nevada
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Dobrich
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Panagyurishte
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Pleven
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Sofia
Country [10] 0 0
Hungary
State/province [10] 0 0
Budapest
Country [11] 0 0
Hungary
State/province [11] 0 0
Debrecen
Country [12] 0 0
Hungary
State/province [12] 0 0
Gyula
Country [13] 0 0
Hungary
State/province [13] 0 0
Szeged
Country [14] 0 0
Hungary
State/province [14] 0 0
Szekszard
Country [15] 0 0
Poland
State/province [15] 0 0
Bialystok
Country [16] 0 0
Poland
State/province [16] 0 0
Gdansk
Country [17] 0 0
Poland
State/province [17] 0 0
Gliwice
Country [18] 0 0
Poland
State/province [18] 0 0
Jozefow
Country [19] 0 0
Poland
State/province [19] 0 0
Warszawa
Country [20] 0 0
Spain
State/province [20] 0 0
Badajoz
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid
Country [23] 0 0
Spain
State/province [23] 0 0
Pamplona
Country [24] 0 0
Spain
State/province [24] 0 0
Sevilla
Country [25] 0 0
Ukraine
State/province [25] 0 0
Dnipro
Country [26] 0 0
Ukraine
State/province [26] 0 0
Kharkiv
Country [27] 0 0
Ukraine
State/province [27] 0 0
Kropyvnytskyi
Country [28] 0 0
Ukraine
State/province [28] 0 0
Kyiv
Country [29] 0 0
Ukraine
State/province [29] 0 0
Sumy
Country [30] 0 0
Ukraine
State/province [30] 0 0
Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MacroGenics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04634825
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chet Bohac, MD PharmD MSc
Address 0 0
MacroGenics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Susan Brann
Address 0 0
Country 0 0
Phone 0 0
(240) 552-8023
Fax 0 0
Email 0 0
branns@macrogenics.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04634825