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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04634825
Ethics application status
Date submitted
12/11/2020
Date registered
18/11/2020

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
Treatment: Other - Enoblituzumab
Treatment: Other - Retifanlimab
Treatment: Other - 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


Treatment: Other: Enoblituzumab
Anti-B7-H3 antibody

Treatment: Other: Retifanlimab
Anti-PD-1 antibody

Treatment: Other: Tebotelimab
PD-1 X LAG-3 bispecific DART molecule
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab
Timepoint [1] 0 0
Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months.
Primary outcome [2] 0 0
Number of Patients With Adverse Events (AEs) Receiving Enoblituzumab Plus Tebotelimab
Timepoint [2] 0 0
Throughout the study, up to 16.5 months.
Primary outcome [3] 0 0
ORR of Enoblituzumab Plus Tebotelimab
Timepoint [3] 0 0
Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
Secondary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
Secondary outcome [2] 0 0
Disease-control Rate (DCR)
Timepoint [2] 0 0
Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
up to 16.5 months
Secondary outcome [5] 0 0
Best Overall Response (BOR)
Timepoint [5] 0 0
Tumor assessment is conducted 6 weeks after first dose, then every 9 weeks until disease progression, up to 16.5 months
Secondary outcome [6] 0 0
Number of Patients With AEs Receiving Enoblituzumab Plus Retifanlimab
Timepoint [6] 0 0
Throughout the study, up to 16.5 months.
Secondary outcome [7] 0 0
Maximum Drug Concentration or Drug Concentration of Enoblituzumab at the End of Infusion of Enoblituzumab (Cmax)
Timepoint [7] 0 0
Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [2 hours]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days)
Secondary outcome [8] 0 0
Maximum Drug Concentration or Drug Concentration of Tebotelimab at the End of Infusion of Tebotelimab (Cmax)
Timepoint [8] 0 0
Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days)
Secondary outcome [9] 0 0
Maximum Drug Concentration or Drug Concentration of Retifanlimab at the End of Infusion of Enoblituzumab (Cmax)
Timepoint [9] 0 0
Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days)
Secondary outcome [10] 0 0
Trough Concentration of Enoblituzumab (Ctrough or Cmin)
Timepoint [10] 0 0
Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [2 hours]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days
Secondary outcome [11] 0 0
Trough Concentration of Tebotelimab (Ctrough or Cmin)
Timepoint [11] 0 0
Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days)
Secondary outcome [12] 0 0
Trough Concentration of Retifanlimab (Ctrough or Cmin)
Timepoint [12] 0 0
Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days)
Secondary outcome [13] 0 0
Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab.
Timepoint [13] 0 0
Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
Secondary outcome [14] 0 0
Number of Patients Who Develop ADA to Tebotelimab
Timepoint [14] 0 0
Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
Secondary outcome [15] 0 0
Number of Patients Who ADA to Retifanlimab
Timepoint [15] 0 0
Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/07/2022
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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 hospital [7] 0 0
Fiona Stanley Hospital - Murdoch
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 postcode(s) [7] 0 0
6150 - Murdoch
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
Szekszard
Country [14] 0 0
Poland
State/province [14] 0 0
Bialystok
Country [15] 0 0
Poland
State/province [15] 0 0
Gdansk
Country [16] 0 0
Poland
State/province [16] 0 0
Gliwice
Country [17] 0 0
Poland
State/province [17] 0 0
Jozefow
Country [18] 0 0
Poland
State/province [18] 0 0
Warszawa
Country [19] 0 0
Spain
State/province [19] 0 0
Badajoz
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
Pamplona
Country [23] 0 0
Spain
State/province [23] 0 0
Sevilla
Country [24] 0 0
Ukraine
State/province [24] 0 0
Dnipro
Country [25] 0 0
Ukraine
State/province [25] 0 0
Kharkiv
Country [26] 0 0
Ukraine
State/province [26] 0 0
Kropyvnytskyi
Country [27] 0 0
Ukraine
State/province [27] 0 0
Kyiv
Country [28] 0 0
Ukraine
State/province [28] 0 0
Sumy
Country [29] 0 0
Ukraine
State/province [29] 0 0
Vinnytsia

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ashley L. Ward, MD
Address 0 0
MacroGenics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04634825