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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04634825
Registration number
NCT04634825
Ethics application status
Date submitted
12/11/2020
Date registered
18/11/2020
Date last updated
20/12/2023
Titles & IDs
Public title
Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
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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
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Secondary ID [1]
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CP-MGA271-06
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer
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Head and Neck Neoplasms
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Head and Neck Squamous Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Head and neck
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab
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Assessment method [1]
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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
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Timepoint [1]
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Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months.
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Primary outcome [2]
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Number of Patients With Adverse Events (AEs) Receiving Enoblituzumab Plus Tebotelimab
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Assessment method [2]
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Timepoint [2]
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Throughout the study, up to 16.5 months.
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Primary outcome [3]
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ORR of Enoblituzumab Plus Tebotelimab
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Assessment method [3]
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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
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Timepoint [3]
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Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
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Secondary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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Time from the first dose date to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort
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Timepoint [1]
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Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
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Secondary outcome [2]
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Disease-control Rate (DCR)
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Assessment method [2]
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Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort
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Timepoint [2]
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Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
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Secondary outcome [3]
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Duration of Response
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Assessment method [3]
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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
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Timepoint [3]
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Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Time from the first dose date to the date of death from any cause, evaluated by cohort
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Timepoint [4]
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up to 16.5 months
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Secondary outcome [5]
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Best Overall Response (BOR)
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Assessment method [5]
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The participants best response to treatment during their study participation. Responses are categorized as CR, PR, stable disease (SD), progressive disease (PD), or not evaluated (NE), per RECIST 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, and non-PD in non-target lesions PD is defined as at least a 20% increase from nadir in the sum of diameters of target lesions or unequivocal progression in non-target lesions SD is defined as non-PD in target and non-target lesions
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Timepoint [5]
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Tumor assessment is conducted 6 weeks after first dose, then every 9 weeks until disease progression, up to 16.5 months
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Secondary outcome [6]
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Number of Patients With AEs Receiving Enoblituzumab Plus Retifanlimab
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Assessment method [6]
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Timepoint [6]
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Throughout the study, up to 16.5 months.
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Secondary outcome [7]
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Maximum Drug Concentration or Drug Concentration of Enoblituzumab at the End of Infusion of Enoblituzumab (Cmax)
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Assessment method [7]
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The highest measured concentration of enoblituzumab in the bloodstream.
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Timepoint [7]
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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)
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Secondary outcome [8]
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Maximum Drug Concentration or Drug Concentration of Tebotelimab at the End of Infusion of Tebotelimab (Cmax)
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Assessment method [8]
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The highest measured concentration of tebotelimab in the bloodstream.
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Timepoint [8]
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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)
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Secondary outcome [9]
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Maximum Drug Concentration or Drug Concentration of Retifanlimab at the End of Infusion of Enoblituzumab (Cmax)
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Assessment method [9]
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The highest measured concentration of retifanlimab in the bloodstream.
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Timepoint [9]
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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)
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Secondary outcome [10]
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Trough Concentration of Enoblituzumab (Ctrough or Cmin)
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Assessment method [10]
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The amount of enoblituzumab left in the bloodstream before the next dose is given.
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Timepoint [10]
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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
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Secondary outcome [11]
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Trough Concentration of Tebotelimab (Ctrough or Cmin)
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Assessment method [11]
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The amount of tebotelimab left in the bloodstream before the next dose is given.
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Timepoint [11]
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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)
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Secondary outcome [12]
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Trough Concentration of Retifanlimab (Ctrough or Cmin)
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Assessment method [12]
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The amount of retifanlimab left in the bloodstream before the next dose is given.
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Timepoint [12]
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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)
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Secondary outcome [13]
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Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab.
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Assessment method [13]
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Timepoint [13]
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Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
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Secondary outcome [14]
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Number of Patients Who Develop ADA to Tebotelimab
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Assessment method [14]
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Timepoint [14]
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Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
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Secondary outcome [15]
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Number of Patients Who ADA to Retifanlimab
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Assessment method [15]
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Timepoint [15]
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Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/07/2022
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Sample size
Target
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Accrual to date
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Final
62
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Monash Health, Medical Oncology Department - Ruse
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Recruitment hospital [3]
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Royal North Shore Hospital - Sydney
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Recruitment hospital [4]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [5]
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Icon Cancer Centre Southport - Southport
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Recruitment hospital [6]
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Andrew Love Cancer Centre, Barwon Health - Geelong
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Recruitment hospital [7]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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3168 - Ruse
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Recruitment postcode(s) [3]
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2065 - Sydney
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Recruitment postcode(s) [4]
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2298 - Waratah
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Recruitment postcode(s) [5]
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4215 - Southport
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Recruitment postcode(s) [6]
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3220 - Geelong
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Recruitment postcode(s) [7]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Maryland
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Country [2]
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United States of America
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State/province [2]
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Michigan
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United States of America
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State/province [3]
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Nevada
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Country [4]
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United States of America
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State/province [4]
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North Carolina
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Country [5]
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United States of America
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State/province [5]
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Pennsylvania
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Country [6]
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Bulgaria
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State/province [6]
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Dobrich
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Country [7]
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Bulgaria
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State/province [7]
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Panagyurishte
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Country [8]
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Bulgaria
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State/province [8]
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Pleven
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Country [9]
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Bulgaria
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State/province [9]
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Sofia
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Country [10]
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Hungary
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State/province [10]
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Budapest
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Country [11]
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Hungary
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State/province [11]
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Debrecen
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Country [12]
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Hungary
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State/province [12]
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Gyula
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Country [13]
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Hungary
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State/province [13]
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Szekszard
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Country [14]
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Poland
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State/province [14]
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Bialystok
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Country [15]
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Poland
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State/province [15]
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Gdansk
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Poland
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State/province [16]
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Gliwice
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Poland
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State/province [17]
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Jozefow
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Country [18]
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Poland
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State/province [18]
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Warszawa
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Country [19]
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Spain
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State/province [19]
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Badajoz
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Country [20]
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Spain
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State/province [20]
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Barcelona
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Country [21]
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Spain
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State/province [21]
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Madrid
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Country [22]
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Spain
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State/province [22]
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Pamplona
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Country [23]
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Spain
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State/province [23]
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Sevilla
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Country [24]
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Ukraine
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State/province [24]
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Dnipro
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Country [25]
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Ukraine
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State/province [25]
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Kharkiv
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Country [26]
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Ukraine
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State/province [26]
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Kropyvnytskyi
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Country [27]
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Ukraine
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State/province [27]
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Kyiv
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Country [28]
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Ukraine
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State/province [28]
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Sumy
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Country [29]
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Ukraine
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State/province [29]
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Vinnytsia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
MacroGenics
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04634825
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ashley L. Ward, MD
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Address
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MacroGenics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04634825
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