Head and Neck CancerPhase 2NCT04634825
Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
A Phase 2 study testing Enoblituzumab, Retifanlimab and Tebotelimab in people with Head and Neck Cancer and Head and Neck Neoplasms, run by MacroGenics at 42 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Enoblituzumab, Retifanlimab and Tebotelimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 42 sitesin 7 countries
- Study dates
- 17 Mar 2021to 29 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
42 sites in 7 countries.
42 sites in 7 countries
Australia7 sites
Andrew Love Cancer Centre, Barwon Health
Geelong, Victoria, 3220
Liverpool Hospital
Liverpool, New South Wales, 2170
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Monash Health, Medical Oncology Department
Ruse, New South Wales, 3168
Icon Cancer Centre Southport
Southport, Queensland, 4215
Royal North Shore Hospital
Sydney, New South Wales, 2065
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Bulgaria7 sites
Complex Oncology Center Ruse Ltd.
Dobrich, 7002
MHAT Serdica
Panagyurishte, 1632
MBAL Uni Hospital
Pleven, 4500
MHAT Nadezhda, Medical Oncology
Sofia, 1373
UMHAT Tsarisa Yoanna - ISUL
Sofia, 1527
UMHAT Georgi Stranski Medical Oncology Department
Sofia, 5800
COC Dobrich
Sofia, 9300
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
University of North Carolina - Lineberger Cancer Center
Chapel Hill, North Carolina, 27514
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center- Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Spain6 sites
Complejo Hospitalario Universitario de Badajoz
Badajoz, 06080
Hospital Universitario Vall D'Hebrón
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Clínico San Carlos
Madrid, 28040
Clinica Universidad de Navarra
Pamplona, 31008
Hospital Universitario Virgen de la Macarena
Seville, 41009
Ukraine6 sites
Communal Non-profit Enterprise "City Clinical Hospital#4" of Dnipro City
Dnipro, 49102
Communal Non-Profit Enterprise "Regional Center of Oncology", Oncosurgical Department of Head and Neck
Kharkiv, 61070
Communal Non-profit Enterprise "Regional Clinical Oncology Center of Kirovohrad Regional Council",
Kropyvnytskyi, 25000
Kyiv City Clinical Oncological Centre
Kyiv, 03115
Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Dispensary"
Sumy, 40022
Communal Nonprofit Enterprise Podilsky Regional Center of Oncology
Vinnytsia, 21029
Hungary5 sites
Bajcsy-Zsilinszky Korhaz
Budapest, 01106
Uzsoki Street Hospital
Budapest, 1145
Dept of Oncology, University of Debrecen
Debrecen, 04032
Dept of Oncology, Bekec County Hosp
Gyula, 5700
Dept of Oncology, Tolna County Hospital
Szekszárd, 7100
Poland5 sites
The Ewa Pilecka Department of Clinical Oncology
Bialystok, 15027
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
I Clinics of Radiotherapy and Chemiotherapy; The Maria Sklodowska-Curie National Research Institute of Oncology
Gliwice, 44-102
Biokinetica
Józefów, 05-410
Clinics of Head and Neck Cancer, The Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw
About this study
Official 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
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.
- Being tested
- Enoblituzumab, Retifanlimab, Tebotelimab
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoblituzumabBiological
Also called MGA271
Anti-B7-H3 antibody
RetifanlimabBiological
Also called INCMGA00012, MGA012, Zynyz
Anti-PD-1 antibody
TebotelimabBiological
Also called MGD013
PD-1 X LAG-3 bispecific DART molecule
| Study group | Role | What they receive |
|---|---|---|
| Retifanlimab Cohort | Experimental | Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles Receives: 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 Receives: Biological: Enoblituzumab; Biological: Tebotelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Time from the first dose date to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort
Measured: 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)
Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort
Measured: 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
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
Measured: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
Overall Survival
Time from the first dose date to the date of death from any cause, evaluated by cohort
Measured: up to 16.5 months
Best Overall Response (BOR)
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
Measured: Tumor assessment is conducted 6 weeks after first dose, then every 9 weeks until disease progression, up to 16.5 months
Number of Patients With AEs Receiving Enoblituzumab Plus Retifanlimab
Measured: Throughout the study, up to 16.5 months.
Maximum Drug Concentration or Drug Concentration of Enoblituzumab at the End of Infusion of Enoblituzumab (Cmax)
The highest measured concentration of enoblituzumab in the bloodstream.
Measured: 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)
Maximum Drug Concentration or Drug Concentration of Tebotelimab at the End of Infusion of Tebotelimab (Cmax)
The highest measured concentration of tebotelimab in the bloodstream.
Measured: 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)
Maximum Drug Concentration or Drug Concentration of Retifanlimab at the End of Infusion of Enoblituzumab (Cmax)
The highest measured concentration of retifanlimab in the bloodstream.
Measured: 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)
Trough Concentration of Enoblituzumab (Ctrough or Cmin)
The amount of enoblituzumab left in the bloodstream before the next dose is given.
Measured: 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
Trough Concentration of Tebotelimab (Ctrough or Cmin)
The amount of tebotelimab left in the bloodstream before the next dose is given.
Measured: 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)
Trough Concentration of Retifanlimab (Ctrough or Cmin)
The amount of retifanlimab left in the bloodstream before the next dose is given.
Measured: 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)
Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab.
Measured: Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
Number of Patients Who Develop ADA to Tebotelimab
Measured: Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
Number of Patients Who ADA to Retifanlimab
Measured: Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start17 Mar 2021
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Why it stopped: Based on internal review of safety data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Enrollment into each cohort will occur independently in a non-randomized fashion, based on PD-L1 expression results. Patients may not crossover between cohorts.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashley L. Ward, MD, Study director, MacroGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634825
- Sponsor's protocol ID
- CP-MGA271-06
- Status last verified
- Dec 2023
- First submitted
- 12 Nov 2020
- Last updated
- 20 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04634825
- Acronym / sponsor ID
- CP-MGA271-06
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on internal review of safety data
- Enrolment
- 62 participants (actual)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrollment into each cohort will occur independently in a non-randomized fashion, based on PD-L1 expression results. Patients may not crossover between cohorts.
| Arm | Type | Receives |
|---|---|---|
| Retifanlimab Cohort | Experimental | Biological: Enoblituzumab, Biological: RetifanlimabEnoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles |
| Tebotelimab Cohort | Experimental | Biological: Enoblituzumab, Biological: TebotelimabEnoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnoblituzumabAlso: MGA271Anti-B7-H3 antibody | Biological | Retifanlimab Cohort, Tebotelimab Cohort |
| RetifanlimabAlso: INCMGA00012, MGA012, ZynyzAnti-PD-1 antibody | Biological | Retifanlimab Cohort |
| TebotelimabAlso: MGD013PD-1 X LAG-3 bispecific DART molecule | Biological | Tebotelimab Cohort |
Primary outcome
Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab
Time frame: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months.
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
Number of Patients With Adverse Events (AEs) Receiving Enoblituzumab Plus Tebotelimab
Time frame: Throughout the study, up to 16.5 months.
ORR of Enoblituzumab Plus Tebotelimab
Time frame: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
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
15 secondary outcomes
Progression-free Survival (PFS)
Time frame: 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)
Time frame: 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
Time frame: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
Overall Survival
Time frame: up to 16.5 months
Best Overall Response (BOR)
Time frame: Tumor assessment is conducted 6 weeks after first dose, then every 9 weeks until disease progression, up to 16.5 months
Number of Patients With AEs Receiving Enoblituzumab Plus Retifanlimab
Time frame: Throughout the study, up to 16.5 months.
Maximum Drug Concentration or Drug Concentration of Enoblituzumab at the End of Infusion of Enoblituzumab (Cmax)
Time frame: 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)
Maximum Drug Concentration or Drug Concentration of Tebotelimab at the End of Infusion of Tebotelimab (Cmax)
Time frame: 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)
Maximum Drug Concentration or Drug Concentration of Retifanlimab at the End of Infusion of Enoblituzumab (Cmax)
Time frame: 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)
Trough Concentration of Enoblituzumab (Ctrough or Cmin)
Time frame: 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
Trough Concentration of Tebotelimab (Ctrough or Cmin)
Time frame: 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)
Trough Concentration of Retifanlimab (Ctrough or Cmin)
Time frame: 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)
Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab.
Time frame: Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
Number of Patients Who Develop ADA to Tebotelimab
Time frame: Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
Number of Patients Who ADA to Retifanlimab
Time frame: Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley L. Ward, MD study director
MacroGenics
42 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enoblituzumab, Retifanlimab and Tebotelimab in people with Head and Neck Cancer and Head and Neck Neoplasms, run by MacroGenics at 42 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Australia, Bulgaria, United States, Spain, Ukraine and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab (time frame: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.