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Based on internal review of safety data
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retifanlimab Cohort | Experimental | Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles |
|
| Tebotelimab Cohort | Experimental | Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoblituzumab | Biological | Anti-B7-H3 antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
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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
Results available from human papilloma virus p16 status for oropharyngeal cancer
Acceptable laboratory results
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley L. Ward, MD | MacroGenics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Retifanlimab Cohort | Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles |
| FG001 | Tebotelimab Cohort | Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2020 | May 30, 2023 |
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Enrollment into each cohort will occur independently in a non-randomized fashion, based on PD-L1 expression results. Patients may not crossover between cohorts.
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| Retifanlimab | Biological | Anti-PD-1 antibody |
|
|
| Tebotelimab | Biological | PD-1 X LAG-3 bispecific DART molecule |
|
|
Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort |
| 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months |
| University of Michigan |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| University of North Carolina - Lineberger Cancer Center | Chapel Hill | North Carolina | 27514 | United States |
| University of Pennsylvania - Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center- Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Monash Health, Medical Oncology Department | Ruse | New South Wales | 3168 | Australia |
| Royal North Shore Hospital | Sydney | New South Wales | 2065 | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| Icon Cancer Centre Southport | Southport | Queensland | 4215 | Australia |
| Andrew Love Cancer Centre, Barwon Health | Geelong | Victoria | 3220 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| Complex Oncology Center Ruse Ltd. | Dobrich | 7002 | Bulgaria |
| MHAT Serdica | Panagyurishte | 1632 | Bulgaria |
| MBAL Uni Hospital | Pleven | 4500 | Bulgaria |
| MHAT Nadezhda, Medical Oncology | Sofia | 1373 | Bulgaria |
| UMHAT Tsarisa Yoanna - ISUL | Sofia | 1527 | Bulgaria |
| UMHAT Georgi Stranski Medical Oncology Department | Sofia | 5800 | Bulgaria |
| COC Dobrich | Sofia | 9300 | Bulgaria |
| Bajcsy-Zsilinszky Korhaz | Budapest | 01106 | Hungary |
| Uzsoki Street Hospital | Budapest | 1145 | Hungary |
| Dept of Oncology, University of Debrecen | Debrecen | 04032 | Hungary |
| Dept of Oncology, Bekec County Hosp | Gyula | 5700 | Hungary |
| Dept of Oncology, Tolna County Hospital | Szekszárd | 7100 | Hungary |
| The Ewa Pilecka Department of Clinical Oncology | Bialystok | 15027 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| I Clinics of Radiotherapy and Chemiotherapy; The Maria Sklodowska-Curie National Research Institute of Oncology | Gliwice | 44-102 | Poland |
| Biokinetica | Józefów | 05-410 | Poland |
| Clinics of Head and Neck Cancer, The Maria Sklodowska-Curie National Research Institute of Oncology | Warsaw | Poland |
| Complejo Hospitalario Universitario de Badajoz | Badajoz | 06080 | Spain |
| Hospital Universitario Vall D'Hebrón | Barcelona | 08035 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Clinica Universidad de Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario Virgen de la Macarena | Seville | 41009 | Spain |
| Communal Non-profit Enterprise "City Clinical Hospital#4" of Dnipro City | Dnipro | 49102 | Ukraine |
| Communal Non-Profit Enterprise "Regional Center of Oncology", Oncosurgical Department of Head and Neck | Kharkiv | 61070 | Ukraine |
| Communal Non-profit Enterprise "Regional Clinical Oncology Center of Kirovohrad Regional Council", | Kropyvnytskyi | 25000 | Ukraine |
| Kyiv City Clinical Oncological Centre | Kyiv | 03115 | Ukraine |
| Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Dispensary" | Sumy | 40022 | Ukraine |
| Communal Nonprofit Enterprise Podilsky Regional Center of Oncology | Vinnytsia | 21029 | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Retifanlimab Cohort | Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks |
| BG001 | Tebotelimab Cohort | Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months. |
|
|
| |||||||||||||||||||||||||||
| Primary | Number of Patients With Adverse Events (AEs) Receiving Enoblituzumab Plus Tebotelimab | Posted | Count of Participants | Participants | Throughout the study, up to 16.5 months. |
|
|
| ||||||||||||||||||||||||||||
| Primary | 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 | Posted | Count of Participants | Participants | Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Median | 95% Confidence Interval | months | Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months |
|
| |||||||||||||||||||||||||||
| Secondary | Disease-control Rate (DCR) | Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort | Posted | Count of Participants | Participants | Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Mean | Standard Deviation | months | Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | Time from the first dose date to the date of death from any cause, evaluated by cohort | Posted | Median | 95% Confidence Interval | months | up to 16.5 months |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | Tumor assessment is conducted 6 weeks after first dose, then every 9 weeks until disease progression, up to 16.5 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients With AEs Receiving Enoblituzumab Plus Retifanlimab | Posted | Count of Participants | Participants | Throughout the study, up to 16.5 months. |
|
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Participants who received Enoblituzumab and had at least 1 end of infusion PK sample. As pre-specified in the PK analysis plan, Enoblituzumab PK data from both arms of the study were combined for analysis since Enoblituzumab dose was schedule were consistent across both arms. | Posted | Mean | Standard Deviation | mcg/mL | 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 | 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. | Participants who received tebotelimab and had at least 1 End of Infusion PK sample | Posted | Mean | Standard Deviation | mcg/mL | 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 | 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. | Participants who received retifanlimab and had at least 1 end of infusion PK sample. | Posted | Mean | Standard Deviation | mcg/mL | 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 | Trough Concentration of Enoblituzumab (Ctrough or Cmin) | The amount of enoblituzumab left in the bloodstream before the next dose is given. | Participants who received enoblituzumab and had at least 1 pre-infusion PK sample. As pre-specified in the PK analysis plan, enoblituzumab PK data from both arms of the study were combined for analysis since enoblituzumab dose and schedule were consistent across both arms. | Posted | Mean | Standard Deviation | mcg/mL | 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 | Trough Concentration of Tebotelimab (Ctrough or Cmin) | The amount of tebotelimab left in the bloodstream before the next dose is given. | Participants who received tebotelimab and had at least 1 pre-infusion PK sample. | Posted | Mean | Standard Deviation | mcg/mL | 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 | Trough Concentration of Retifanlimab (Ctrough or Cmin) | The amount of retifanlimab left in the bloodstream before the next dose is given. | Participants who received retifanlimab and had at least 1 pre-infusion PK sample. | Posted | Mean | Standard Deviation | mcg/mL | 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 | Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. | As pre-specified in the PK analysis plan, enoblituzumab ADA data from both arms of the study were combined for analysis since enoblituzumab dose and schedule were consistent across both arms. | Posted | Count of Participants | Participants | Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Develop ADA to Tebotelimab | Only participants receiving tebotelimab were analyzed for the presence of tebotelimab ADA. | Posted | Count of Participants | Participants | Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients Who ADA to Retifanlimab | Only participants receiving retifanlimab were analyzed for the presence of retifanlimab ADA. | Posted | Count of Participants | Participants | Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months |
|
|
Throughout the study, up to 16.5 months
AEs are based on physical exam, participant reports and significant abnormal laboratory values.
AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator..
Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Retifanlimab Cohort | Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks | 10 | 48 | 14 | 48 | 40 | 48 |
| EG001 | Tebotelimab Cohort | Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks | 3 | 14 | 6 | 14 | 12 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiotoxicity | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tracheo-oesophageal fistula | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Immune-mediated endocrinopathy | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cytomegalovirus gastritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fungating wound | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrostomy | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Swollen tongue | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Inadequate analgesia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Breakthrough COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastroenteritis staphylococcal | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gingival abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tracheostomy infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Incision site ulcer | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| N-terminal prohormone brain natriuretic peptide increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Coronavirus test positive | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypouricaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Steroid diabetes | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acrochordon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tracheal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | MacroGenics, Inc. | 301-251-5172 | info@macrogenics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2021 | May 12, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Ukraine |
|
| Poland |
|
| Bulgaria |
|
| Australia |
|
| Spain |
|
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