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| ID | Type | Description | Link |
|---|---|---|---|
| EAR-17-12765 | Other Grant/Funding Number | AstraZeneca Pharmaceuticals |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. Participants will receive both durvalumab and cetuximab.
This research study is designed to see if the study drug, durvalumab, will work better with cetuximab than either medicine alone along with the evaluation of side effects of the drug combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Durvalumab and Cetuximab | Experimental | Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Two hour infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | RECIST 1.1 was assessed for each participant every 8 weeks from study initiation until the end of study treatment. The time from first RECIST 1.1 assessment to the final at the end of study was 8.5 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Related Adverse Events | Percentage of adverse events that were treatment related and greater than or equal to Grade 3 using CTCAE v 5.0. Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab). | From informed consent through study treatment and the 90-day safety follow-up period after the last dose of durvalumab and cetuximab, approximately 24.5 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuchi Gulati, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Health | Cincinnati | Ohio | 45219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Durvalumab and Cetuximab | Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance Durvalumab: Two hour infusion Cetuximab: Two hour infusion for loading dose followed by weekly one hour infusion |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2022 |
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| Cetuximab | Drug | Two hour infusion for loading dose followed by weekly one hour infusion |
|
| Disease Control Rate | Combined complete response, partial response, and stable disease | 6 months |
| Progression-free Survival | Imaging review using RECIST 1.1 Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | 24 months |
| Overall Survival | Date of on treatment to date of death | 24 months |
| COMPLETED |
|
| NOT COMPLETED |
|
Between October 2018 and October 2021, 35 patients were enrolled, of whom 33 received at least 1 dose of durvalumab and were included in response analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Durvalumab and Cetuximab | Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance Durvalumab: Two hour infusion Cetuximab: Two hour infusion for loading dose followed by weekly one hour infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | 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 |
| ||||||||||||||||||
| ECOG Status | The ECOG (Eastern Cooperative Oncology Group) Performance Status is a 0-5 scale used by clinicians to assess a cancer patient's functional level and ability to tolerate therapies, such as chemotherapy. It assists in determining appropriate treatment, prognosis, and quality of life. | Count of Participants | 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 | Objective Response Rate | Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Population included participants that had at least one dose of durvalumab. | Posted | Count of Participants | Participants | RECIST 1.1 was assessed for each participant every 8 weeks from study initiation until the end of study treatment. The time from first RECIST 1.1 assessment to the final at the end of study was 8.5 months. |
|
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Related Adverse Events | Percentage of adverse events that were treatment related and greater than or equal to Grade 3 using CTCAE v 5.0. Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab). | Posted | Number | percentage of all adverse events | From informed consent through study treatment and the 90-day safety follow-up period after the last dose of durvalumab and cetuximab, approximately 24.5 months. | Number of adverse events | Number of adverse events |
|
| ||||||||||||||||||||||||||
| Secondary | Disease Control Rate | Combined complete response, partial response, and stable disease | Subjects received at least one dose of Durvalumab. | Posted | Count of Participants | Participants | 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Imaging review using RECIST 1.1 Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | Posted | Median | 95% Confidence Interval | months | 24 months |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | Date of on treatment to date of death | Posted | Median | 95% Confidence Interval | months | 24 months |
|
|
Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months).
Our system does not differ from ct.gov.
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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 | Durvalumab and Cetuximab | Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance Durvalumab: Two hour infusion Cetuximab: Two hour infusion for loading dose followed by weekly one hour infusion | 1 | 35 | 24 | 35 | 35 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Diabetes mellitus type 1 | Endocrine disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Endocrine disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Eye chemosis/inflammation | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Colonic hemorrhage | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hematemesis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Oral cavity fistula | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Surgical site infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Tracheal obstruction | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Tracheostomy site bleeding | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Aspiration | Reproductive system and breast disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| HCAP/aspiration pneumonia with acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Lung Infection/Pneumonia | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Cervical adenopathy | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Macrocytic Anemia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Cyanosis | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Ear drainage | Ear and labyrinth disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Ear fullness | Ear and labyrinth disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Ear inflammation | Ear and labyrinth disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Diabetes mellitus type 1 | Endocrine disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Endocrine disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Eye chemosis, orbital apex inflammation extending into Cavernous sinus | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Eye discharge | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Eye Etropian | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Eye inflammation | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Eyelid function disorder | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fuzzy vision | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Itchy eyes | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Periorbital dermatitis | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Periorbital edema | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Scleral disorder | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Uveitis | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Vision decreased | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Chipped tooth | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Colonic hemorrhage | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Drooling | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Esophageal stenosis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Halitosis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hematemesis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Lip pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Melena | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Oral cavity fistula | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Oral dysesthesia | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Oral hemorrhage | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| PEG tub dislodge | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Throat closing | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Throat tightness | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Disease progression | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Facial inflammation | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Generalized edema | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Lips, tongue, gums inflammation | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Localized edema | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Neck edema | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Bladder infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Cheek abscess | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Cold sore | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| G tube infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Mouth sore | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| MRSA | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Redness at trach site | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Stoma site infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Surgical site infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Toe infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Abdomen tube leaking | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Arm wound | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Chin bleeding | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Discomfort at G-tube site | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Dislodged feeding tube | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Ear Wound | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| G tube erythema and drainage | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Gastrostomy tube leaking | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Irritation at G-tube site | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Leg wound | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Lip swelling from botox | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Bilateral shoulder bone spurs | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Buttocks wound | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| CVA tenderness | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Leg Cramps | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Neck stiffness | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Tumor drainage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
| |
| Tumor hemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Cranial nerve deficit | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Lightheadedness | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Panic attacks | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Bronchial stricture | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Chest congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| HCAP/aspiration pneumonia with acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Mucous plug | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pharyngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Thick secretions | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Tracheal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Brittle nails | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Erythema around PEG tube site | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Erythema-face | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Eyelash crusty | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Eyelashes falling out | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fingertips cracking/splitting/peeling | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Fissues | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Nail loss | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Neck edema | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Necrotic lesion | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pressure sore | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Skin breakdown | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Skin irritation around g-tube | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Mouth irritation | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Toenail pain | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Skin and Other Subcutaneous Tissue Disorders (Unknown) | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Esophagram | Surgical and medical procedures | CTCAE (Unspecified) | Systematic Assessment |
| |
| Feed tube replacement | Surgical and medical procedures | CTCAE (Unspecified) | Systematic Assessment |
| |
| PEG place | Surgical and medical procedures | CTCAE (Unspecified) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pulmonary embolism | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trisha Wise-Draper M.D., Ph.D. | University of Cincinnati Cancer Center | (513) 558-2826 | wiseth@ucmail.uc.edu |
| Feb 3, 2026 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 2 = Ambulatory, capable of self-care, unable to work |
|
| Number of adverse events |
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|