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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 60320 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is a single-arm, non-randomized pilot study to evaluate the efficacy and tolerability of combination quad-shot palliative radiotherapy with immunotherapy for advanced/recurrent/metastatic head and neck cancer.
Primary Objective: Measure the overall response rate for immunotherapy given with quad-shot radiotherapy.
Secondary Objective(s)
Exploratory Objective: Evaluate the effect of quad- shot administration on increasing the immune activation by treatment with pembrolizumab and investigate possible mechanisms.
OUTLINE: Patients receive standard of care pembrolizumab intravenously (IV) over 30 minutes every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo quad-shot radiation therapy twice daily (BID) on 2 consecutive days between cycles 2-3 or 3-4, 6-7, and 11-12 of pembrolizumab treatment and in the last week of pembrolizumab treatment.
After completion of study treatment, patients are followed up at 1 and 2 months for adverse events monitoring. Patients will be followed until death for monitoring survival study endpoints. Frequency of visits will be established by the treating physician and will be done in person or over the phone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quad-shot palliative radiotherapy and Immunotherapy | Experimental | Systemic therapy (ICI) and radiotherapy will be administered according to the standard of care, according to the treating medical oncologist and radiation oncologist, respectively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab (immunotherapy) | Drug | Pembrolizumab 200 mg will be given every 3 weeks to tumor progression or treatment tolerance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response - | Overall response will be measured according to RECIST 1.1 criteria to determine the percentage of participants with either a partial or complete response and the corresponding 95% Clopper-Pearson exact confidence interval. The best overall response is the best response recorded from the start of the treatment across all time points. COMPLETE RESPONSE: Disappearance (or decrease to the point at which measurement is not possible) of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (the sum may not be "0" if there are target nodes) PARTIAL RESPONSE: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate in the Target Lesions | Response rate will be measured as the following: Complete: Disappearance (or decrease to the point at which measurement is not possible) of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial: At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease: Greater than 20% increase in the sum of the longest diameters (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir. When sum becomes very small, increases within measurement error (2-3 mm) can lead to 20% increase. Stable Disease: Greater than 20% increase in the sum of the longest diameters (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir. When sum becomes very small, increases within measurement error (2-3 mm) can lead to 20% increase. |
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Inclusion Criteria:
MALES: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) (divided by) 72 x serum creatinine (mg/dL).
FEMALES: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 (divided by) 72 x serum creatinine (mg/dL)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mercedes Porosnicu, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42313403 | Derived | Hughes RT, Smith S, Lycan TW Jr, Bunch PM, D'Agostino RB Jr, Frizzell BA, Kinney RD, Rashid S, Triozzi P, Zhang W, Furdui CM, Porosnicu M. Pembrolizumab Plus Quad-Shot Radiotherapy for Recurrent, Unresectable, or Metastatic Head and Neck Cancer: A Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Jun 18:e261527. doi: 10.1001/jamaoto.2026.1527. Online ahead of print. | |
| 37199326 | Derived | Hughes RT, Gebeyehu RR, Kalada JM, Lycan TW, Frizzell BA, Kinney RD, D'Agostino RB, Bunch PM, Triozzi P, Zhang W, Furdui CM, Porosnicu M. Quad-shot-immunotherapy: quad-shot radiotherapy with pembrolizumab for advanced/recurrent head and neck cancer. Future Oncol. 2023 Jul;19(22):1523-1534. doi: 10.2217/fon-2022-1146. Epub 2023 May 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Quad-shot Palliative Radiotherapy and Immunotherapy | Systemic therapy (ICI) and radiotherapy will be administered according to the standard of care, according to the treating medical oncologist and radiation oncologist, respectively Pembrolizumab (immunotherapy): Pembrolizumab 200 mg will be given every 3 weeks to tumor progression or treatment tolerance. Quad-shot palliative radiotherapy: - Each cycle of quad-shot radiotherapy will be comprised of 14.8 Gy in 4 fractions (3.7 Gy per fraction) delivered twice daily (at least 6 hours apart) over two consecutive days.
Therefore, the total prescription dose will be:
|
| 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 | Jun 26, 2023 |
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| Quad-shot palliative radiotherapy | Radiation |
Therefore, the total prescription dose will be:
|
|
| Up to 2 years |
| Response Rate in the Non-Target Lesions | Response rate will be measured using RECIST 1.1: Complete: Disappearance (or decrease to the point at which measurement is not possible) of all non-target lesions. All lymph nodes must be non-pathological in size (< 10 mm short axis). Partial: Non-complete response/Non-progressive disease: Persistence of 1 or more non-target lesion(s). Progressive Disease: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Stable Disease: Greater than 20% increase in the sum of the longest diameters (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir. When sum becomes very small, increases within measurement error (2-3 mm) can lead to 20% increase. | Up to 2 years |
| Duration of Response at the Target Lesions - Mean Measurement | For the duration of response, among participants investigators will estimate both the mean duration and the corresponding 95% confidence intervals for the mean and inter-quartile range for the median. The duration of response at the target lesion will be defined as the duration from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date of recurrent or progressive disease. | Up to 2 years |
| Duration of Response at the Target Lesions - Median Measurement | The duration of response at the target lesion(s) will be defined as the duration from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date of recurrent or progressive disease. For the duration of response, among participants investigators will estimate the median duration and the corresponding 95% confidence intervals for the mean and inter-quartile range for the median. Target Lesions: COMPLETE RESPONSE: Disappearance (or decrease to the point at which measurement is not possible) of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (the sum may not be "0" if there are target nodes) PARTIAL RESPONSE: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters | Up to 2 years |
| Progression-Free Survival | For progression-free survival investigators will estimate Kaplan Meier survival curves and the median time to progression-free survival, as well as survival rates at 6 months and 1 year post treatment. Progression-Free Survival is defined as the duration of time from registration to the time of progression, death, or date of last contact; those lost to follow-up will be censored. | Up to 2 years. |
| Progression-Free Survival - Survival Rate Percentages | For progression-free survival investigators will estimate Kaplan Meier survival curves and the median time to progression-free survival, as well as survival rates at 6 months and 1 year post treatment. Progression-Free Survival is defined as the duration of time from registration to the time of progression, death, or date of last contact; those lost to follow-up will be censored. | Up to 2 years. |
| Overall Survival - Months | For time to event measure of overall survival investigators will estimate Kaplan Meier survival curves and the median time to overall survival, as well as survival rates at 6 months and 1 year post treatment. Overall Survival is defined as the duration of time from registration to date of death or date of last contact; those lost to follow-up will be censored. | Up to 2 years |
| Overall Survival - Survival Rate Percentages | For time to event measure of overall survival investigators will estimate Kaplan Meier survival curves and the median time to overall survival, as well as survival rates at 6 months and 1 year post treatment. Overall Survival is defined as the duration of time from registration to date of death or date of last contact; those lost to follow-up will be censored. | Up to 2 years |
| Tolerability - Adverse Events Assessed Using PRO-CTCAE Version 5.0 | Tolerability of intervention will be assessed using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Event (PRO CTCAE). Investigators will estimate the percentage of patients with different adverse events using a 95% Clopper Pearson exact confidence level. Listed adverse events were grade 3+ and deemed at least possibly related to therapy. | Up to 2 years |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All patients enrolled in the study with informed consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Quad-shot Palliative Radiotherapy and Immunotherapy | Systemic therapy (ICI) and radiotherapy will be administered according to the standard of care, according to the treating medical oncologist and radiation oncologist, respectively Pembrolizumab (immunotherapy): Pembrolizumab 200 mg will be given every 3 weeks to tumor progression or treatment tolerance. Quad-shot palliative radiotherapy: - Each cycle of quad-shot radiotherapy will be comprised of 14.8 Gy in 4 fractions (3.7 Gy per fraction) delivered twice daily (at least 6 hours apart) over two consecutive days.
Therefore, the total prescription dose will be:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Primary Cancer Site | 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 | Overall Response - | Overall response will be measured according to RECIST 1.1 criteria to determine the percentage of participants with either a partial or complete response and the corresponding 95% Clopper-Pearson exact confidence interval. The best overall response is the best response recorded from the start of the treatment across all time points. COMPLETE RESPONSE: Disappearance (or decrease to the point at which measurement is not possible) of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (the sum may not be "0" if there are target nodes) PARTIAL RESPONSE: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters | Five of the patients who started treatment were not evaluable for response. The number entered below is the percentage with a complete or partial response. A 95% Clopper Pearson exact confidence interval on the rate is reported. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 years |
|
|
| |||||||||||||||||||||||||
| Secondary | Response Rate in the Target Lesions | Response rate will be measured as the following: Complete: Disappearance (or decrease to the point at which measurement is not possible) of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial: At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease: Greater than 20% increase in the sum of the longest diameters (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir. When sum becomes very small, increases within measurement error (2-3 mm) can lead to 20% increase. Stable Disease: Greater than 20% increase in the sum of the longest diameters (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir. When sum becomes very small, increases within measurement error (2-3 mm) can lead to 20% increase. | Five of the patients who started treatment were not evaluable for response. The number entered below is the percentage with a complete or partial response. A 95% Clopper Pearson exact confidence interval on the rate is reported. | Posted | Number | 95% Confidence Interval | percentage of evaluable patients | Up to 2 years |
| |||||||||||||||||||||||||||
| Secondary | Response Rate in the Non-Target Lesions | Response rate will be measured using RECIST 1.1: Complete: Disappearance (or decrease to the point at which measurement is not possible) of all non-target lesions. All lymph nodes must be non-pathological in size (< 10 mm short axis). Partial: Non-complete response/Non-progressive disease: Persistence of 1 or more non-target lesion(s). Progressive Disease: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Stable Disease: Greater than 20% increase in the sum of the longest diameters (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir. When sum becomes very small, increases within measurement error (2-3 mm) can lead to 20% increase. | Five of the patients who started treatment were not evaluable for response. The number entered below is the percentage with a complete or partial response. A 95% Clopper Pearson exact confidence interval on the rate is reported. | Posted | Number | 95% Confidence Interval | percentage of evaluable patients | Up to 2 years |
| |||||||||||||||||||||||||||
| Secondary | Duration of Response at the Target Lesions - Mean Measurement | For the duration of response, among participants investigators will estimate both the mean duration and the corresponding 95% confidence intervals for the mean and inter-quartile range for the median. The duration of response at the target lesion will be defined as the duration from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date of recurrent or progressive disease. | Six patients had either a complete or partial response. | Posted | Mean | 95% Confidence Interval | months | Up to 2 years |
| |||||||||||||||||||||||||||
| Secondary | Duration of Response at the Target Lesions - Median Measurement | The duration of response at the target lesion(s) will be defined as the duration from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date of recurrent or progressive disease. For the duration of response, among participants investigators will estimate the median duration and the corresponding 95% confidence intervals for the mean and inter-quartile range for the median. Target Lesions: COMPLETE RESPONSE: Disappearance (or decrease to the point at which measurement is not possible) of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (the sum may not be "0" if there are target nodes) PARTIAL RESPONSE: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters | Six evaluable patients had a complete or partial response. | Posted | Median | Inter-Quartile Range | months | Up to 2 years |
| |||||||||||||||||||||||||||
| Secondary | Progression-Free Survival | For progression-free survival investigators will estimate Kaplan Meier survival curves and the median time to progression-free survival, as well as survival rates at 6 months and 1 year post treatment. Progression-Free Survival is defined as the duration of time from registration to the time of progression, death, or date of last contact; those lost to follow-up will be censored. | 20 patients received at least one cycle of therapy. | Posted | Median | 95% Confidence Interval | months | Up to 2 years. |
| |||||||||||||||||||||||||||
| Secondary | Progression-Free Survival - Survival Rate Percentages | For progression-free survival investigators will estimate Kaplan Meier survival curves and the median time to progression-free survival, as well as survival rates at 6 months and 1 year post treatment. Progression-Free Survival is defined as the duration of time from registration to the time of progression, death, or date of last contact; those lost to follow-up will be censored. | 20 patients received at least one cycle of therapy. | Posted | Count of Participants | Participants | Up to 2 years. |
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival - Months | For time to event measure of overall survival investigators will estimate Kaplan Meier survival curves and the median time to overall survival, as well as survival rates at 6 months and 1 year post treatment. Overall Survival is defined as the duration of time from registration to date of death or date of last contact; those lost to follow-up will be censored. | 20 patients received at least one cycle of therapy. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival - Survival Rate Percentages | For time to event measure of overall survival investigators will estimate Kaplan Meier survival curves and the median time to overall survival, as well as survival rates at 6 months and 1 year post treatment. Overall Survival is defined as the duration of time from registration to date of death or date of last contact; those lost to follow-up will be censored. | 20 patients received at least one cycle of therapy.The 6-month survival rate was 69.6%; the 12-month survival rate was 51.4% | Posted | Count of Participants | Participants | Up to 2 years |
| ||||||||||||||||||||||||||||
| Secondary | Tolerability - Adverse Events Assessed Using PRO-CTCAE Version 5.0 | Tolerability of intervention will be assessed using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Event (PRO CTCAE). Investigators will estimate the percentage of patients with different adverse events using a 95% Clopper Pearson exact confidence level. Listed adverse events were grade 3+ and deemed at least possibly related to therapy. | For evaluable patients, the percentage of patients with the listed adverse event is given below with a 95% exact confidence interval. | Posted | Number | 95% Confidence Interval | percentage of evaluable patients | Up to 2 years |
|
Adverse events were recorded with each treatment cycle, up to 2 years.
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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 | Quad-shot Palliative Radiotherapy and Immunotherapy | Systemic therapy (ICI) and radiotherapy will be administered according to the standard of care, according to the treating medical oncologist and radiation oncologist, respectively Pembrolizumab (immunotherapy): Pembrolizumab 200 mg will be given every 3 weeks to tumor progression or treatment tolerance. Quad-shot palliative radiotherapy: - Each cycle of quad-shot radiotherapy will be comprised of 14.8 Gy in 4 fractions (3.7 Gy per fraction) delivered twice daily (at least 6 hours apart) over two consecutive days.
Therefore, the total prescription dose will be:
| 13 | 20 | 15 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Floaters | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Colonic perforation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Oral hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Death | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Disease progression | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Infections and Infestations | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Tracheostomy site bleeding | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Weight Loss | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Tumor Hemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
| |
| Facial muscle weakness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vasovagal Reaction | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Respiratory Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Bullous (Dermatitis) Pemphigoid | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Thromboembolic Event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Low Hemoglobin | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hearing impairment | Ear and labyrinth disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| GERD | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Swallowing difficulties | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Edema of limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| ALT increase | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| AST increase | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Alkaline Phosphatase increase | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Creatinine increase | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Lipase increase | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Lymphocyte count decrease | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Serum amylase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| TSH increase | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| WBC decrease | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Parethesia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Headaches | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chronis Kidney disease | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Productive Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Macupapular rash | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Hot flashes | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
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| Lymphedema | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
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Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Wake Forest Baptist Comprehensive Cancer Center | 336 -713-5440 | mporosnicu@wakehealth.edu |
| Jun 18, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 13, 2024 | Jun 18, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Hispanic |
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| Oral Cavity |
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| R Temporal Fossa |
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