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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The goal of this trial is to test the ability of MK-3475 (pembrolizumab) to improve locoregional recurrence and distant metastatic rates in high-risk patients with locally advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current standard of care surgical approaches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 | Experimental |
|
|
| Cohort 2: Neoadjuvant MK-3475 | Experimental | -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-3475 (neoadjuvant) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional Recurrence Rates in Cohorts 1 and 2 | -The percentage of participants who developed local-regional recurrence within one year of surgery | Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose) |
| Distant Failure Rate in Cohorts 1 and 2 | -The percentage of participants who developed distant failure within one year of surgery. Distant disease is cancer that is found in another part of the body that is far away from where the original (primary) tumor first formed. | Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose) |
| Rate of Major Pathologic Treatment Effect in Cohort 1 |
| At the time of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose) |
| Rate of Major Pathologic Treatment Effect in Cohort 2 |
| At the time of surgery (surgery occurred within 13-22 days after last neoadjuvant MK-3475 dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events | Reportable adverse events will be tracked for 30 days following the last day of study treatment. For the purposes of this protocol, reportable adverse events are events thought to be possibly, probably, or definitely related to MK-3475. Events thought to be probably or definitely related to surgery, adjuvant chemotherapy, or radiotherapy need not be recorded. |
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Inclusion Criteria:
Histologically or cytologically confirmed stage III or IV HNSCC oral cavity, hypopharynx, oropharynx, larynx (excluding p16 or HPV-positive oropharynx primaries and sinonasal primaries).
Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with CT scan, as >20 mm by chest x-ray, or >10 mm with calipers by clinical exam by RECIST 1.1.
At least 18 years of age.
ECOG performance status ≤ 1
Normal bone marrow and organ function as defined below:
Sexually active women of childbearing potential and men must agree to use 2 methods of contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 120 days after last dose of MK-3475. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
Note: patients with synchronous head and neck cancer primaries are an exception to this criterion and may qualify for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Douglas R Adkins, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Washington University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32665297 | Derived | Uppaluri R, Campbell KM, Egloff AM, Zolkind P, Skidmore ZL, Nussenbaum B, Paniello RC, Rich JT, Jackson R, Pipkorn P, Michel LS, Ley J, Oppelt P, Dunn GP, Barnell EK, Spies NC, Lin T, Li T, Mulder DT, Hanna Y, Cirlan I, Pugh TJ, Mudianto T, Riley R, Zhou L, Jo VY, Stachler MD, Hanna GJ, Kass J, Haddad R, Schoenfeld JD, Gjini E, Lako A, Thorstad W, Gay HA, Daly M, Rodig SJ, Hagemann IS, Kallogjeri D, Piccirillo JF, Chernock RD, Griffith M, Griffith OL, Adkins DR. Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial. Clin Cancer Res. 2020 Oct 1;26(19):5140-5152. doi: 10.1158/1078-0432.CCR-20-1695. Epub 2020 Jul 14. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 |
|
| 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 | Apr 17, 2026 |
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| Surgery | Procedure | Standard of care |
|
| Intensity modulated radiation therapy | Radiation | Recommended, standard of care |
|
|
| Image-guided radiation therapy | Radiation | Recommended, standard of care |
|
|
| Cisplatin | Drug | Standard of care |
|
|
| MK-3475 (adjuvant) | Biological |
|
|
| Peripheral blood | Procedure | -Baseline, time of surgery (between day 14-24 inclusive), 3 months post surgery, 6 months post surgery, 9 months post surgery, 12 months post surgery |
|
| Through 30 days after last dose of MK-3475 |
| Number of Surgical Complications and/or Delays in Cohorts 1 and 2 | At the time of surgery (approximately 2-3 weeks after registration) |
| Locoregional Recurrence Rates in Cohorts 1 and 2 | Through completion of follow-up (estimated to be 5 years after treatment) |
| Rate of Distant Metastases (DM) in Cohorts 1 and 2 | Through completion of follow-up (estimated to be 5 years after treatment) |
| Event-free Survival (EFS) in Cohorts 1 and 2 | Event-free survival will be defined as time from surgery to time to disease recurrence, distant metastasis, new primary, or death due to any cause, whichever occurred first. | Through completion of follow-up (estimated to be 5 years after treatment) |
| Event-free Survival (EFS) Rate Differences by Presence Versus Absence and by Predicted Impact of Recurrent Genomic Alterations, Specifically in TP53, in Cohort 1 | Event-free survival will be defined as time from surgery to time to disease recurrence, distant metastasis, new primary, or death due to any cause, whichever occurred first. | Through completion of follow-up (estimated to be 5 years after treatment) |
| Overall Survival (OS) Rates Differences by Presence Versus Absence and by Predicted Impact of Recurrent Genomic Alterations, Specifically in TP53, in Cohort 1 | Overall survival will be defined as time from surgery to death from any cause. | Through completion of follow-up (estimated to be 5 years after treatment)] |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| FG001 | Cohort 2: Neoadjuvant MK-3475 | -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery). |
| FG002 | Not Assigned to an Arm (Cohort) | -Participants who did not receive any treatment and were not assigned to an arm (cohort). |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 |
|
| BG001 | Cohort 2: Neoadjuvant MK-3475 | -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery). |
| BG002 | Not Assigned to an Arm (Cohort) | -Participants who did not receive any treatment and were not assigned to an arm (cohort). |
| BG003 | 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 | Median | Full 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 |
|
| 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 | Locoregional Recurrence Rates in Cohorts 1 and 2 | -The percentage of participants who developed local-regional recurrence within one year of surgery | Evaluable Cohort 1 participants for this outcome measure were those who had a high-risk pathology in the surgical specimen after one dose of neoadjuvant MK-3475 (pembrolizumab). | Posted | Count of Participants | Participants | Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose) |
|
|
| |||||||||||||||||||||||||||||
| Primary | Distant Failure Rate in Cohorts 1 and 2 | -The percentage of participants who developed distant failure within one year of surgery. Distant disease is cancer that is found in another part of the body that is far away from where the original (primary) tumor first formed. | -Evaluable Cohort 1 participants for this outcome measure were those who had a high-risk pathology in the surgical specimen after one dose of neoadjuvant MK-3475 (pembrolizumab). | Posted | Count of Participants | Participants | Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose) |
| |||||||||||||||||||||||||||||||
| Primary | Rate of Major Pathologic Treatment Effect in Cohort 1 |
| Only those participants enrolled in Cohort 1 were evaluable for this outcome measure. | Posted | Count of Participants | Participants | At the time of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose) |
| |||||||||||||||||||||||||||||||
| Primary | Rate of Major Pathologic Treatment Effect in Cohort 2 |
| Only those participants enrolled in Cohort 2 were evaluable for this outcome measure. One participant in Cohort 2 not evaluable for this outcome measure because the participant did not have surgery. One participant in Cohort 2 not evaluable because the data was missing. | Posted | Count of Participants | Participants | At the time of surgery (surgery occurred within 13-22 days after last neoadjuvant MK-3475 dose) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events | Reportable adverse events will be tracked for 30 days following the last day of study treatment. For the purposes of this protocol, reportable adverse events are events thought to be possibly, probably, or definitely related to MK-3475. Events thought to be probably or definitely related to surgery, adjuvant chemotherapy, or radiotherapy need not be recorded. | Only 12 participants in Cohort 1 received adjuvant MK-3475. | Posted | Count of Participants | Participants | Through 30 days after last dose of MK-3475 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Surgical Complications and/or Delays in Cohorts 1 and 2 | One participant in Cohort 2 is not evaluable for the outcome measure because the participant did not have surgery. | Posted | Count of Participants | Participants | At the time of surgery (approximately 2-3 weeks after registration) |
| ||||||||||||||||||||||||||||||||
| Secondary | Locoregional Recurrence Rates in Cohorts 1 and 2 | Not Posted | Through completion of follow-up (estimated to be 5 years after treatment) | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Rate of Distant Metastases (DM) in Cohorts 1 and 2 | Not Posted | Through completion of follow-up (estimated to be 5 years after treatment) | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival (EFS) in Cohorts 1 and 2 | Event-free survival will be defined as time from surgery to time to disease recurrence, distant metastasis, new primary, or death due to any cause, whichever occurred first. | Not Posted | Through completion of follow-up (estimated to be 5 years after treatment) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival (EFS) Rate Differences by Presence Versus Absence and by Predicted Impact of Recurrent Genomic Alterations, Specifically in TP53, in Cohort 1 | Event-free survival will be defined as time from surgery to time to disease recurrence, distant metastasis, new primary, or death due to any cause, whichever occurred first. | Not Posted | Through completion of follow-up (estimated to be 5 years after treatment) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Rates Differences by Presence Versus Absence and by Predicted Impact of Recurrent Genomic Alterations, Specifically in TP53, in Cohort 1 | Overall survival will be defined as time from surgery to death from any cause. | Not Posted | Through completion of follow-up (estimated to be 5 years after treatment)] | Participants |
For patients who did not receive adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days following the date of surgery. For patients who received adjuvant MK-3475 (pembrolizumab), adverse events were tracked for 30 days after the last dose of MK-3475 (pembrolizumab). All-cause mortality was tracked from start of treatment through completion of follow-up (up to 5 years after surgery).
The participant not assigned to an arm due to withdrawing before receiving any treatment was not followed for all-cause mortality, serious adverse events, or adverse events.
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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 | Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 |
| 14 | 36 | 3 | 36 | 36 | 36 |
| EG001 | Cohort 2: Neoadjuvant MK-3475 | -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery). | 2 | 30 | 1 | 30 | 30 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Immune-related hepatitis | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Tracheal obstruction | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Heart murmur | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Left ear fullness | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoparathyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Conjuctivitis | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oral cavity fistula | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oral hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Swollen tongue | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Facial pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Localized edema | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Neck edema | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bone infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Pain from surgical resection | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Postoperative hemorrhage | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Tracheal obstruction | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| CPK increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac troponin I increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cholesterol high | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| INR increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Glucose intolerance | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperlipidemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagenesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness left sided | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Soft tissue necrosis: upper limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tumor flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Movements involuntary | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Psychosis | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal stones | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Laryngeal obstruction | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dermatitis radiation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Carotid artery stenosis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral ischemia | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
After enrollment of 20 patients, an interim analysis was performed to assess the feasibility to achieve the primary endpoint. The trial was amended to: a) close enrollment to cohort 1 b) addition of pTR-2 after neoadjuvant pembrolizumab in all patients as a co-primary endpoint, and c) addition of cohort 2.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas R. Adkins, M.D. | Washington University School of Medicine | 314-362-4471 | dadkins@wustl.edu |
| Apr 23, 2026 |
| Prot_SAP_002.pdf |
| 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
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D020360 | Neoadjuvant Therapy |
| D013514 | Surgical Procedures, Operative |
| D050397 | Radiotherapy, Intensity-Modulated |
| D061089 | Radiotherapy, Image-Guided |
| D002945 | Cisplatin |
| D000277 | Adjuvants, Pharmaceutic |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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 |
|
| Cohort 2: Neoadjuvant MK-3475 |
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery). |
|
|
| Cohort 2: Neoadjuvant MK-3475 |
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery). |
|
|
| OG001 | Cohort 2: Neoadjuvant MK-3475 | -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery). |
|
|
| Cohort 2: Neoadjuvant MK-3475 |
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery). |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|