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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-B10 | Other Identifier | MSD |
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The goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with carboplatin and paclitaxel as first-line treatment in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab + Carboplatin + Paclitaxel | Experimental | Participants will receive pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab will be administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Carboplatin will be administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). At investigator's choice, paclitaxel will be administered via IV infusion at a dose of 100 mg/m^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to ~4 months) or at a dose of 175 mg/m^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab 200 mg IV infusion given on Day 1 of each 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per Response Evaluation Criteria in Solid Tumors Update and Clarification 1.1 (RECIST 1.1) which was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR as assessed by blinded independent central review based on RECIST 1.1 was presented. | Up to ~25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. RECIST 1.1 was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR as assessed by blinded independent central review based on RECIST 1.1 was presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital-Yale Cancer Center ( Site 0265) | New Haven | Connecticut | 06510 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39038265 | Result | Dzienis M, Cundom J, Fuentes CS, Spreafico A, Nordlinger M, Pastor AV, Alesi E, Neki A, Fung AS, Figueiredo Lima IP, Oppelt P, da Cunha Junior GF, Burtness B, Franke FA, Tseng JE, Joshi A, McCarthy J, Swaby R, Sidi Y, Gumuscu B, Naicker N, de Castro G Jr. Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial. J Clin Oncol. 2024 Sep 1;42(25):2989-2999. doi: 10.1200/JCO.23.02625. Epub 2024 Jul 22. |
| Label | URL |
|---|---|
| Merck Oncology Clinical Trials Information | View source |
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101 participants were enrolled in the All Participants as Treated (APaT) population. The APaT population consisted of all allocated participants who received at least one dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab + Carboplatin + Paclitaxel | Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to ~4 months) or at a dose of 175 mg/m^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). |
| 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 | Aug 16, 2022 |
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| Carboplatin | Drug | Carboplatin AUC 5 mg/mL/minute IV infusion given on Day 1 of each 21-day cycle |
|
|
| Paclitaxel | Drug | At investigator's choice, paclitaxel 100 mg/m^2 IV infusion given on Day 1 and Day 8 of each 21-day cycle or paclitaxel 175 mg/m^2 IV infusion given on Day 1 of each 21-day cycle |
|
|
| Up to ~25 months |
| Progression-free Survival (PFS) | PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was been adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS as assessed by blinded independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data. | Up to ~25 months |
| Overall Survival (OS) | OS was defined as the time from first dose of study treatment to death due to any cause. PFS as assessed by blinded independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data. | Up to ~25 months |
| Percentage of Participants Who Experienced an Adverse Event (AE) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE was reported. | Up to ~39 months |
| Percentage of Participants Who Discontinued Study Treatment Due to an AE | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study treatment due to an AE was reported. | Up to ~25 months |
| Helen F. Graham Cancer Center & Research Institute ( Site 0214) |
| Newark |
| Delaware |
| 19718 |
| United States |
| Baptist MD Anderson Cancer Center ( Site 0215) | Jacksonville | Florida | 32207 | United States |
| Orlando Health, Inc. ( Site 0216) | Orlando | Florida | 32806 | United States |
| Regions Hospital ( Site 0227) | Saint Paul | Minnesota | 55101 | United States |
| Washington University School of Medicine ( Site 0240) | St Louis | Missouri | 63110 | United States |
| Erie County Medical Center-Head & Neck Surgery and Plastic & Reconstructive Surgery ( Site 0268) | Buffalo | New York | 14215 | United States |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0262) | Mineola | New York | 11501 | United States |
| Novant Health Presbyterian ( Site 0261) | Charlotte | North Carolina | 28204 | United States |
| Novant Health Forsyth Medical Center ( Site 0266) | Winston-Salem | North Carolina | 27103 | United States |
| UPMC Hillman Cancer Center ( Site 0253) | Pittsburgh | Pennsylvania | 15232 | United States |
| Abington Hospital - Asplundh Cancer Center ( Site 0229) | Willow Grove | Pennsylvania | 19090 | United States |
| Charleston Oncology ( Site 0231) | Charleston | South Carolina | 29414 | United States |
| Virginia Commonwealth University ( Site 0233) | Richmond | Virginia | 23219 | United States |
| Hospital Provincial del Centenario ( Site 0304) | Rosario | Santa Fe Province | 2000 | Argentina |
| Centro Medico San Roque ( Site 0302) | San Miguel de Tucumán | Tucumán Province | T4000IAK | Argentina |
| IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0303) | Buenos Aires | C1012AAR | Argentina |
| Fundación Respirar ( Site 0306) | Buenos Aires | C1426ABP | Argentina |
| Instituto Medico Especializado Alexander Fleming ( Site 0301) | Buenos Aires | C1426ANZ | Argentina |
| Orange Health Services ( Site 0106) | Orange | New South Wales | 2800 | Australia |
| The Townsville Hospital ( Site 0105) | Douglas | Queensland | 4814 | Australia |
| Gold Coast University Hospital ( Site 0103) | Southport | Queensland | 4215 | Australia |
| St Vincents Hospital Melbourne ( Site 0101) | Fitzroy | Victoria | 3065 | Australia |
| Centro Regional Integrado de Oncologia ( Site 0403) | Fortaleza | Ceará | 60336-232 | Brazil |
| CETUS Hospital Dia Oncologia ( Site 0400) | Belo Horizonte | Minas Gerais | 30110-022 | Brazil |
| Liga Norte Riograndense Contra o Cancer ( Site 0404) | Natal | Rio Grande do Norte | 59075-740 | Brazil |
| ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0406) | Ijuà | Rio Grande do Sul | 98700-000 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0402) | São Paulo | 01246-000 | Brazil |
| Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0401) | São Paulo | 01321-001 | Brazil |
| A.C. Camargo Cancer Center ( Site 0405) | São Paulo | 01509-900 | Brazil |
| Tom Baker Cancer Center ( Site 0014) | Calgary | Alberta | T2N 4N2 | Canada |
| Dr. H. Bliss Murphy Cancer Centre ( Site 0001) | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital ( Site 0004) | Kingston | Ontario | K7L 2V7 | Canada |
| Princess Margaret Cancer Centre ( Site 0005) | Toronto | Ontario | M5G 2M9 | Canada |
| CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0003) | Sherbrooke | Quebec | J1H 5N4 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab + Carboplatin + Paclitaxel | Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to ~4 months) or at a dose of 175 mg/m^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 (ORR) | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per Response Evaluation Criteria in Solid Tumors Update and Clarification 1.1 (RECIST 1.1) which was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR as assessed by blinded independent central review based on RECIST 1.1 was presented. | APaT population, which included all participants enrolled who received at least 1 dose of study intervention | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to ~25 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. RECIST 1.1 was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR as assessed by blinded independent central review based on RECIST 1.1 was presented. | Participants in APaT population who had either a CR or PR | Posted | Median | 95% Confidence Interval | Months | Up to ~25 months |
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was been adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS as assessed by blinded independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data. | APaT population, which included all participants enrolled who received at least 1 dose of study intervention | Posted | Median | 95% Confidence Interval | Months | Up to ~25 months |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from first dose of study treatment to death due to any cause. PFS as assessed by blinded independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data. | APaT population, which included all participants enrolled who received at least 1 dose of study intervention | Posted | Median | 95% Confidence Interval | Months | Up to ~25 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced an Adverse Event (AE) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE was reported. | APaT population, which included all participants enrolled who received at least 1 dose of study intervention | Posted | Number | Percentage of participants | Up to ~39 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Discontinued Study Treatment Due to an AE | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study treatment due to an AE was reported. | APaT population, which included all participants enrolled who received at least 1 dose of study intervention. | Posted | Number | Percentage of Participants | Up to ~25 months |
|
|
Up to approximately 39 months
Serious and Other adverse events (AEs) include all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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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 | Pembrolizumab + Carboplatin + Paclitaxel | Participants received pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab was administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Carboplatin was administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). At investigator's choice, paclitaxel was administered via IV infusion at a dose of 100 mg/m^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to ~4 months) or at a dose of 175 mg/m^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). | 75 | 101 | 52 | 101 | 100 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tongue necrosis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infected fistula | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Myelitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Stoma site infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
If publication activity was not directed by the Sponsor, the investigator agreed to submit all manuscripts or abstracts to the Sponsor before submission. This allowed the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Jun 9, 2025 |
| Prot_SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| 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 |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|