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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505796-76-00 | Other Identifier | EU CTIS |
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No major safety concerns were identified in HyperlynX study, but Lack of evidence of efficacy of meaningful clinical benefit.
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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The purpose of this study is to evaluate the tolerability and safety of Xevinapant when added to weekly cisplatin-based concurrent chemoradiotherapy (CRT) in the treatment of participants with unresectable locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xevinapant + Cisplatin + IMRT | Experimental | Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xevinapant | Drug | Participants will receive xevinapant once daily from Day 1 to Day 14, per 3-week cycle (Each cycle is of 3 weeks). The first three cycles are given in combination with weekly cisplatin and radiotherapy, followed by 3 cycles of monotherapy xevinapant. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicity (DLT)-Like Events | DLT-like events defined as any of the following treatment-related adverse events (AEs) or lab abnormalities occurring during the 5-week DLT-like assessment period and assessed as related to the study intervention: Grade 4 asymptomatic neutropenia more than (>) 7 days; Grade 2-3 febrile neutropenia; Grade 4 thrombocytopenia without bleeding more than and equal to (>=) 5 days or Grade 2-3 with bleeding or requiring transfusion; Grade 2-3 nonhematologic toxicity (e.g., renal impairment based on eGFR, Grade 4 skin toxicity/mucositis interfering with treatment); less than (<) 60% planned cumulative dose of xevinapant or cisplatin due to AE; >2-week Radiation therapy (RT) delay due to AE; Grade >=2 ototoxicity worsening >=2 grades from baseline and considered treatment-limiting; Hy's Law DILI; Grade >=3 lab abnormalities; any life-threatening or Grade 5 toxicity. | Time from the first dose of study intervention day upto 35 days (5 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs | AEs were defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs were defined as AEs emerging or worsening after start of treatment until 30 days after end of treatment. Adverse events were coded according to the latest available version of the Medical Dictionary for Regulatory Activities (MedDRA). Treatment-Related TEAEs was defined as any AE considered as related to study treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Research & Development Institute, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States | ||
| Karmanos Cancer Institute - PARENT |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 27, 2023 | Jul 30, 2025 |
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|
| Cisplatin | Drug | Participants will receive weekly cisplatin for 7 weeks on Cycle 1 Day 2 (C1D2), C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2). |
|
| intensity-modulated radiation therapy (IMRT) | Radiation | Participants will receive 70 Gray (Gy) of IMRT in 35 fractions, 2 Gy/fraction, 5 days/week |
|
| Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months) |
| Absolute Estimated Glomerular Filtration Rate (eGFR) Values | eGFR creatinine was evaluated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Absolute values in eGFR was presented. Here, mL/min/1.73 m^2 is defined as milliliters per minute per 1.73 square meters. | At Cycle1 Day 4 (C1D4), C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks) |
| Absolute Change From Baseline in eGFR | eGFR creatinine was evaluated using CKD-EPI formula. Absolute change from baseline in eGFR was presented. | Baseline, C1D4, C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks) |
| Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 Criteria as Assessed by Investigator | OR is defined as the number of participants who have a best overall response of complete response (CR) or partial response (PR) CR: Disappearance of target and non-target lesions and normalization of tumor markers. PR: At least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non target lesions must be non-progressive disease. | Up to approximately 6 months |
| Progression Free Survival (PFS) According to RECIST Version 1.1 Criteria as Assessed by Investigator | PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on Blinded Independent Central Review (BICR), or death due to any cause, whichever occurs first. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 millimeter (mm) in the SOD, or the appearance of new lesions. | Time from randomization to the first documented disease progression, or death due to any cause, whichever occurs first (up to approximately 6 months) |
| Locoregional Control (LRC) According to RECIST Version 1.1 Criteria As Assessed by Investigator | LRC is defined as the time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes. | Time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes or End of Study, assessed approximately up to 6 months |
| Time to Subsequent Systemic Cancer Treatments | Time to subsequent systematic cancer treatments was defined as time from date of the first treatment administration until the start date of the first subsequent systemic cancer treatment for squamous cell carcinoma of the head and neck (SCCHN). | Time from date of the first treatment administration until the start date of the first subsequent systemic cancer treatment for SCCHN or End of study, assessed up to approximately 6 months |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Montefiore Medical Center PRIME | The Bronx | New York | 10467 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Avera McKennan Hospital and University Health Center | Sioux Falls | South Dakota | 57105 | United States |
| Uza - Parent | Edegem | Belgium |
| Universitair Ziekenhuis Gent - Medical Oncology | Ghent | Belgium |
| Centre Hospitalier de l'Ardenne - PARENT | Libramont | Belgium |
| Vitaz | Sint-Niklaas | Belgium |
| Hadassah University Hospital - Ein Kerem | Jerusalem | Israel |
| Pusan National University Hospital | Busan | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Konkuk University Medical Center | Seoul | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | South Korea |
| ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica | Girona | Spain |
| Clinica Universidad de Navarra (MAD) - Oncology Service | Madrid | Spain |
| Hospital Universitario Fundacion Jimenez Diaz - Oncology | Madrid | Spain |
| Hospital Universitario Virgen del Rocio - Oncology Service | Seville | Spain |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks). |
| 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 |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Number of Participants With Dose Limiting Toxicity (DLT)-Like Events | DLT-like events defined as any of the following treatment-related adverse events (AEs) or lab abnormalities occurring during the 5-week DLT-like assessment period and assessed as related to the study intervention: Grade 4 asymptomatic neutropenia more than (>) 7 days; Grade 2-3 febrile neutropenia; Grade 4 thrombocytopenia without bleeding more than and equal to (>=) 5 days or Grade 2-3 with bleeding or requiring transfusion; Grade 2-3 nonhematologic toxicity (e.g., renal impairment based on eGFR, Grade 4 skin toxicity/mucositis interfering with treatment); less than (<) 60% planned cumulative dose of xevinapant or cisplatin due to AE; >2-week Radiation therapy (RT) delay due to AE; Grade >=2 ototoxicity worsening >=2 grades from baseline and considered treatment-limiting; Hy's Law DILI; Grade >=3 lab abnormalities; any life-threatening or Grade 5 toxicity. | DLT analysis set: all participants who received any study dose, met at least 1 of criteria: Had at least one DLT like event confirmed by SMC during DLT like assessment period or for whom ICE strategy led to DLT event, regardless of administered number of doses; Received at least 60% planned cumulative dose of xevinapant, cisplatin, regardless of completion in assessment period. | Posted | Count of Participants | Participants | Time from the first dose of study intervention day upto 35 days (5 weeks) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs | AEs were defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs were defined as AEs emerging or worsening after start of treatment until 30 days after end of treatment. Adverse events were coded according to the latest available version of the Medical Dictionary for Regulatory Activities (MedDRA). Treatment-Related TEAEs was defined as any AE considered as related to study treatment. | Safety analysis set (SAS) included all participants who were administered any dose of any study intervention. | Posted | Count of Participants | Participants | Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months) |
| ||||||||||||||||||||||||||||
| Secondary | Absolute Estimated Glomerular Filtration Rate (eGFR) Values | eGFR creatinine was evaluated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Absolute values in eGFR was presented. Here, mL/min/1.73 m^2 is defined as milliliters per minute per 1.73 square meters. | SAS included all participants who were administered any dose of any study intervention. Here" overall number of participants analyzed signified" participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints. | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | At Cycle1 Day 4 (C1D4), C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks) |
|
| ||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in eGFR | eGFR creatinine was evaluated using CKD-EPI formula. Absolute change from baseline in eGFR was presented. | SAS included all participants who were administered any dose of any study intervention. Here "number analyzed" signifies participants who were evaluable at specified timepoints. | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | Baseline, C1D4, C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks) |
|
| ||||||||||||||||||||||||||
| Secondary | Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 Criteria as Assessed by Investigator | OR is defined as the number of participants who have a best overall response of complete response (CR) or partial response (PR) CR: Disappearance of target and non-target lesions and normalization of tumor markers. PR: At least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non target lesions must be non-progressive disease. | FAS included all participants who were administered any dose of any study intervention. As pre-specified in statistical analysis plan (SAP), efficacy analysis was not conducted in this study (samples were not processed) and therefore data could not be analyzed and reported in this outcome measure. | Posted | Up to approximately 6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) According to RECIST Version 1.1 Criteria as Assessed by Investigator | PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on Blinded Independent Central Review (BICR), or death due to any cause, whichever occurs first. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 millimeter (mm) in the SOD, or the appearance of new lesions. | Full Analysis Set included all participants who were randomized to study treatment. As pre-specified in SAP, efficacy analysis was not conducted in this study (samples were not processed) and therefore data could not be analyzed and reported in this outcome measure. | Posted | Time from randomization to the first documented disease progression, or death due to any cause, whichever occurs first (up to approximately 6 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Locoregional Control (LRC) According to RECIST Version 1.1 Criteria As Assessed by Investigator | LRC is defined as the time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes. | Full Analysis Set included all participants who were randomized to study treatment. As pre-specified in SAP, efficacy analysis was not conducted in this study (samples were not processed) and therefore data could not be analyzed and reported in this outcome measure. | Posted | Time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes or End of Study, assessed approximately up to 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Subsequent Systemic Cancer Treatments | Time to subsequent systematic cancer treatments was defined as time from date of the first treatment administration until the start date of the first subsequent systemic cancer treatment for squamous cell carcinoma of the head and neck (SCCHN). | Full Analysis Set included all participants who were randomized to study treatment. As pre-specified in SAP, efficacy analysis was not conducted in this study (samples were not processed) and therefore data could not be analyzed and reported in this outcome measure. | Posted | Time from date of the first treatment administration until the start date of the first subsequent systemic cancer treatment for SCCHN or End of study, assessed up to approximately 6 months |
|
|
Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
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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 | Sequence 1 | Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks). | 0 | 18 | 5 | 18 | 18 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure chronic | Cardiac disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Central serous chorioretinopathy | Eye disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Tongue fungal infection | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Hypogeusia | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 14, 2025 | Jul 30, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C559144 | N-benzhydryl-5-(2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo(1,2-a)(1,5)diazocine-8-carboxamide |
| D002945 | Cisplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Race-Asian |
|
| Race-Black or African American |
|
| Race-White |
|
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| Participants |
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| Participants |
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| Units | Counts |
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| Participants |
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| Participants |
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