Trial · NCT04459715
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-Free Survival (EFS) as Assessed by Blinded Independent Review Committee (BIRC) | From randomization to the earliest between any EFS event or End of Study (EOS) (up to 188 weeks and 5 days) | Event-Free Survival (EFS) as assessed by BIRC is the time from randomization to the first of: (1) Death from any cause; (2) Progression: either radiological (per RECIST v1.1) or clinical (with/without radiologic proof, assessed endoscopically); (3) Primary treatment failure prior to complete response (CR): requirement for radical salvage surgery at primary tumor site with viable tumor confirmed histologically, even without RECIST progression; (4) Relapse after CR (locoregional): including radical salvage surgery or elective neck dissection/biopsy more than equal to (\>=) 22 weeks post-randomization showing viable tumor cells regardless of radiologic status; (5) Second cancers, unless histology excludes squamous origin. Calculated via Kaplan Meier method. |
| Secondary | Overall Survival (OS) | From randomization to the earliest between death or EOS (up to 188 weeks and 5 days) | Overall survival is defined as the time from randomization to the date of death. Calculated via Kaplan Meier method. |
| Secondary | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Review Committee (BIRC) | From randomization to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause or EOS (up to 188 weeks and 5 days ) | PFS according to RECIST v1.1 defined as the time from randomization to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause. 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. Calculated via Kaplan Meier method. |
| Secondary | Locoregional Control (LRC) Time | From randomization to the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes or End Of Study (EOS) (188 weeks and 5 days) | LRC time is defined as the time from randomization to the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes, either according to RECIST v1.1 or based on clinical assessment (radiological or clinical, as assessed by the Investigator). 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. Calculated via Kaplan Meier method. |
| Secondary | Objective Response Rate (ORR) as Assessed by BIRC | At 9 and 12 months post randomization | Objective response rate was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of their diameters, and no unequivocal progression of non-target lesions. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on the study, or unequivocal progression of non-target lesions, or appearance of any new lesion. |
| Secondary | Complete Response Rate (CRR) | At 9 and 12 months post randomization | CRR defined as the number of participants with Complete Response by RECIST v1.1, as assessed by the BIRC. Complete response is defined as disappearance of all target and non-target lesions. |
| Secondary | Duration of Response (DOR) | Time from first evidence of response to the first occurrence of progression or death from any cause, assessed up to 24 months | Duration of response (DoR) defined as the time from the first evidence of response (partial or complete, as assessed by the BIRC according to RECIST v1.1) to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause. Kaplan Meier method was used for calculation. |
| Secondary | Number of Participants With Radical Salvage Surgery | At 9, 12, 24 and 36 months post randomization | Number of Participants with Radical Salvage Surgery (excluding elective neck dissection without anatomopathological evidence of residual malignant cells) was reported. |
| Secondary | Time to Subsequent Systemic Cancer Treatments | Up to 188 weeks and 5 days post randomization | Time to new subsequent systemic cancer treatment (in months) was derived as (date of event/censoring - randomization date +1) / 30.4375. Calculated via kaplan meier method. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Adverse Events (AEs) of Special Interest | From signed informed consent to EOS (up to 188 weeks and 5 days) | An AE is any unfavorable/unintended sign (e.g., abnormal lab result), symptom or disease temporally linked to study drug, whether or not related. A serious AE leads to death, is life-threatening, causes significant/persistent disability, hospitalization, congenital anomaly, or is medically important. TEAEs include both serious and non-serious AEs after treatment. AESIs are events of clinical interest needing close monitoring. In this study, AESIs include: infusion reactions including hypersensitivity, immune-related AEs, aspartate aminotransferase/alanine transaminase increases, lipase/amylase elevation, acute renal failure, QTcF more than 30 milliseconds above baseline, and ≥Grade 2 inflammatory cutaneous AEs. |
| Secondary | Number of Participants With Severity of Grade Greater or Equal to 3 TEAEs | From signed informed consent to EOS (up to 188 weeks and 5 days) | Severity of TEAEs were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version. The grade are as follows: grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE. |
| Secondary | Change From Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change) | Change from Baseline in Laboratory Parameters: Basophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets was reported. |
| Secondary | Percent Change From Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | At Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change) | Change from Baseline in Laboratory Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes was reported. |
| Secondary | Change From Baseline in Laboratory Parameters: Erythrocytes | At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change) | Change from Baseline in Laboratory Parameters: Erythrocytes was reported. |
| Secondary | Change From Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein | At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change) | Change from Baseline in Laboratory Parameters: Hemoglobin, Albumin, Protein was reported. |
| Secondary | Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase | At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change) | Change from Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Lipase was reported. |
| Secondary | Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate | At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change) | Change from Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Urate was reported. |
| Secondary | Change From Baseline in Laboratory Parameters: C Reactive Protein | At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change) | Change from Baseline in Laboratory Parameters: C Reactive Protein was reported. |
| Secondary | Change From Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea | At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change) | Change from Baseline in Laboratory Parameters: Calcium, Magnesium, Potassium, Sodium, Urea was reported. |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate | At Baseline, Cycle 3 Day 1 (C3D1) (combination period), EOT (15 days after last study treatment administration) and baseline upto event free survival (EFS) follow up Month 18 after EOT (max on treatment change) | Change from baseline in biochemistry parameter eGFR was reported. The Glomerular Filtration Rate was measured as milliliter per minute per 1.73 square meter (mL/min/1.73m\^2). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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