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- Check4 days agoChange DetectedThe website has added information about two new interventions and updated the study's version from v2.9.7 to v2.10.0, now indicating a total of seven locations.SummaryDifference0.4%
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- Check11 days agoChange DetectedThe website has been updated to Revision v2.9.7 from v2.9.6.SummaryDifference0.1%
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- Check30 days agoChange DetectedThe value of Revision has been updated from v2.9.3 to v2.9.5, indicating a recent change in the version of the content on the webpage.SummaryDifference0.1%
- Check31 days agoChange DetectedThe value of Revision has been updated from v2.9.1 to v2.9.3, indicating a recent change in the webpage content.SummaryDifference0.1%
- Check32 days agoChange DetectedThe value 'Show more Revision: v2.9.0' has been updated to 'Drug Information available for: Ipilimumab Nivolumab FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Interventional Model Description: Arm Ia and Arm Ib are summarized in one Arm, due to central ethics committee, as they both include neoadjuvant and adjuvant treatment compared to Arm II Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Neoadjuvant/adjuvant Nivolumab and Ipilimumab Neoadjuvant dose with Nivolumab 3mg/kg after randomization within 2 weeks before surgery Surgical resection of primary tumor including neck dissection according to standard of care 6-7 weeks risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy Cisplatin 100 mg/m2 on days 1, 22, 43, or Cisplatin once weekly (40mg/m2) for high risk patients only), start within 6 weeks post-surgery Arm Ia: • Adjuvant administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months Arm Ib: • Adjuvant administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks and Ipilimumab 1mg/kg i.v. d1 every 6 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months Procedure : Surgical resection of primary tumor Surgical resection of primary tumor including neck dissection according to standard of care Radiation : Adjuvant radio(-chemo)therapy Risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy Cisplatin 100 mg/m2 on days 1, 22, 43, or Cisplatin once weekly (40mg/m2) for high risk patients only) Drug : Neoadjuvant Nivolumab Neoadjuvant dose with Nivolumab 3mg/kg after randomization within 2 weeks before surgery Drug : Adjuvant Nivolumab Administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months Drug : Adjuvant Nivolumab and Ipilimumab Administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks and Ipilimumab 1mg/kg i.v. d1 every 6 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months Active Comparator : Surgical resection + adjuvant radio(-chemo)therapy Surgical resection of primary tumor including neck dissection according to standard of care 6-7 weeks risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy Cisplatin 100 mg/m2 on days 1, 22, 43 or Cisplatin once weekly (40mg/m2) in high risk patients), start within 6 weeks post-surgery Standard follow-up Procedure : Surgical resection of primary tumor Surgical resection of primary tumor including neck dissection according to standard of care Radiation : Adjuvant radio(-chemo)therapy Risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy Cisplatin 100 mg/m2 on days 1, 22, 43, or Cisplatin once weekly (40mg/m2) for high risk patients only) Primary Outcome Measures Outcome Measure Measure Description Time Frame Disease Free Survival disease free survival (DFS) at 3 years of nivolumab alone or in combination with ipilimumab as adjuvant immunotherapy after adjuvant radio(chemo)therapy in locally advanced resected HNSCC approximately 71 months Secondary Outcome Measures Outcome Measure Measure Description Time Frame Local regional control (LRC) Disease assessment (CT/ MRI) and Panendoscopy and FFPE in case of suspicion or recurrence Time from randomization to date of first observed histologically proven or death, up to 36 month Distant metastasis free survival (DMFS) Disease assessment (CT/ MRI) Time from randomization to date of first observed histologically proven or death, up to 36 month Overall survival (OS) Follow Up- Visits after end of treatment every 3 months until month 36 after randomization, afterwards every 6 months until end of study (36 months after end of therapy of the last patient), approximately 71 months Acute toxicity and late morbidity Adverse Events Assessment AEs/SAEs should be collected continuously until 12 months after randomization Quality of life (QoL): QLQ-C30 Questionaire EORTC QLQ-C30 through study completion, an average of 3 years Quality of life (QoL): Questionnaire H&N43 Questionnaire H&N43 through study completion, an average of 3 years Comparison of nivolumab alone group vs control and nivolumab & ipilimumab group vs control in terms of DFS We compare disease free survival, defined as time from randomization to date of first observed either histologically proven recurrence (local, locoregional or distant), or death from any cause whatever occurs first, of arm Ia to arm II and of arm Ib to arm II assessed up to 36 month Survival depending on PD-L1 Status Assessment of PD-L1 Status after surgery, up to 4 weeks after surgery Additional Relevant MeSH Terms Neoplasms by Site Neoplasms Head and Neck Neoplasms Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Nivolumab IpilimumabSummaryDifference31%
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