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- Check4 days agoChange DetectedThe study has been updated to version v2.10.0, replacing the previous version v2.9.7.SummaryDifference0.4%
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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Prostate cancer MedlinePlus related topics: Prostate Cancer Drug Information available for: Ipilimumab Nivolumab FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Non-Randomized Interventional Model : Single Group Assignment Interventional Model Description: Two-arm non-randomised, non-comparative phase II trial Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Nivolumab & Ipilimumab - Cohort 1 Patients will receive Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every three weeks for a maximum of 4 doses followed by a 6 week gap after last combination dose. The patients will then receive 480 mg flat dose of nivolumab every 4 weeks for up to one year, or until progression, unacceptable toxicity or withdrawal of consent. Drug : Nivolumab & Ipilimumab Combination Therapy: Cohort 1: Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks for a maximum of 4 cycles. Cohort 2 : Nivolumab 3mg/kg + ipilimumab 1mg/kg every 3 weeks for a maximum of 4 cycles. Treatment free gap after last combination dose : Cohort 1: 6 weeks; Cohort 2: 3 weeks Monotherapy: 480 mg flat dose of nivolumab every 4 weeks for up to 10 cycles, or until progression, unacceptable toxicity or withdrawal of consent Experimental : Nivolumab & Ipilimumab - Cohort 2 Patients will receive Nivolumab 3 mg/kg + ipilimumab 1 mg/kg every three weeks for a maximum of 4 doses followed by a 3 week gap after last combination dose. The patients will then receive 480 mg flat dose of nivolumab every 4 weeks for up to one year, or until progression, unacceptable toxicity or withdrawal of consent. Drug : Nivolumab & Ipilimumab Combination Therapy: Cohort 1: Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks for a maximum of 4 cycles. Cohort 2 : Nivolumab 3mg/kg + ipilimumab 1mg/kg every 3 weeks for a maximum of 4 cycles. Treatment free gap after last combination dose : Cohort 1: 6 weeks; Cohort 2: 3 weeks Monotherapy: 480 mg flat dose of nivolumab every 4 weeks for up to 10 cycles, or until progression, unacceptable toxicity or withdrawal of consent Primary Outcome Measures Outcome Measure Measure Description Time Frame Composite response rate Patients will be considered as having had a treatment response if any one of the following criteria are satisfied: Radiological response (RECIST 1.1) PSA response ≥50% confirmed by a second PSA test at least 4 weeks later (PCWG3 2016) Conversion of CTC count from ≥5 cells/7.5ml at baseline to <5 cells/7.5ml confirmed by a second CTC test at least 4 weeks later (PCWG3 2016) Up to 5 years following the start of treatment Secondary Outcome Measures Outcome Measure Measure Description Time Frame Overall survival From date of registration until the date of first documented date of death from any cause, assessed up to 5 years. Radiological progression free survival From registration to objective disease progression or death from any cause, whichever comes first, assessed up to 5 years PSA progression free survival From registration to PSA progression free survival assessed up to 5 years Change in patient reported outcome measures (NCI's PRO-CTCAE) From registration until 5 years post treatment Frequency and severity of adverse events For 24 months post the start of trial treatment Keywords Provided by University College, London Immunogenic signature Additional Relevant MeSH Terms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Prostatic Neoplasms Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Nivolumab Ipilimumab Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Product Manufactured in and Exported from the U.S. Yes Revision: v2.9.1'SummaryDifference39%
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