Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566391
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Ipilimumab and Nivolumab Followed by Adjuvant Nivolumab in Locally Advanced or Limited Metastatic Melanoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Primary Ipilimumab and Nivolumab Combo-immunotherapy Followed by Adjuvant Nivolumab in Locally Advanced or Limited Metastatic Melanoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is open label single arm study for pts with stage IIIB-IV melanoma accordingly with AJCC staging criteria 8th ed with potentially resectable disease Patients will receive every three weeks four cycles of Nivolumab 3 mgkg over one 30 minutes infusion and Ipilimumab 1 mgkg over 30 minutes infusion with a 30 minute break between each infusion Surgery will be performed after 4-6 weeks from the last dose After 4-6 weeks from surgery patients will receive Nivolumab 480 mg over one 60 minutes infusion every four weeks for six cycles
The duration of the trial is expected to be 12 months of accrual and approximately 24 months of follow-up after the end of adjuvant therapy
The duration of the trial is expected to be 12 months of accrual and approximately 24 months of follow-up after the end of adjuvant therapy
Detailed Description:
The study begins by establishing the patients initial eligibility and signing of the ICF Blood samples and tumor tissue obtained from core biopsy must be provided for biomarker analyses
All patients will receive every three weeks cycles of combined Nivolumab 3 mgkg and Ipilimumab 1 mgkg sequential for a total of four doses Nivolumab and Ipilimumab will be administered sequentially as two separate infusions one 30 minute Nivolumab infusion and one 30 minute Ipilimumab infusion with a 30 minute break between each infusion
Surgery will be performed on Week 12-16 on known disease sites and in absence of G2-3-4 AE
The Adjuvant treatment will be performed on Week 16-22 from surgery it will consist in Nivolumab 480 mg over one 60 minutes infusion every four weeks for six cycles
The Follow-up period will start 4 weeks after the end of adjuvant therapy Patients will be followed for 24 months
All patients will receive every three weeks cycles of combined Nivolumab 3 mgkg and Ipilimumab 1 mgkg sequential for a total of four doses Nivolumab and Ipilimumab will be administered sequentially as two separate infusions one 30 minute Nivolumab infusion and one 30 minute Ipilimumab infusion with a 30 minute break between each infusion
Surgery will be performed on Week 12-16 on known disease sites and in absence of G2-3-4 AE
The Adjuvant treatment will be performed on Week 16-22 from surgery it will consist in Nivolumab 480 mg over one 60 minutes infusion every four weeks for six cycles
The Follow-up period will start 4 weeks after the end of adjuvant therapy Patients will be followed for 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None