Ignite Creation Date:
2024-05-06 @ 4:19 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04949113
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2021-06-16
Brief Title:
Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
Multicenter Phase 3 Trial Comparing Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma - NADINA
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NADINA
Brief Summary:
This is an international Australia Europe and USA open-label two-arm randomized phase 3 trial including 420 stage III 3 resectable in-transit metastases allowed cutaneous or unknown primary melanoma patients Patients will be randomized 11 to receive either 2 cycles of neoadjuvant ipilimumab 80 mg nivolumab 240 mg every 3 weeks followed by a total lymph node dissection TLND and if applicable resection of in-transit metastases arm A versus standard upfront TLND - resection of in-transit metastases followed by 12 cycles adjuvant nivolumab 480 mg every 4 weeks arm B Patients with a pathologic partial or non-response in arm A will also receive adjuvant nivolumab 480 mg every 4 weeks for 46 weeks 11 cycles In case of BRAF V600EK mutation-positivity patients from arm A with a pathologic partial or non-response 10 viable tumor will be treated with adjuvant dabrafenib plus trametinib for 46 weeks Patients will be treated in the study in both arms until melanoma progression to irresectable stage III or stage IV disease disease recurrence unacceptable toxicity subject withdrawal of consent or until end of study treatment
An interim analysis will be performed after 60 events have occurred The data safety monitory board DSMB will be ad hoc consulted when unexpected toxicities are reported Patients will be followed by 12 weekly CT scans until end of year 3 and then until year 5 according to the institutes standards
An interim analysis will be performed after 60 events have occurred The data safety monitory board DSMB will be ad hoc consulted when unexpected toxicities are reported Patients will be followed by 12 weekly CT scans until end of year 3 and then until year 5 according to the institutes standards
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA209-6FR | OTHER | BMS | None |