Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-27 @ 7:38 AM
Study NCT ID:
NCT04464759
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2020-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma
Sponsor:
Ravi Amaravadi, MD
Organization:
Study Overview
Official Title:
LIMIT Melanoma: (Lysosomal Inhibition + Melanoma ImmunoTherapy) A Phase 1/2 Open Label Trial of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Patients With Advanced Melanoma
Status:
RECRUITING
Status Verified Date:
2025-07
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:
LIMIT
Brief Summary:
This study will evaluate the safety, tolerability and efficacy (objective response rate) of using hydroxychloroquine (HCQ) in combination with nivolumab and ipilimumab or with nivolumab alone in subjects with advanced/metastatic melanoma.
Detailed Description:
There are three parts to this Phase 1/2 study in subjects with advanced melanoma:
Phase 1a will identify the MTD and preliminary safety of combination hydroxychloroquine and nivolumab therapy.
Phase 1b will identify the MTD and preliminary safety of hydroxychloroquine administered in conjunction with nivolumab and ipilimumab therapy
Phase 2 will assess the clinical efficacy of combination hydroxychloroquine and nivolumab therapy.
Phase 1a will identify the MTD and preliminary safety of combination hydroxychloroquine and nivolumab therapy.
Phase 1b will identify the MTD and preliminary safety of hydroxychloroquine administered in conjunction with nivolumab and ipilimumab therapy
Phase 2 will assess the clinical efficacy of combination hydroxychloroquine and nivolumab therapy.
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IRB#835033 | OTHER | University of Pennsylvania | View |