Ignite Creation Date:
2024-05-06 @ 12:48 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03853317
Status:
TERMINATED
Last Update Posted:
2023-06-28
First Post:
2019-02-14
Brief Title:
QUILT-3063 A Study of N-803 haNK and Avelumab in Patients With Merkel Cell Carcinoma That Has Progressed After Checkpoint Therapy
Sponsor:
ImmunityBio Inc
Organization:
ImmunityBio Inc
Study Overview
Official Title:
QUILT-3063 A Phase 2 Study of Combination Therapy With an IL-15 Superagonist N-803 Off-the-shelf CD16-targeted Natural Killer Cells haNK and Avelumab Without Cytotoxic Chemotherapy in Subjects With Merkel Cell Carcinoma MCC That Has Progressed on or After Treatment With a Checkpoint Inhibitor
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not meeting recruitment goal
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 2 single-arm study to evaluate combination therapy of avelumab haNK and N-803 in patients with Merkel Cell Carcinoma who have progressed on or after checkpoint inhibitor therapy as assessed by ORR Patients will receive treatment for a maximum of two years
Detailed Description:
This is a phase II single-arm study of combination therapy of avelumab haNK and N-803 in patients with Merkel Cell Carcinoma who have progressed on or after checkpoint inhibitor therapy as assessed by ORR Patients must have progressed on or within six months of completing treatment with either avelumab or pembrolizumab Patients will received treatment for a maximum of two years with avelumab and haNK administered every two weeks and N-803 administered every three weeks Radiologic evaluation will occur every eight weeks during the first year of treatment and every twelve weeks during the second year of treatment
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?:
None
Is an FDA AA801 Violation?:
None