Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03167164
Status:
WITHDRAWN
Last Update Posted:
2021-03-19
First Post:
2017-05-23
Brief Title:
QUILT-3045 NANT Merkel Cell Carcinoma MCC Vaccine Combination Immunotherapy in Subjects With MCC Who Have Progressed on or After PD-L1 Therapy
Sponsor:
ImmunityBio Inc
Organization:
ImmunityBio Inc
Study Overview
Official Title:
NANT Merkel Cell Carcinoma MCC Vaccine Combination Immunotherapy in Subjects With MCC Who Have Progressed on or After Anti-programmed Death-ligand 1 PD-L1 Therapy
Status:
WITHDRAWN
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial not initiated
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 1b2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with MCC who have progressed on or after anti-PD-L1 therapy
Detailed Description:
Treatment will be administered in two phases Subjects will continue treatment until they experience progressive disease PD or experience unacceptable toxicity not correctable with dose reduction withdraw consent or if the investigator feels it is no longer in the subjects best interest to continue treatment Those who have a complete response CR will enter phase 2 of the study Subjects may remain on phase 2 of the study for up to 1 year Treatment will continue in phase 2 until the subject experiences PD or unacceptable toxicity not correctable with dose reduction withdraws consent or if the investigator feels it is no longer in the subjects best interest to continue 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