Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05539118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-09-14
First Post:
2022-08-17
Brief Title:
Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
Interferon-α1b IFN-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Patients With Advanced Unresectable Melanoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-08
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:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of recombinant human interferon-α1b IFN-α1b combined with toripalimab and anlotinib hydrochloride in patients with unresectable advanced melanoma This study consists of 2 phases Ib II Phase Ib will determine the recommended phase Ⅱ dose for anlotinib hydrochloride Phase II will evaluate the efficacy and safety of the triple combination regimens
Detailed Description:
This is a single-arm single-center Phase IbII trial to evaluate the efficacy and safety of the combination of recombinant human interferon α1b plus toripalimab and anlotinib hydrochloride in patients with unresectable Stage IIIc Stage IIId and Stage IV melanomaAJCC 8th Phase I is to evaluate the dose-limiting toxicities DLT and determine the recommended Phase II dose RP2D of anlotinib hydrochloride in patients with unresectable advanced melanoma receiving recombinant human interferon α1b 600ug QOD plus toripalimab 240mg Q3W Anlotinib hydrochloride will be given in a dose descending manner12mg- 10mg- 8mg In the phase II study 30 Phase II will enroll 30 patients The primary endpoint in the II phase is objective response rate ORR and progression-free survival PFS The second endpoint is disease control rate DCR clinical benefit rate CBR duration of response DOR and overall survivalOS The safety profile of this combined IFN-α1b toripalimabanlotinib hydrochloride regimen will be monitored during both phases Specifically phase Ib will evaluate dose-limiting toxicitiesDLT Phase II will evaluate the numbers and severity of toxicity per the Criteria for Adverse Events version 5 CTCAEv including but not limited to all adverse events AE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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