Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT05539118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-09-14
First Post:
2022-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma
Sponsor:
Xijing Hospital
Organization:
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 Ib/II 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 melanoma(AJCC 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 manner(12mg- 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 survival(OS). The safety profile of this combined IFN-α1b/ toripalimab/anlotinib hydrochloride regimen will be monitored during both phases. Specifically, phase Ib will evaluate dose-limiting toxicities(DLT). 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?: