Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424626
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
A Trial of AK104 or AK112 in Combination With Axitinib in Patients With Metastatic Mucosal Melanoma
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
A Phase Ib Open Mono-center Dose-reduction Tolerability Study of AK104 or AK112 in Combination With Axitinib in Patients With Metastatic Mucosal Melanoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
This study was a phase IB single-center open-label two partpart A involved dose reduction and part B involved cohort expansion clinical trial evaluating the safety and clinical activity of AK104 or AK112 in combination with axitinib in patients with advanced mucosal melanoma
Detailed Description:
The planned cohorts in part A were axitinib 5mg twice a day plus AK104 or AK112 every 3 weeks A minimum of three patients were initially enrolled at the first dose level If a dose-limiting toxicity occurred then the cohort would be expanded to a total of six patients Responses were evaluated by investigators using both RECIST version 11 and Immune-Related RECIST irRECIST Patients with progressive disease or an intolerant toxicity were taken off the study Patients who initially developed progressive disease per RECIST version 11 were allowed to continue therapy if the investigator considered patients to be benefiting from the treatment per irRECIST Any dose-reduction cohort that did not exceed the maximum-tolerated dose could be expanded in part B for additional evaluation of safety and clinical activity The primary end point of this study was dose-limiting toxicity within the first 4 weeks of treatment with AK104 or AK112 plus axitinib in part A
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