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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06424626
Other study ID # AK104-IIT-043
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date May 21, 2024
Est. completion date December 31, 2027

Study information

Verified date December 2023
Source Peking University Cancer Hospital & Institute
Contact Lu Si, MD
Phone +86(10)88196951
Email silu.net@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was a phase IB, single-center, open-label, two part(part 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.


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 1.1 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 1.1 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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AK104+Axitinib
Subjects receive AK104 10mg/kg intravenously (IV) every 3-week cycle plus Axitinib until progression.
AK112+Axitinib
Subjects receive AK112 20mg/kg intravenously (IV) every 3-week cycle plus Axitinib until progression.

Locations

Country Name City State
China Beijing Cancer Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Safety assessments including vital signs, laboratory tests, and adverse event monitoring 3 years
Secondary Objective Response Rate (ORR) by irRC and RECIST 1.1 The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine tumor response. 3 years
Secondary Duration of Response (DOR) by irRC and RECIST 1.1 The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine duration of response. 3 years
Secondary Disease Control Rate (DCR) by irRC and RECIST 1.1 The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine disease control rate. 3 years
Secondary Time to response (TTR) by irRC and RECIST 1.1 The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine time to response. 3 years
Secondary Progression-free survival(PFS) by irRC and RECIST 1.1 The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine progression-free survival time. 3 years
Secondary Overall survival (OS) by irRC and RECIST 1.1 The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine overall survival. 3 years
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