This is a Phase II, open-label, randomized, multi-center study to assess the efficacy and safety of IBI363 monotherapy compared to Pembrolizumab in the treatment of patients with unresectable locally advanced or metastatic mucosal or acral melanoma who had not previously received systemic therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.
Pembrolizumab is a humanized monoclonal anti-PD1 antibody
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGBeijing Jishuitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPeking University Cancer Hospital & Institute, Beijing, China,
Beijing, Beijing Municipality, China
RECRUITINGChongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
IRRC-Progression Free Survival(PFS)
Progression Free Survival assessed by Independent Radiology Review Committee (IRRC-PFS), Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: up to 2 years
INV-Progression Free Survival(PFS)
Progression Free Survival assessed by Investigator, Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: up to 2 years
Objective Response Rate (ORR)
Objective response rate (ORR) in two arms based on RECIST V1.1 by IRRC and investigator.
Time frame: up to 2 years
Duration of Response (Duration Of Response)
DOR in two arms based on RECIST V1.1 by IRRC and investigator.
Time frame: up to 2 years
Disease Control Rate (DCR)
DCR in two arms based on RECIST V1.1 by IRRC and investigator.
Time frame: up to 2 years
Time to Response (TTR)
TTR in two arms based on RECIST V1.1 by IRRC and investigator.
Time frame: up to 2 years
Overall Survival (OS)
Overall survival in two arms
Time frame: up to 2 years
safety indicators during the treatment
Number of participants with Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Immune-related AE (irAE), Serious Adverse Event (SAE), treatment-emergent AE leading to treatment termination, death, and related with investigational agent
Time frame: up to 2 years
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Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGAffiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGFourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGThe Third people's hospital of Zhengzhou
Zhengzhou, Henan, China
RECRUITING...and 21 more locations