Actively Recruiting
A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-04-04
180
Participants Needed
31
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed unresectable, locally advanced or metastatic mucosal or acral-type melanoma at AJCC 8th edition stage III-IV
- No prior systemic treatment for unresectable or metastatic melanoma; prior adjuvant or neoadjuvant therapy allowed except when disease progressed during or within 6 months after treatment
- At least one measurable lesion by imaging (enhanced CT or MRI) according to RECIST v1.1
- Eastern Cooperative Oncology Group Physical Status Score (ECOG PS) of 0 or 1
- Expected survival time of at least 3 months
- Female subjects of childbearing age or male subjects with female partners of childbearing age agree to use effective contraception throughout treatment and for 6 months after
- Breastfeeding women agree to abstain from breastfeeding during treatment and for 6 months after
You will not qualify if you...
- Women who are pregnant or plan to become pregnant within 6 months before, during, or after the last study drug dose
- Active or symptomatic central nervous system metastases
- Hemoglobin less than 90 g/L, neutrophils count less than 1.5 x 10^9/L, or platelet count less than 100 x 10^9/L at baseline
- Serum biochemical abnormalities: total bilirubin above 1.5 times ULN; AST or ALT above 3 times ULN (or 5 times ULN with liver metastasis); serum creatinine above 1.5 times ULN or creatinine clearance below 45 mL/min
- Albumin less than 30 g/L
- Abnormal coagulation parameters: INR above 1.5 times ULN (or 3 times ULN if on anticoagulants); PTT or aPTT above 1.5 times ULN (or 3 times ULN if on anticoagulants)
- History of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4 weeks unless stable and treated
- Uncontrolled bleeding or known bleeding tendency
- Significant cardiovascular or cerebrovascular disease
- History of lung diseases requiring steroids or other treatment, or severe abnormal lung function
- Active autoimmune disease requiring systemic treatment within 2 years prior to first administration, except replacement therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230088
Actively Recruiting
2
Beijing Jishuitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100035
Actively Recruiting
3
Peking University Cancer Hospital & Institute, Beijing, China,
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
4
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
5
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
6
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
7
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
8
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
9
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150030
Actively Recruiting
10
The Third people's hospital of Zhengzhou
Zhengzhou, Henan, China, 450044
Actively Recruiting
11
Henan Cancer Hospital
Zhengzhou, Hena, China
Actively Recruiting
12
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
13
Xiangya Second Hospital of Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
14
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Actively Recruiting
15
Baotou Cancer Hospital
Baotou, Inner Mongolia, China
Actively Recruiting
16
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
17
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
18
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, China, 330000
Actively Recruiting
19
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Actively Recruiting
20
The first hospital of Jilin University
Changchun, Jilin, China, 130012
Actively Recruiting
21
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110000
Actively Recruiting
22
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
23
Shandong First Medical University Affiliated Cancer Hospital
Jinan, Shandong, China, 250120
Actively Recruiting
24
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200035
Actively Recruiting
25
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 30032
Actively Recruiting
26
Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710004
Actively Recruiting
27
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
28
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
29
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830000
Actively Recruiting
30
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650106
Actively Recruiting
31
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xiuzhi Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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