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
A Phase II, Open-label, Randomized, Multi-center Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal and Acral Melanoma Who Had Not Previously Received Systemic Therapy
1 other identifier
interventional
180
1 country
31
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2025
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2025
CompletedFirst Posted
Study publicly available on registry
January 28, 2025
CompletedStudy Start
First participant enrolled
February 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
ExpectedApril 4, 2025
April 1, 2025
1.1 years
January 22, 2025
April 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
up to 2 years
Secondary Outcomes (7)
INV-Progression Free Survival(PFS)
up to 2 years
Objective Response Rate (ORR)
up to 2 years
Duration of Response (Duration Of Response)
up to 2 years
Disease Control Rate (DCR)
up to 2 years
Time to Response (TTR)
up to 2 years
- +2 more secondary outcomes
Study Arms (2)
Experimental: IBI363
EXPERIMENTALActive Comparator: Pembrolizumab
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed unresectable, locally advanced or metastatic mucosal or acral-type melanoma, according to the American Joint Committee on Cancer (AJCC) 8th edition stage III-IV.
- No prior systemic treatment for unresectable or metastatic melanoma; Prior adjuvant or neoadjuvant therapy (except for disease progression to unresectable or metastatic melanoma during adjuvant or neoadjuvant therapy or within 6 months after treatment discontinuation) was permitted.
- Have at least one measurable lesion (target lesion) according to RECIST v1.1. For lesions that have previously received radiotherapy or intratumoral injection, measurable lesions that progress to the criteria specified in RECIST1.1 after treatment may be considered.
- The target lesions of this study must be measured by imaging (enhanced CT or MRI. Plain scan CT or MRI can be accepted after communication with the sponsor if the subjects are allergic to contrast media or have other conditions that are not suitable for enhanced CT or MRI).
- Skin lesions or other superficial sites that cannot be repeatedly measured by imaging can only be used as non-target lesions.
- The Eastern Cooperative Oncology Group Physical Status Score (ECOG PS) is 0 or 1.
- Expected survival time no less than 3 months.
- Female subjects of childbearing age or male subjects whose partner is a female of childbearing age agree to strictly use effective contraception throughout the treatment period and for 6 months after the treatment period.
- Breastfeeding women must agree to strictly refrain from breastfeeding during the entire treatment period and for 6 months after the treatment period.
You may not qualify if:
- Women who are pregnant or plan to become pregnant within 6 months before, during, or after the last dose of the study drug.
- Active or symptomatic central nervous system metastases
- Any of the following hematological abnormalities were present at baseline \* (within 7 days before the first administration of the study drug) :
- Hemoglobin \<90 g/L The absolute count of neutrophils (ANC) was \<1.5×10\^9/L Platelet count \<100×10\^9/L
- Any of the following serum biochemical abnormalities are present at baseline (within 7 days before the first dose) :
- Total bilirubin \>1.5× Upper limit of normal (ULN); Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>3×ULN; For liver metastasis, AST or ALT \> 5.0×ULN; With serum Creatinine \>1.5×ULN or Clearance of Creatinine (CCr) \<45 mL/min, CCr (using actual body weight) was calculated using Cockcroft-Gault formula (Appendix 3).
- Albumin \<30 g/L.
- Any of the following coagulation parameters are abnormal at baseline (within 7 days before the first dose) :
- International normalizaed ratio (INR) \>1.5×ULN (\>3×ULN if receiving steady dose anticoagulant therapy); Partial thromboplastin time (PTT) (or activated partial thromboplastin time, \[activated partial thromboplastin time, PTT) aPTT\]) \>1.5×ULN (\>3×ULN if receiving steady dose anticoagulant therapy).
- There is a history of active thrombosis or deep vein thrombosis or pulmonary embolism in the 4 weeks prior to initial administration of the investigatory drug, unless the disease is adequately treated and is considered stable by the investigator.
- Uncontrolled bleeding or a known tendency to bleed.
- Cardiovascular and cerebrovascular diseases of significant clinical significance.
- History of interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, drug-related pneumonia, radiation pneumonia, etc. requiring steroid hormone or other treatment, as well as severe abnormal lung function or other forms of restrictive lung disease.
- An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, corticosteroids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230088, China
Beijing Jishuitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100035, China
Peking University Cancer Hospital & Institute, Beijing, China,
Beijing, Beijing Municipality, 100142, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400000, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150030, China
The Third people's hospital of Zhengzhou
Zhengzhou, Henan, 450044, China
Henan Cancer Hospital
Zhengzhou, Hena, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Xiangya Second Hospital of Central South University
Changsha, Hunan, 410000, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
Baotou Cancer Hospital
Baotou, Inner Mongolia, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, 330000, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
The first hospital of Jilin University
Changchun, Jilin, 130012, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110000, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Shandong First Medical University Affiliated Cancer Hospital
Jinan, Shandong, 250120, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200035, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 30032, China
Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650106, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Participants are assigned to one of two groups in parallel for the duration of the study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2025
First Posted
January 28, 2025
Study Start
February 24, 2025
Primary Completion
March 31, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
April 4, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share