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
- Registration Number
- NCT06797297
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
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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.
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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.
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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.
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The Eastern Cooperative Oncology Group Physical Status Score (ECOG PS) is 0 or 1.
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Expected survival time no less than 3 months.
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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.
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Breastfeeding women must agree to strictly refrain from breastfeeding during the entire treatment period and for 6 months after the treatment period.
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Women who are pregnant or plan to become pregnant within 6 months before, during, or after the last dose of the study drug.
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Active or symptomatic central nervous system metastases
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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
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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.
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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).
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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.
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Uncontrolled bleeding or a known tendency to bleed.
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Cardiovascular and cerebrovascular diseases of significant clinical significance.
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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.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: IBI363 IBI363 - Active Comparator: Pembrolizumab Pembrolizumab -
- Primary Outcome Measures
Name Time Method IRRC-Progression Free Survival(PFS) up to 2 years Progression Free Survival assessed by Independent Radiology Review Committee (IRRC-PFS), Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Secondary Outcome Measures
Name Time Method Disease Control Rate (DCR) up to 2 years DCR in two arms based on RECIST V1.1 by IRRC and investigator.
INV-Progression Free Survival(PFS) up to 2 years Progression Free Survival assessed by Investigator, Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Objective Response Rate (ORR) up to 2 years Objective response rate (ORR) in two arms based on RECIST V1.1 by IRRC and investigator.
Duration of Response (Duration Of Response) up to 2 years DOR in two arms based on RECIST V1.1 by IRRC and investigator.
Time to Response (TTR) up to 2 years TTR in two arms based on RECIST V1.1 by IRRC and investigator.
Overall Survival (OS) up to 2 years Overall survival in two arms
safety indicators during the treatment up to 2 years 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
Related Research Topics
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Trial Locations
- Locations (31)
Jiangsu Provincial People's Hospital
🇨🇳Nanjing, Jiangsu, China
First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Jishuitan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University Cancer Hospital & Institute, Beijing, China,
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Affiliated Tumor Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The Third people's hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Hena, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Xiangya Second Hospital of Central South University
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Baotou Cancer Hospital
🇨🇳Baotou, Inner Mongolia, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangxi Provincial Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
The first hospital of Jilin University
🇨🇳Changchun, Jilin, China
Liaoning Cancer Hospital
🇨🇳Shenyang, Liaoning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Shandong First Medical University Affiliated Cancer Hospital
🇨🇳Jinan, Shandong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, China
The Affiliated Cancer Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China