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
IBI363: a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.
Pembrolizumab: Pembrolizumab is a humanized monoclonal anti-PD1 antibody
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 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.
2. 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.
3. 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.
4. The Eastern Cooperative Oncology Group Physical Status Score (ECOG PS) is 0 or 1.
5. Expected survival time no less than 3 months.
6. 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.
7. Breastfeeding women must agree to strictly refrain from breastfeeding during the entire treatment period and for 6 months after the treatment period.
Exclusion Criteria:
1. Women who are pregnant or plan to become pregnant within 6 months before, during, or after the last dose of the study drug.
2. Active or symptomatic central nervous system metastases
3. 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
4. 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.
5. 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).
6. 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.
7. Uncontrolled bleeding or a known tendency to bleed.
8. Cardiovascular and cerebrovascular diseases of significant clinical significance.
9. 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.
10. 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.
Primary outcome measure(s)
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
Trial sites (31)
Facility
City
Region
Status
First Affiliated Hospital of Anhui Medical University
Hefei
Anhui
Recruiting
Beijing Jishuitan Hospital, Capital Medical University
Beijing
Beijing Municipality
Recruiting
Peking University Cancer Hospital & Institute, Beijing, China,
Beijing
Beijing Municipality
Recruiting
Chongqing University Cancer Hospital
Chongqing
Chongqing Municipality
Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
Affiliated Tumor Hospital of Guangxi Medical University
Nanning
Guangxi
Recruiting
Fourth Hospital of Hebei Medical University
Shijiazhuang
Hebei
Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Recruiting
The Third people's hospital of Zhengzhou
Zhengzhou
Henan
Recruiting
Henan Cancer Hospital
Zhengzhou
Hena
Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Recruiting
Xiangya Second Hospital of Central South University
Changsha
Hunan
Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Recruiting
Baotou Cancer Hospital
Baotou
Inner Mongolia
Recruiting
Jiangsu Provincial People's Hospital
Nanjing
Jiangsu
Recruiting
Nanjing Drum Tower Hospital
Nanjing
Jiangsu
Recruiting
Jiangxi Provincial Cancer Hospital
Nanchang
Jiangxi
Recruiting
Jilin Cancer Hospital
Changchun
Jilin
Recruiting
The first hospital of Jilin University
Changchun
Jilin
Recruiting
Liaoning Cancer Hospital
Shenyang
Liaoning
Recruiting
Qilu Hospital of Shandong University
Jinan
Shandong
Recruiting
Shandong First Medical University Affiliated Cancer Hospital
Jinan
Shandong
Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
Recruiting
Shanxi Bethune Hospital
Taiyuan
Shanxi
Recruiting
Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an
Shanxi
Recruiting
West China Hospital, Sichuan University
Chengdu
Sichuan
Recruiting
Tianjin Cancer Hospital
Tianjin
Tianjin Municipality
Recruiting
The Affiliated Cancer Hospital of Xinjiang Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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