Clinical trial NCT06797297: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: IRRC-Progression Free Survival(PFS)
timeFrame: up to 2 years
Secondary outcomes:
measure: INV-Progression Free Survival(PFS)
timeFrame: up to 2 years
measure: Objective Response Rate (ORR)
timeFrame: up to 2 years
measure: Duration of Response (Duration Of Response)
timeFrame: up to 2 years
measure: Disease Control Rate (DCR)
timeFrame: up to 2 years
measure: Time to Response (TTR)
timeFrame: up to 2 years
measure: Overall Survival (OS)
timeFrame: up to 2 years
measure: safety indicators during the treatment
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Jishuitan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute, Beijing, China,
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: Affiliated Tumor Hospital of Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The Third people's hospital of Zhengzhou
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Hena
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Second Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Baotou
country: China
facility: Baotou Cancer Hospital
state: Inner Mongolia
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong First Medical University Affiliated Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Xi'an
country: China
facility: Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: