Evaluating IBI363 versus Pembrolizumab for advanced melanoma treatment

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

This study is testing whether a new treatment called IBI363 is better than Pembrolizumab for people with advanced melanoma that can't be surgically removed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Drugs / interventions: radiation, Pembrolizumab
• Locations: 31 sites (Hefei, Anhui and 30 other locations)
• Trial ID: NCT06797297 on ClinicalTrials.gov

What this trial studies

This Phase II, open-label, randomized, multi-center study aims to assess the efficacy and safety of IBI363 monotherapy compared to Pembrolizumab in patients with unresectable locally advanced or metastatic mucosal or acral melanoma. Participants must not have received any prior systemic therapy for their condition. The study will measure the response of at least one target lesion using imaging techniques according to established criteria. The goal is to determine which treatment provides better outcomes for this patient population.

Who should consider this trial

Good fit: Ideal candidates are patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not undergone any prior systemic treatment.

Not a fit: Patients with resectable melanoma or those who have previously received systemic therapy for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced melanoma who have not previously received systemic therapy.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this novel treatment comparison.

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.

Where this trial is running

Hefei, Anhui and 30 other locations

• First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
• Beijing Jishuitan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Peking University Cancer Hospital & Institute, Beijing, China, — Beijing, Beijing Municipality, China (Recruiting)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Affiliated Tumor Hospital of Guangxi Medical University — Nanning, Guangxi, China (Recruiting)
• Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Recruiting)
• The Third people's hospital of Zhengzhou — Zhengzhou, Henan, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Hena, China (Recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Xiangya Second Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• Baotou Cancer Hospital — Baotou, Inner Mongolia, China (Recruiting)
• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
• Jiangxi Provincial Cancer Hospital — Nanchang, Jiangxi, China (Recruiting)
• Jilin Cancer Hospital — Changchun, Jilin, China (Recruiting)
• The first hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Liaoning Cancer Hospital — Shenyang, Liaoning, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Shandong First Medical University Affiliated Cancer Hospital — Jinan, Shandong, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)
• Second Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Tianjin Cancer Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• The Affiliated Cancer Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xiuzhi Yu

Conditions Melanoma