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

April 1, 2025 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230088
        • Recruiting
        • First Affiliated Hospital of Anhui Medical University
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100035
        • Recruiting
        • Beijing Jishuitan Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital & Institute, Beijing, China,
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350000
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Affiliated Tumor Hospital of Guangxi Medical University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • Fourth Hospital of Hebei Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150030
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Hena
      • Zhengzhou, Hena, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450044
        • Recruiting
        • The Third People's Hospital of Zhengzhou
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410031
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Xiangya Second Hospital of Central South University
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • Recruiting
        • Baotou Cancer Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Jiangsu Provincial People's Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Recruiting
        • Jiangxi Provincial Cancer Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130012
        • Recruiting
        • Jilin cancer hospital
        • Contact:
      • Changchun, Jilin, China, 130012
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China, 250120
        • Recruiting
        • Shandong First Medical University Affiliated Cancer Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200035
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 30032
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
      • Xi'an, Shanxi, China, 710004
        • Recruiting
        • Second Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Cancer Hospital
        • Contact:
    • Xinjiang
      • Urumqi, Xinjiang, China, 830000
        • Recruiting
        • The Affiliated Cancer Hospital of Xinjiang Medical university
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650106
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: IBI363
Biological: IBI363
a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.
Active Comparator: Active Comparator: Pembrolizumab
Biological: Pembrolizumab
Pembrolizumab is a humanized monoclonal anti-PD1 antibody

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
IRRC-Progression Free Survival(PFS)
Time Frame: 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
up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
INV-Progression Free Survival(PFS)
Time Frame: up to 2 years
Progression Free Survival assessed by Investigator, Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
up to 2 years
Objective Response Rate (ORR)
Time Frame: up to 2 years
Objective response rate (ORR) in two arms based on RECIST V1.1 by IRRC and investigator.
up to 2 years
Duration of Response (Duration Of Response)
Time Frame: up to 2 years
DOR in two arms based on RECIST V1.1 by IRRC and investigator.
up to 2 years
Disease Control Rate (DCR)
Time Frame: up to 2 years
DCR in two arms based on RECIST V1.1 by IRRC and investigator.
up to 2 years
Time to Response (TTR)
Time Frame: up to 2 years
TTR in two arms based on RECIST V1.1 by IRRC and investigator.
up to 2 years
Overall Survival (OS)
Time Frame: up to 2 years
Overall survival in two arms
up to 2 years
safety indicators during the treatment
Time Frame: 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
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIBI363B202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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