AzTrials
AzTrials

MelanomaPhase 2NCT06797297

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

A Phase 2 study testing IBI363 and Pembrolizumab in people with Melanoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 31 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
IBI363 and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
31 sitesChina
Study dates
24 Feb 2025to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • 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.
  • The Eastern Cooperative Oncology Group Physical Status Score (ECOG PS) is 0 or 1.
Show all 9Show fewer
  • Expected survival time no less than 3 months.
  • 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.
  • Breastfeeding women must agree to strictly refrain from breastfeeding during the entire treatment period and for 6 months after the treatment period.

Who cannot join

  • Women who are pregnant or plan to become pregnant within 6 months before, during, or after the last dose of the study drug.
  • Active or symptomatic central nervous system metastases
  • 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
  • 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).
Show all 14Show fewer
  • Albumin <30 g/L.
  • 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).
  • 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.
  • Uncontrolled bleeding or a known tendency to bleed.
  • Cardiovascular and cerebrovascular diseases of significant clinical significance.
  • 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.
  • 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.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • Baotou Cancer Hospital

    Baotou, Inner Mongolia

  • Beijing Jishuitan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100035

  • Peking University Cancer Hospital & Institute, Beijing, China,

    Beijing, Beijing Municipality, 100142

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • The first hospital of Jilin University

    Changchun, Jilin, 130012

  • Xiangya Second Hospital of Central South University

    Changsha, Hunan, 410000

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400000

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350000

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150030

  • First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230088

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Shandong First Medical University Affiliated Cancer Hospital

    Jinan, Shandong, 250120

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650106

  • Jiangxi Provincial Cancer Hospital

    Nanchang, Jiangxi, 330000

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210000

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210000

  • Affiliated Tumor Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200035

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110000

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 30032

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

  • Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710004

  • The Third people's hospital of Zhengzhou

    Zhengzhou, Henan, 450044

  • Henan Cancer Hospital

    Zhengzhou, Hena

Other trials in China

About this study

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

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.

Conditions
Melanoma
Being tested
IBI363, Pembrolizumab
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI363Biological

    a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.

  • PembrolizumabBiological

    Pembrolizumab is a humanized monoclonal anti-PD1 antibody

Study groups in NCT06797297
Study groupRoleWhat they receive
Experimental: IBI363ExperimentalNot described
Receives: Biological: IBI363
Active Comparator: PembrolizumabActive comparatorNot described
Receives: Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IRRC-Progression Free Survival(PFS)

    Progression Free Survival assessed by Independent Radiology Review Committee (IRRC-PFS), Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: up to 2 years

Secondary outcomes (7)

  1. INV-Progression Free Survival(PFS)

    Progression Free Survival assessed by Investigator, Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: up to 2 years

  2. Objective Response Rate (ORR)

    Objective response rate (ORR) in two arms based on RECIST V1.1 by IRRC and investigator.

    Measured: up to 2 years

  3. Duration of Response (Duration Of Response)

    DOR in two arms based on RECIST V1.1 by IRRC and investigator.

    Measured: up to 2 years

  4. Disease Control Rate (DCR)

    DCR in two arms based on RECIST V1.1 by IRRC and investigator.

    Measured: up to 2 years

  5. Time to Response (TTR)

    TTR in two arms based on RECIST V1.1 by IRRC and investigator.

    Measured: up to 2 years

  6. Overall Survival (OS)

    Overall survival in two arms

    Measured: up to 2 years

  7. safety indicators during the treatment

    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

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2025
  2. Study start24 Feb 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06797297
Sponsor's protocol ID
CIBI363B202
Status last verified
Oct 2026
First submitted
22 Jan 2025
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IBI363 and Pembrolizumab in people with Melanoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IRRC-Progression Free Survival(PFS) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06797297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in