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Compares treatment options for Melanoma
Official title 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
ClinicalTrials.gov ID: NCT06797297
What this study is testing
What is IBI363?
IBI363 is an investigational medicine, being studied as a potential treatment for melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed unresectable, locally advanced or metastatic mucosal or acral-type melanoma, according to the American...
- No prior systemic treatment for unresectable or metastatic melanoma; Prior adjuvant or neoadjuvant therapy (except for disease progression to...
- Have at least one measurable lesion (target lesion) according to RECIST v1.1. For lesions that have previously received radiotherapy or intratumoral...
- The Eastern Cooperative Oncology Group Physical Status Score (ECOG PS) is 0 or 1.
- Expected survival time no less than 3 months.
You likely can't join if
- 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)...
- Any of the following serum biochemical abnormalities are present at baseline (within 7 days before the first dose) : Total bilirubin \>1.5× Upper...
- Any of the following coagulation parameters are abnormal at baseline (within 7 days before the first dose) : International normalizaed ratio (INR)...
- There is a history of active thrombosis or deep vein thrombosis or pulmonary embolism in the 4 weeks prior to initial administration of the...
See the full eligibility criteria
- 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...
- 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...
- The Eastern Cooperative Oncology Group Physical Status Score (ECOG PS) is 0 or 1.
- Expected survival time no less than 3 months.
- Female people of childbearing age or male people 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.
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Zhengzhou, Hena, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Baotou, Inner Mongolia, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.