Actively Recruiting
Sintilimab Plus Chemotherapy Versus Chemotherapy Alone for PD-L1-Positive Resectable Mucosal Melanoma: A Randomized Phase II Trial
Led by The First Hospital of Jilin University · Updated on 2026-02-10
220
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Melanoma, particularly mucosal melanoma, is a rapidly increasing cancer in East Asia with significant incidence and mortality rates. This trial evaluates the combination of sintilimab and chemotherapy compared to chemotherapy alone for patients with PD-L1-positive mucosal melanoma that has been completely removed by surgery. The purpose is to gather more clinical evidence on the best adjuvant treatment options for this condition. Participants in this phase II study receive either sintilimab combined with chemotherapy or chemotherapy alone. Sintilimab is given intravenously every three weeks for six cycles followed by maintenance therapy for one year. Chemotherapy includes dacarbazine or temozolomide daily for five days plus cisplatin intravenously for three days every three weeks, administered over six cycles. This study is randomized with single masking and involves multiple centers. During the trial, participants undergo careful monitoring including imaging and physical exams to confirm no recurrence before treatment. Researchers assess recurrence-free survival over two years and overall survival over three years, along with treatment side effects. Safety is monitored up to 30 days after treatment ends. Participants are expected to comply with all visits and procedures throughout the study period, which extends up to several years for follow-up.
CONDITIONS
Brief Title
Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study procedures
- Histologically or cytologically confirmed mucosal melanoma fully resected with negative margins
- PD-L1 positive tissue specimen with CPS ≥ 1
- First study drug dose administered within 13 weeks after complete wound healing post-surgery
- Confirmed complete tumor resection by exam and imaging within 4 weeks before randomization
- Brain MRI showing no recurrence for at least 4 weeks after surgery or surgery plus radiotherapy if CNS metastasis
- Completed lymph node dissection and radiotherapy within 13 weeks before treatment start
- Age 18 years or older
- Expected survival of at least 12 weeks
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function based on recent lab tests
- Effective contraception use during and for 6 months after treatment for participants of childbearing potential
You will not qualify if you...
- Previous treatment with anti-PD-1 or anti-PD-L1 antibodies
- Prior use of interferon
- Unstable thyroid diseases (except stable hypothyroidism on hormone therapy)
- Participation in another clinical trial currently
- Use of immunosuppressive drugs within 4 weeks before study drug (with some exceptions)
- Receipt of live vaccines within 4 weeks before study drug or planned during study
- Major surgery or unhealed wounds within 4 weeks before study drug
- History of gastrointestinal perforation or fistulas within 6 months before study drug
- Prior systemic anticancer treatments (chemotherapy, targeted therapy, biologics)
- Active or recent autoimmune diseases (with some exceptions)
- Primary immunodeficiency or history of organ transplantation (except corneal)
- Severe lung diseases or impaired lung function
- Severe allergic reactions to monoclonal antibodies or interferons
- Uncontrolled fluid accumulation like pleural effusion or ascites
- HIV infection
- Active hepatitis B or C infection (with some exceptions)
- Active tuberculosis or severe infections
- Severe heart failure or uncontrolled arrhythmia
- Uncontrolled high blood pressure
- Recent serious arterial or venous thromboembolic events
- Uncontrolled metabolic or organ diseases increasing risk
- Liver failure or decompensated cirrhosis
- Recent serious gastrointestinal diseases or surgeries
- Other conditions or lab abnormalities increasing risk or interfering with study
- History of other primary cancers unless cured or low risk
- Pregnant or breastfeeding women
- Any other condition judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Approximately 18 weeks (6 cycles of treatment every 3 weeks)
Participants receive Sintilimab combined with chemotherapy or chemotherapy alone as adjuvant treatment after surgery.
6 treatment visits every 3 weeks
Duration - Up to 1 year of maintenance therapy with sintilimab every 3 weeks
Participants in the experimental group receive maintenance therapy with sintilimab after initial combination treatment.
Maintenance visits every 3 weeks for up to 1 year
Duration - Up to 3 years
Participants are monitored for recurrence and overall survival after completion of treatment.
Periodic follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
The first hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
Research Team
D
Di Wu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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