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New treatment option for Mucosal Melanoma
Official title Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery
ClinicalTrials.gov ID: NCT07400302
What this study is testing
What is Sintilimab?
Sintilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mucosal 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
- Melanoma has emerged as the fastest-growing malignancy in recent years, with incidence and mortality rates among both men and women in East Asian countries exceeding the Asian average. China ranks fifth among East Asian nations in melanoma incidence.
- Phase 2: a mid-size study of how well it works
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
- Sign a written informed consent form (Informed Consent, ICF) and be able to comply with the visit schedule and related procedures outlined in the...
- Histologically/cytologically confirmed mucosal melanoma, with primary and/or metastatic lesions completely resected, with negative surgical margins.
- Tissue specimen: PD-L1 positive (CPS ≥ 1).
- The first dose of the study drug must be administered only after the melanoma resection wound has fully healed, and the injection time must not...
- Confirmed R0 complete resection by physical examination and imaging within 4 weeks prior to randomization.
You likely can't join if
- Previous exposure to any anti-PD-1 or anti-PD-L1/2 antibody.
- Previous use of interferon.
- Hyperthyroidism or hypothyroidism. Note: Hypothyroid patients whose condition is stable after hormone replacement therapy may be included.
- Concurrent participation in another clinical trial.
- Receipt of any investigational drug within 4 weeks before the first dose of the study drug.
- Use of immunosuppressive drugs within 4 weeks prior to the first dose of the study drug, excluding nasal, inhaled, or other topical corticosteroids...
See the full eligibility criteria
Who can join
- Sign a written informed consent form (Informed Consent, ICF) and be able to comply with the visit schedule and related procedures outlined in the protocol.
- Histologically/cytologically confirmed mucosal melanoma, with primary and/or metastatic lesions completely resected, with negative surgical margins.
- Tissue specimen: PD-L1 positive (CPS ≥ 1).
- The first dose of the study drug must be administered only after the melanoma resection wound has fully healed, and the injection time must not exceed 13 weeks post-surgery (if the time limit is exceeded by no more than...
- Confirmed R0 complete resection by physical examination and imaging within 4 weeks prior to randomization.
- For central nervous system (CNS) metastasis, post-surgical resection may receive adjuvant radiotherapy as needed. MRI of the brain must show no recurrence for at least 4 weeks after surgery or surgery combined with...
- If lymph node dissection combined with local radiotherapy is required after melanoma resection, radiotherapy must be completed within 13 weeks of lymph node dissection and before the start of adjuvant treatment. Note...
- Age ≥ 18 years.
- Expected survival ≥ 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
- Sufficient organ and bone marrow function, with laboratory values meeting the following criteria within 7 days before enrollment (no blood components, cell growth factors, albumin, or other intravenous or subcutaneous...
What rules you out
- Previous exposure to any anti-PD-1 or anti-PD-L1/2 antibody.
- Previous use of interferon.
- Hyperthyroidism or hypothyroidism. Note: Hypothyroid patients whose condition is stable after hormone replacement therapy may be included.
- Concurrent participation in another clinical trial.
- Receipt of any investigational drug within 4 weeks before the first dose of the study drug.
- Use of immunosuppressive drugs within 4 weeks prior to the first dose of the study drug, excluding nasal, inhaled, or other topical corticosteroids or systemic corticosteroids at physiological doses (i.e., not exceeding...
- Receipt of live attenuated vaccines within 4 weeks before the first dose of the study drug or planned use during the study.
- Major surgery (e.g., craniotomy, thoracotomy, or laparotomy) or any unhealed wounds, ulcers, or fractures within 4 weeks before the first dose of the study drug.
- History of gastrointestinal perforation and/or fistulas within 6 months prior to the first dose of the study drug.
- Previous systemic anticancer treatment (e.g., chemotherapy, targeted therapy, or biologics). Chinese herbal medicine with anticancer indications or immunomodulatory drugs (e.g., thymosin, interleukins) are allowed after...
- Active, known, or suspected autoimmune diseases, or a history of autoimmune disease within the last 2 years (people with vitiligo, psoriasis, alopecia, or Grave's disease who did not require systemic treatment in the...
- Known history of primary immunodeficiency.
- Known history of organ transplantation (except corneal transplant) or hematopoietic stem cell transplant.
- History of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, or any pulmonary diseases with severe impairment of lung function.
- Known history of severe allergic reactions to other monoclonal antibodies or interferons, or to any ingredient in the study drug (e.g., sintilimab or interferon).
- Clinically uncontrolled third-space fluid accumulation, such as pleural effusion or ascites that cannot be controlled by drainage or other methods before enrollment.
- HIV infection (HIV antibody positive).
- Acute or chronic active hepatitis B (HBV DNA copy number ≥ 1 × 10³ copies/ml or ≥ 200 IU/ml) or acute or chronic active hepatitis C (HCV antibody positive); patients with HCV antibody positive but RNA negative are...
- Active pulmonary tuberculosis.
- Active or clinically uncontrolled severe infections.
- Symptomatic congestive heart failure (NYHA Class III-IV) or symptomatic or uncontrolled arrhythmia.
- Uncontrolled hypertension despite appropriate treatment (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
- Any arterial thromboembolic event (e.g., myocardial infarction, unstable angina, pulmonary embolism, cerebral embolism) within 6 months before enrollment.
- History of deep vein thrombosis or any other severe thromboembolic event within 3 months before enrollment (implanted venous infusion ports or catheter-related thrombosis or superficial vein thrombosis are not...
- Uncontrolled metabolic disorders or other non-malignant organ/systemic diseases or cancer sequelae that would increase medical risks and/or create uncertainties in survival prognosis, and the investigator judges that...
- Hepatic encephalopathy, hepatorenal syndrome, or decompensated cirrhosis (Child-Pugh Class B or C).
- History of gastrointestinal perforation and/or fistulae, bowel obstruction (including incomplete bowel obstruction requiring parenteral nutrition), extensive bowel resection (e.g., partial colon or extensive small bowel...
- Other acute or chronic diseases, psychiatric disorders, or abnormal laboratory test results that may: (1) Increase the risk related to participation in the study or study drug administration. (2) Interfere with the...
- Malignancies that have been cured with no evidence of active disease for at least 5 years prior to enrollment, with a very low risk of recurrence.
- Non-melanoma skin cancer or malignant lentigo maligna with no evidence of disease recurrence after sufficient treatment.
- In situ carcinoma that has been treated sufficiently with no evidence of recurrence. 30\. Pregnant or breastfeeding female patients. 31. Other conditions that, according to the investigator's judgment, make the patient...
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.