Mucosal MelanomaPhase 2NCT07400302
Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery
A Phase 2 study testing Sintilimab, Dacarbazine or Temozolomide and Cisplatin in people with Mucosal Melanoma and PD-L1 Positive, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucosal Melanoma, PD-L1 Positive
- What is being tested?
- Sintilimab, Dacarbazine or Temozolomide and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 30 Sep 2029
- 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
- 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 7 days due to unforeseen circumstances, the decision to enroll may be discussed with the medical monitor).
- 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 radiotherapy. Note: if immunosuppressants (e.g., prednisone) are required, they must be discontinued at least 14 days before the study drug administration.
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- 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: If delayed wound healing occurs due to radiotherapy, the subject will not meet the eligibility criteria.
- 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 corrective drugs should be given within 14 days prior to laboratory tests):
- Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelet Count (PLT) ≥ 90 × 10⁹/L; Hemoglobin (HGB) ≥ 9.0 g/dL (90 g/L).
- Liver Function: Total Bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN) (for patients suspected of or diagnosed with Gilbert's syndrome, TBIL ≤ 3 × ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN.
- Renal Function: Serum Creatinine (Scr) ≤ 1.5 × ULN, or Creatinine Clearance Rate (Ccr) ≥ 50 ml/min (calculated using the Cockcroft/Gault formula), and urinalysis showing urinary protein (UPRO) < 2+ or 24-hour urinary protein < 1g.(Cockcroft-Gault Formula) (4) Coagulation Function: International Normalized Ratio (INR) and Prothrombin Time (PT) ≤ 1.5 × ULN.
- 12. Female subjects of childbearing potential, or male subjects whose partners are women of childbearing potential, must use effective contraception throughout the treatment period and for 6 months after treatment.
Who cannot join
- 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 10 mg/day of prednisone or an equivalent dose of other corticosteroids).
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- 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 a 2-week washout period.
- Active, known, or suspected autoimmune diseases, or a history of autoimmune disease within the last 2 years (subjects with vitiligo, psoriasis, alopecia, or Grave's disease who did not require systemic treatment in the past 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type 1 diabetes requiring only insulin replacement therapy may be included).
- 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 eligible for inclusion.
- 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 considered "severe" thromboembolic events).
- 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 the patient is unsuitable for enrollment.
- 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 resection resulting in chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea within 6 months prior to enrollment.
- Other acute or chronic diseases, psychiatric disorders, or abnormal laboratory test results that may:
- Increase the risk related to participation in the study or study drug administration.
- Interfere with the interpretation of study results and lead the investigator to determine that the patient is ineligible for participation.
- 29. History of other primary malignancies, excluding:
- 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 unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The first hospital of Jilin University
Changchun, Jilin, 130000
Di Wu, MD, 86+13944888991, Wudi991202@163.com
About this study
Official title: A Randomized, Controlled, Multicenter Phase II Clinical Study Evaluating the Adjuvant Treatment of PD-L1-Positive, Resectable Mucosal Melanoma With Sintilimab Plus Chemotherapy Versus Chemotherapy Alone
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. Currently, immune checkpoint inhibitors are achieving significant breakthroughs in adjuvant melanoma therapy. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy alone in patients with PD-L1-positive, completely resectable mucosal melanoma, thereby providing additional clinical evidence for treatment decisions.
- Conditions
- Mucosal Melanoma, PD-L1 Positive
- Being tested
- Sintilimab, Dacarbazine or Temozolomide, Cisplatin
- Keywords
- Adjuvant Treatment, PD-L1-Positive, Resectable Mucosal Melanoma, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab 200 mg IV Q3W for 6 cycles. Followed by maintenance therapy with sintilimab 200 mg IV Q3W for 1 year.
Dacarbazine or TemozolomideDrug
Dacarbazine 250 mg/m² or Temozolomide 200 mg/m² QD D1-5 Q3W for 6 cycles.
CisplatinDrug
Cisplatin 75 mg/m² IV D1-3 Q3W, administered in combination for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group A | Experimental | Sintilimab, Dacarbazine or Temozolomide, Combined with Cisplatin Receives: Drug: Sintilimab; Drug: Dacarbazine or Temozolomide; Drug: Cisplatin |
| Experimental group B | Active comparator | Dacarbazine or Temozolomide, Combined with Cisplatin Receives: Drug: Dacarbazine or Temozolomide; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival
Measured: 2 years
Secondary outcomes (3)
2-year recurrence-free survival rate
Measured: 2 years
Overall Survival
Time from randomization to documented death from any cause.
Measured: 3 years
Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0.
Safety will be assessed in the Safety Set (SS), including all participants who received at least one dose of study medication. Assessments include the incidence and severity of adverse events, laboratory abnormalities (hematology, liver/kidney function), vital signs, ECG changes, and immunogenicity.
Measured: From the first dose of study treatment up to 30 days after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start10 Apr 2026
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal MelanomaStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400302
- Sponsor's protocol ID
- K2024390
- Status last verified
- Sep 2026
- First submitted
- 21 Jan 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Phase II Clinical Study Evaluating the Adjuvant Treatment of PD-L1-Positive, Resectable Mucosal Melanoma With Sintilimab Plus Chemotherapy Versus Chemotherapy Alone
- ClinicalTrials.gov ID
- NCT07400302
- Acronym / sponsor ID
- K2024390
- Conditions
- Mucosal Melanoma, PD-L1 Positive
- Keywords
- Adjuvant Treatment, PD-L1-Positive, Resectable Mucosal Melanoma, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Currently, immune checkpoint inhibitors are achieving significant breakthroughs in adjuvant melanoma therapy. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy alone in patients with PD-L1-positive, completely resectable mucosal melanoma, thereby providing additional clinical evidence for treatment decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group A | Experimental | Drug: Sintilimab, Drug: Dacarbazine or Temozolomide, Drug: CisplatinSintilimab, Dacarbazine or Temozolomide, Combined with Cisplatin |
| Experimental group B | Active comparator | Drug: Dacarbazine or Temozolomide, Drug: CisplatinDacarbazine or Temozolomide, Combined with Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 7 days due to unforeseen circumstances, the decision to enroll may be discussed with the medical monitor).
- Confirmed R0 complete resection by physical examination and imaging within 4 weeks prior to randomization.
Key exclusion criteria (35 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SintilimabSintilimab 200 mg IV Q3W for 6 cycles. Followed by maintenance therapy with sintilimab 200 mg IV Q3W for 1 year. | Drug | Experimental group A |
| Dacarbazine or TemozolomideDacarbazine 250 mg/m² or Temozolomide 200 mg/m² QD D1-5 Q3W for 6 cycles. | Drug | Experimental group A, Experimental group B |
| CisplatinCisplatin 75 mg/m² IV D1-3 Q3W, administered in combination for 6 cycles. | Drug | Experimental group A, Experimental group B |
Primary outcome
Recurrence Free Survival
Time frame: 2 years
3 secondary outcomes
2-year recurrence-free survival rate
Time frame: 2 years
Overall Survival
Time frame: 3 years
Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0.
Time frame: From the first dose of study treatment up to 30 days after the last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab, Dacarbazine or Temozolomide and Cisplatin in people with Mucosal Melanoma and PD-L1 Positive, run by The First Hospital of Jilin University at 1 site 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 15 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Di Wu, MD (86+13944888991, Wudi991202@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.