Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery

NCT07400302 | Recruiting Phase 2

• 1 other identifier: K2024390
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Adjuvant Treatment; PD-L1-Positive; Resectable Mucosal Melanoma; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Survival

  2 years

Secondary Outcomes (3)

• 2-year recurrence-free survival rate

  2 years

• Overall Survival

  3 years

• Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0.

  From the first dose of study treatment up to 30 days after the last dose.

Study Arms (2)

Experimental group A

EXPERIMENTAL

Sintilimab, Dacarbazine or Temozolomide, Combined with Cisplatin

Drug: Sintilimab; Drug: Dacarbazine or Temozolomide; Drug: Cisplatin

Experimental group B

ACTIVE COMPARATOR

Dacarbazine or Temozolomide, Combined with Cisplatin

Drug: Dacarbazine or Temozolomide; Drug: Cisplatin

Interventions

Sintilimab DRUG

Sintilimab 200 mg IV Q3W for 6 cycles. Followed by maintenance therapy with sintilimab 200 mg IV Q3W for 1 year.

Experimental group A

Dacarbazine or Temozolomide DRUG

Dacarbazine 250 mg/m² or Temozolomide 200 mg/m² QD D1-5 Q3W for 6 cycles.

Experimental group A; Experimental group B

Cisplatin DRUG

Cisplatin 75 mg/m² IV D1-3 Q3W, administered in combination for 6 cycles.

Experimental group A; Experimental group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.
• 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):
• (1) Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelet Count (PLT) ≥ 90 × 10⁹/L; Hemoglobin (HGB) ≥ 9.0 g/dL (90 g/L).
• (2) 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.
• (3) 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.
• \. 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.

You may not qualify 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 or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg/day of prednisone or an equivalent dose of other corticosteroids).
• 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).

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Interventions

sintilimab; Dacarbazine; Temozolomide; Cisplatin

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Di Wu, MD

CONTACT

86+13944888991; Wudi991202@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 10, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: February 10, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)