Health TrialsbyHealthPanel

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

ConditionsMucosal MelanomaPD-L1 Positive
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Hospital of Jilin University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sintilimab

    Drug

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

  • Dacarbazine or Temozolomide

    Drug

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

  • Cisplatin

    Drug

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

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Experimental group AExperimental treatment 3 interventions
Group B: Experimental group BActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Recurrence Free Survival

Time frame
2 years

Secondary outcomes

1

2-year recurrence-free survival rate

Time frame
2 years
2

Overall Survival

Time from randomization to documented death from any cause.

Time frame
3 years
3

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Hospital of Jilin University

Lead sponsor

Source ClinicalTrials.gov
Apply now