Clinical trial · Interventional
The Study of JS001 Compared to High-Dose Interferon In Patients With Mucosal Melanoma That Has Been Removed by Surgery
A Phase II Randomized, Control, Multi-center Study of Recombinant Humanized Anti-PD-1 mAb for Injection Compared to High-Dose Interferon In Patients With Mucosal Melanoma That Has Been Removed by Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study strategy was adjusted, and the company decided to terminate the study early
Summary
Brief summary (as posted)
This is a phase II randomized, control, multi-center study of recombinant humanized anti-PD-1 mAb for injection compared to high-Dose interferon in patients with mucosal melanoma that has been removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucosal Melanoma | Mucosal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high-dose recombinant interferon a-2B | Biological | — | UNRESOLVED |
| humanized anti-PD-1 monoclonal antibody Toripalimab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- humanized anti-PD-1monoclonal antibody
- description
- humanized anti-PD-1 monoclonal antibody is to be injected intravenously 3mg/kg Q2w until disease progresses or unacceptable tolerability occurs for 1 year (27 treatments)
- interventionNames
- Biological: humanized anti-PD-1 monoclonal antibody Toripalimab
- type
- ACTIVE_COMPARATOR
- label
- high-dose recombinant interferon a-2B
- description
- Patients receive 15\*10\^9 U/m2/d recombinant interferon a-2B intravenously on days 1-5. Treatment repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.Then patients receive 15\*10\^9 U/m2/d recombinant interferon a-2B intravenously three times weekly for 48 weeks.
- interventionNames
- Biological: high-dose recombinant interferon a-2B
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male and Female aged between 18 and 75 years are eligible; * It was confirmed by histopathology that it was a mucosal melanoma; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; * Complete excision of primary focal area, surgical incision; All patients must have disease-free status documented by a complete physical examination and imaging studies prior to registration; * No adjuvant therapy was received; * No treatment contraindication, peripheral blood, normal liver, kidney function and electrocardiogram are normal; WBC≥4.0×10\^9/L,PLT≥100×10\^9/L,Hgb≥90g/L; serum urea nitrogen, cr≤ULN; ALT,AST,TBI≤1.5\*ULN, * Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 12 months after the last dose of study drug; * FT3,FT4 and TSH is normal; * Must have read, understood, and provided written informed consent voluntarily. Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol. Exclusion Criteria: * Prior treatment with anti-PD-1/PD-L1/PD-L2 antibody; * Hypersensitivity to recombinant humanized anti-PD-1 monoclonal mAb or its components; * Skin melanoma, ocular melanoma, original unknown melanoma; * The primary lesion was incomplete; * The examination suggests that the tumor remains or metastases; * Pregnant or nursing;Women with fertility but not contraception; * There are severe acute infections that are not controlled;There is a suppurative and chronic infection, and the wound is deferrable; * Those who had serious heart disease; * Psychiatric medicines abuse without withdrawal, or history of psychiatric illness. * Patients with other tumor; * Participate in other clinical studies at the same time; * Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (\>500IU/ml); * Patients with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism or hypothyroidism; * Prior live vaccine therapy within past 4 weeks; * Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events
References
Publications (0)
Data not yet available