TerminatedNCT03178123Updated Jul 27, 2026

The Study of JS001 Compared to High-Dose Interferon In Patients With Mucosal Melanoma That Has Been Removed by Surgery

A Phase 2 interventional study of humanized anti-PD-1 monoclonal antibody Toripalimab and high-dose recombinant interferon a-2B in Mucosal Melanoma, sponsored by Shanghai Junshi Bioscience Co., Ltd.. Terminated at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Shanghai Junshi Bioscience Co., Ltd. · Phase 2, Interventional, and Treatment

Why this study was terminated

The study strategy was adjusted, and the company decided to terminate the study early

Phase: Phase 2
Study type: Interventional
Enrollment: 6
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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.

Read the detailed description

This is a multi-centre，open, randomized, parallel-group study of mucosal melanoma adjuvant therapy to evaluate the efficacy 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.There will be 220 subjects enrolling the study, and randomized 1:1 grouped into recombinant humanized anti-PD-1 mAb for injection group (experimental group) or interferon group (control group).Each group will have 110 subjects.Random stratification factor is the disease stage (I vs II vs III).The whole research lasts about 60 months.

Conditions studied

Mucosal Melanoma

Keywords

anti-PD-1 monoclonal antibody
Mucosal Melanoma
Interferons

In context

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd. is the lead sponsor of 98 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 6 participants (actual)

Study arms

Experimental
humanized anti-PD-1monoclonal antibody
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)
Biological: humanized anti-PD-1 monoclonal antibody Toripalimab
Active comparator
high-dose recombinant interferon a-2B
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.
Biological: high-dose recombinant interferon a-2B

Interventions

Biologicalhumanized anti-PD-1 monoclonal antibody Toripalimab
humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
Also known as: JS001, TAB001
Biologicalhigh-dose recombinant interferon a-2B
15\*10\^9 U/m2/d recombinant interferon a-2B intravenously on days 1-5 weekly for 4 weeks.Then 15\*10\^9 U/m2/d recombinant interferon a-2B intravenously three times weekly for 48 weeks.
Also known as: Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B, Intron A

What researchers measure

Primary outcomes

Recurrence-free survival rate
to evaluate the Recurrence free survival (RFS) of the patients with mucosal melanoma treated by JS001 and high-Dose interferon
Time frame: 5 years

Secondary outcomes

Distant metastases-free survival
to evaluate the distant metastases-free survival of the patients with mucosal melanoma treated by JS001 and high-Dose interferon
Time frame: 5 years
recurrence - free survival rate at 3 years
to evaluate the recurrence - free survival rate at 3 years of the patients with mucosal melanoma treated by JS001 and high-Dose interferon
Time frame: 3 years
Overall survival (OS)
to evaluate the Overall survival (OS) of the patients with mucosal melanoma treated by JS001 and high-Dose interferon
Time frame: 5 years
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 5 years

Study locations

1 site

Beijing Cancer Hospital
Beijing, Beijing Municipality 100142, China

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03178123
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Responsible party: Sponsor
First posted: Jun 6, 2017
Start date: May 31, 2017
Primary completion: Jun 30, 2019
Completion: Jun 30, 2019
Last update: Jul 27, 2026

Study contacts

Jun Guo, MD, PhD

principal investigator · Peking University Cancer Hospital & Institute

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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