Mucosal MelanomaPhase 2NCT03178123
The Study of JS001 Compared to High-Dose Interferon In Patients With Mucosal Melanoma That Has Been Removed by Surgery
A Phase 2 study testing humanized anti-PD-1 monoclonal antibody Toripalimab and high-dose recombinant interferon a-2B in people with Mucosal Melanoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mucosal Melanoma
- What is being tested?
- humanized anti-PD-1 monoclonal antibody Toripalimab and high-dose recombinant interferon a-2B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2017to 30 Jun 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Mucosal Melanoma
- Being tested
- humanized anti-PD-1 monoclonal antibody Toripalimab, high-dose recombinant interferon a-2B
- Keywords
- anti-PD-1 monoclonal antibody, Mucosal Melanoma, Interferons
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
humanized anti-PD-1 monoclonal antibody ToripalimabBiological
Also called JS001, TAB001
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.
high-dose recombinant interferon a-2BBiological
Also called Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-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.
| Study group | Role | What they receive |
|---|---|---|
| humanized anti-PD-1monoclonal antibody | Experimental | 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) Receives: Biological: humanized anti-PD-1 monoclonal antibody Toripalimab |
| high-dose recombinant interferon a-2B | Active comparator | 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. Receives: Biological: high-dose recombinant interferon a-2B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival rate
to evaluate the Recurrence free survival (RFS) of the patients with mucosal melanoma treated by JS001 and high-Dose interferon
Measured: 5 years
Secondary outcomes (4)
Distant metastases-free survival
to evaluate the distant metastases-free survival of the patients with mucosal melanoma treated by JS001 and high-Dose interferon
Measured: 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
Measured: 3 years
Overall survival (OS)
to evaluate the Overall survival (OS) of the patients with mucosal melanoma treated by JS001 and high-Dose interferon
Measured: 5 years
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start31 May 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Why it stopped: The study strategy was adjusted, and the company decided to terminate the study early
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.
- 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
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Guo, MD, PhD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178123
- Sponsor's protocol ID
- Junshi-JS001-010
- Status last verified
- Jul 2026
- First submitted
- 27 May 2017
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03178123
- Acronym / sponsor ID
- Junshi-JS001-010
- Conditions
- Mucosal Melanoma
- Keywords
- anti-PD-1 monoclonal antibody, Mucosal Melanoma, Interferons
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study strategy was adjusted, and the company decided to terminate the study early
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 6 Jun 2017 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| humanized anti-PD-1monoclonal antibody | Experimental | Biological: humanized anti-PD-1 monoclonal antibody Toripalimabhumanized 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) |
| high-dose recombinant interferon a-2B | Active comparator | Biological: high-dose recombinant interferon a-2BPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
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 |
|---|---|---|
| humanized anti-PD-1 monoclonal antibody ToripalimabAlso: JS001, TAB001humanized 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. | Biological | humanized anti-PD-1monoclonal antibody |
| high-dose recombinant interferon a-2BAlso: Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B15*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. | Biological | high-dose recombinant interferon a-2B |
Primary outcome
Recurrence-free survival rate
Time frame: 5 years
to evaluate the Recurrence free survival (RFS) of the patients with mucosal melanoma treated by JS001 and high-Dose interferon
4 secondary outcomes
Distant metastases-free survival
Time frame: 5 years
recurrence - free survival rate at 3 years
Time frame: 3 years
Overall survival (OS)
Time frame: 5 years
Number of participants with treatment-related adverse events
Time frame: 5 years
Results and safety
The study was stopped early (reason given: The study strategy was adjusted, and the company decided to terminate the study early). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Jun Guo, MD, PhD principal investigator
Peking University Cancer Hospital & Institute
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 humanized anti-PD-1 monoclonal antibody Toripalimab and high-dose recombinant interferon a-2B in people with Mucosal Melanoma, run by Shanghai Junshi Bioscience Co., Ltd. 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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 27 Jul 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?
The study was stopped early (reason given: The study strategy was adjusted, and the company decided to terminate the study early). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival rate (time frame: 5 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 27 Jul 2026.