Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can an immune checkpoint blocker outperform interferon in keeping mucosal melanoma at bay?

NCT ID NCT03178123

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This phase II trial tests whether toripalimab, an anti-PD-1 antibody, can prevent mucosal melanoma from returning after surgical removal better than high-dose interferon. Adults aged 18 to 75 whose melanoma was completely removed and who have not had prior adjuvant therapy are eligible. The study compares recurrence-free survival between the two treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an anti-PD-1 immune checkpoint inhibitor called toripalimab, compared with high-dose interferon alfa-2b
What this could lead to
If toripalimab works better than interferon, it could offer a more effective way to prevent mucosal melanoma from coming back after surgery.
What could go wrong
This is a small, early-phase trial with only 6 participants, so results may not apply broadly. Immune checkpoint inhibitors can cause serious immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

6 people

The number who actually took part.

Started

May 2017

Finished

Jun 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Mucosal melanoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.