Can an immune checkpoint blocker outperform interferon in keeping mucosal melanoma at bay?
NCT ID NCT03178123
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
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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
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May 2017
- Finished
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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
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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 Hide 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
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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
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