Maintenance Treatment of Toripalimab(JS001) in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma

  • STATUS
    Recruiting
  • participants needed
    31
  • sponsor
    Fudan University
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Updated on 19 February 2024
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maintenance treatment
toripalimab
mucosal melanoma
oral contraceptives
melanoma

Summary

This study is a multicenter, single-arm, open, phase clinical study to evaluate the safety and efficacy of Toripalimab(JS001) monoclonal injection after chemotherapy in combination with Endostar for Locally Advanced or Metastatic Mucosal Melanoma.

Details
Condition Mucosal Melanoma
Age 18years - 75years
Treatment Toripalimab, chemotherapy in combination with Endostar
Clinical Study IdentifierNCT04472806
SponsorFudan University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 18-75 years, male or female
Histopathologically confirmed and diagnosed as mucosal melanoma
ECOG score 0 or 1
Life expectancy of at least 12 weeks
SD/PR/CR after chemotherapy in combination with Endostar
No contraindications, having adequate organ and marrow function
Use of highly-effective contraceptive methods during the whole study for men of reproduction ability or women of childbearing potential (e.g. oral contraceptives, intrauterine contraceptive device, abstinence of sexual intercourse or barrier contraception in combination with spermatocide), and continuation of contraception for 12 months after the end of treatment
The subject is voluntary to participate in the study, sign the informed consent form, with good compliance and willingness to cooperate with follow-up

Exclusion Criteria

Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2
Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drug and its components
Skin melanoma, eye melanoma, melanoma with unknown primary foci
Symptomatic brain or meningeal metastases, unless the patient has been treated for > 6 months, the imaging results are negative within 4 weeks before entering the study, and the clinical symptoms associated with the tumor are stable at the time of entering the study
Female patients who are pregnant or lactating, or of childbearing potential but not using appropriate contraceptive measures
Currently having serious and uncontrolled acute infection; or suppurative infection and chronic infection with prolonged wound healing
Having serious heart disorder, including cardiac failure congestive, uncontrollable high-risk arrhythmia, unstable angina pectoris, infarct myocardial, severe cardiac valve disease and refractory hypertension
Having neurological, mental disease or mental disorder that can not be easily controlled, poor compliance, inability to cooperate and narrate therapeutic response
Patients with other malignant tumors at the same time
Patients participated in other clinical trials at the same time
Positive HIV; positive HCV; positive HBsAg or HBcAb whilst positive HBV DNA copies detected (limit of quantitation 500 IU/mL)
Active autoimmune diseases requiring systemic treatment in the past two years (e.g., use of disease-regulating drug, corticosteroid or immunosuppressant), relevant replacement therapy is allowed (e.g., thyroxine, insulin or physiological corticosteroid replacement therapy for renal or pituitary insufficiency)
Having received live vaccine within 4 weeks prior to the start of treatment
Other severe, acute or chronic medical diseases or mental diseases or abnormalities in laboratory examination possibly increasing the relevant risk in study participation or possibly interfering the interpretation of study results as judged by the investigators
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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