A Study of Toripalimab or Combining With Temozolomide iv in the Treatment of Advanced/Metastatic Malignant Melanoma

  • STATUS
    Recruiting
  • End date
    Sep 7, 2024
  • participants needed
    90
  • sponsor
    First Affiliated Hospital of Zhejiang University
Updated on 24 May 2021
systemic therapy
BRAF
temozolomide
braf v600e mutation

Summary

This study evaluate toripalimab or combining with temozolomide for injection in the treatment of advanced/metastatic malignant melanoma. Participants in arm A receive toripalimab, in arm B receive toripalimab plus temozolomide

Details
Condition Melanoma, Metastatic Melanoma, Malignant Melanoma, melanoma
Treatment Toripalimab, Temozolomide Injection
Clinical Study IdentifierNCT04884997
SponsorFirst Affiliated Hospital of Zhejiang University
Last Modified on24 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Confirmed pathologic or cytologic diagnosis of advanced/metastatic malignant melanomawithout BRAF V600E mutation
ECOG PS 0-1
Age :18 ~75 years old
There were measurable lesions according to RECIST 1.1 and the lesions that had been irradiated showed definite progression after radiotherapy and the lesion was considered measurable only if it was not the only lesion
Proper function of the cardiovascular system, liver, kidney and bone marrow
Subject with at most one systemic therapy for advanced/metastatic malignant melanoma
Survival is expected to exceed 3 months
The subjects showing good compliance voluntarily participated in the study and signed the informed consent

Exclusion Criteria

Previously treated with TMZ, PD-1, or PD-L1
Complicated with other malignant tumors
Subjects with central nervous system metastases and/or cancerous meningitis;(Unless the subjects are asymptomatic or have been treated , no radiographic evidence of new BMs or BMs enlargement is found at least 2 weeks after BMs treatment.If the subjects have active or new untreated asymptomatic central nervous system (CNS) metastases found on imaging during the screening phase,they must receive radiotherapy
Uncontrolled pleural effusion ,pericardial effusion or ascites requiring repeated drainage
Received major surgical treatment or significant traumatic injury within Random 28 days prior
Severe arterial/venous thrombosis eventsSuch as cerebrovascular accident (including temporary ischemic attack) ,deep vein thrombosis and pulmonary embolismwithin Random 6 months prior
Subjects with a history of psychotropic substance abuse and being unable to get rid of it or with mental disorders
Subjects with any severe and/or uncontrolled disease,including
Subjects with poor blood pressure control (systolic 150 mmHg or diastolic 100mmHg)
Subjects with myocardial ischemia or myocardial infarction or arrhythmia above grade I (including male QTC 450ms(male) and female QTC 470ms) And grade 2 congestive heart failure (New York Heart Association (NYHA))
Active or uncontrolled severe infection (CTC AE grade 2 infection)
liver cirrhosis,active hepatitis;active hepatitis(Hepatitis B reference: HBsAg positive, and HBV DNA test value exceeds the normal valueHepatitis C reference: HCV antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value
HIV infected
Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L)
urine protein++,andConfirmated 24-hour urinary protein quantification>1.0 g
Subjects received a preventive vaccineor attenuated vaccine within 4 weeks
prior to first administration
Participated in other clinical trials within 4 weeks
Active autoimmune diseaseSuch as the following, but not limited to: autoimmune hepatitis interstitial pneumonia enteritis vasculitis, nephritisSubjects with asthma requiring bronchodilators for medical intervention were not included requiring systemic treatmentSuch as the use of palliative drugs, corticosteroids, or immunosuppressants occurred within 2 years prior to initial administration.Alternative therapy(Examples include thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy
Other conditions that investigators consider the patients are not suitable
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