Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Acral Malignant Melanoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    42
  • sponsor
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Updated on 23 January 2021

Summary

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

Details
Condition Advanced Acral Malignant Melanoma
Treatment Anlotinib, TQB2450
Clinical Study IdentifierNCT03991975
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Advanced Acral Malignant Melanoma?
Do you have any of these conditions: Do you have Advanced Acral Malignant Melanoma??
18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance
status score of 0 or 1; Life expectancy 3 months
\. Histologically or cytologically confirmed advanced acral malignant
melanoma. 3. At least one measurable lesion. 4. Providing tumor specimen
obtained by biopsy or surgical sample within 2 years
\. Has received at least first-line treatment but appeared disease
progression or intolerance
\. The main organs function are normally, the following criteria are met
hemoglobin 90 g/L; neutrophils 1.510^9/L; platelets 100 x 10^9/ L
total bilirubin 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) 2.5 x ULN ; serum creatinine 1ULNcreatinine clearance >50 umol/L
INR, aPTT, PT1.5 x ULN
left ventricular ejection fraction (LVEF) 50%. 7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization
Understood and signed an informed consent form

Exclusion Criteria

Prior therapy with VEGFR-target TKI included anlotinib or an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components
Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix
Has any active autoimmune disease or history of autoimmune disease
Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration
Has multiple factors affecting oral medication
Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Has any bleeding or bleeding events grade 3 or with unhealed wounds, ulcerative , or fractures within 4 weeks prior to the first administration
Has uncontrollable symptoms of brain metastasis, spinal cord compression, cancerous meningitis during screening within 8 weeks before first dose
Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks
Has any serious and / or uncontrolled disease
Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first dose
Has received granulocyte colony stimulating factor(G -CSF)or Granulocyte macrophage colony stimulating factor (GM-CSF) within 4 weeks prior to first dose
According to the judgement of the researchers, there are other factors that may lead to the termination of the study. For example, other serious diseases including mental disorders need to be treated together, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data and samples
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