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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib + TQB2450 | Experimental | TQB2450 1200 mg IV on Day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycles (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | a multi-target receptor tyrosine kinase inhibitor. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | Maximum tolerated dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of Anlotinib and TQB2450 in advanced acral malignant melanoma patients, Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-21). | up to 21 days |
| Maximum tolerated dose (MTD) | MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT) | up to 21 days |
| Recommended Phase II dose (RP2D) | The RP2D defined as the lower dose level to MTD based on the safety profile | up to 24 months |
| Overall response rate (ORR) | Percentage of subjects achieving complete response (CR) and partial response (PR) | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate(DCR) | Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD) | up to 24 months |
| Progression-free survival (PFS) | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause |
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Inclusion Criteria:
1.18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
2. 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.
5. Has received at least first-line treatment but appeared disease progression or intolerance.
6. The main organs function are normally, the following criteria are met:
8.Understood and signed an informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Guo, Doctor | Contact | 010-88196341 | guoj307@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijin | Beijing Municipality | 100083 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37625814 | Derived | Du Y, Dai J, Mao L, Wei X, Bai X, Chen L, Lin J, Chi Z, Cui C, Sheng X, Lian B, Tang B, Wang X, Yan X, Li S, Zhou L, Guo J, Chen Y, Si L. Phase Ib study of anlotinib in combination with anti-PD-L1 antibody (TQB2450) in patients with advanced acral melanoma. J Eur Acad Dermatol Venereol. 2024 Jan;38(1):93-101. doi: 10.1111/jdv.19467. Epub 2023 Sep 4. |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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| TQB2450 |
| Drug |
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. |
|
| up to 24 months |
| Overall survival (OS) | OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive | up to 24 months |
| Adverse Event | Number of participants with adverse events | up to 24 months |