Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma

Study Overview
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Brief Summary
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It is a single-center,exploratory clinical trial aimed to evaluate the objective response rate (ORR) of Camrelizumab combined with apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma.

Official Title
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Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma：a Single-center, Exploratory Clinical Study

Conditions
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Melanoma

Intervention / Treatment
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* Drug: SHR1210
* Drug: apatinib mesylate
* Drug: Temozolomide Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age:18-75 years, male or female. Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV). Has not received any systematic anti-tumor drug treatment. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. ECOG 0-1. Adequate organ function. Life expectancy of greater than 12 weeks. Patient has given written informed consent. Exclusion Criteria: Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ); Subjects with any active autoimmune disease or history of autoimmune disease Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator); Received a live vaccine within 4 weeks of the first dose of study medication. Pregnancy or breast feeding. Decision of unsuitableness by principal investigator or physician-in charge.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Camre+Apa+TMZ<br> | Drug: SHR1210<br>* SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody<br>Drug: apatinib mesylate<br>* apatinib Mesylate is a small molecule tyrosine kinase inhibitor,Through selectively inhibiting the tyrosine kinase activity of the vascular endothelial growth factor receptor 2 (VEGFR-2).<br>Drug: Temozolomide Injection<br>* Temozolomide is an imidazole tetrazine derivative of the alkylating agent dacarbazine.Temozolomide is not directly active but undergoes rapid, spontaneous, non-enzymatic conversion at physiologic pH to the cytotoxic compound, monomethyl triazeno imidazole carboxamide (MTIC).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Response Rate | Through study uncompletion, an average of 1 year |