Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma

Study Overview
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Brief Summary
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It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.

Official Title
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Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial

Conditions
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Acral Melanoma

Intervention / Treatment
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* Drug: camrelizumab+apatinib+TMZ
* Drug: camrelizumab+apatinib
* Drug: camrelizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age:≥18 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 drug 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; Received a live vaccine within 4 weeks before 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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Three-drug arm<br> | Drug: camrelizumab+apatinib+TMZ<br>* camrelizumab 200mg，q2w+apatinib 250mg，qd+TMZ 200mg/m2，day1-5/28<br>|
| Active Comparator: Two-drug arm<br> | Drug: camrelizumab+apatinib<br>* camrelizumab 200mg，q2w+apatinib 250mg qd<br>|
| Active Comparator: single-drug arm<br> | Drug: camrelizumab<br>* camrelizumab 200mg，q2w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival, PFS | PFS was defined as the time from randomization to progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. | Within 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival ,OS | OS will be defined as the time from randomization to death due to any cause. | Within 2 years | 
| ORR | The objective response rate will be assessed by RECIST 1.1 | Within 2 years | 
| DCR | The disease control rate will be assessed by RECIST 1.1 | Within 2 years | 
| Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. | Within 2 years |