Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Three-drug arm
|
Drug: camrelizumab+apatinib+TMZ
camrelizumab 200mg，q2w+apatinib 250mg，qd+TMZ 200mg/m2，day1-5/28
|
| Active Comparator: Two-drug arm
|
Drug: camrelizumab+apatinib
camrelizumab 200mg，q2w+apatinib 250mg qd
|
| Active Comparator: single-drug arm
|
Drug: camrelizumab
camrelizumab 200mg，q2w
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival, PFS [Within 2 years]
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.
Secondary Outcome Measures
- Overall Survival ,OS [Within 2 years]
OS will be defined as the time from randomization to death due to any cause.
- ORR [Within 2 years]
The objective response rate will be assessed by RECIST 1.1
- DCR [Within 2 years]
The disease control rate will be assessed by RECIST 1.1
- Adverse Events (AEs) [Within 2 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age:≥18 years, male or female.
-
Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
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Has not received any systematic anti-tumor drug treatment.
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Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
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ECOG 0-1.
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Adequate organ function.
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Life expectancy of greater than 12 weeks.
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Patient has given written informed consent.
Exclusion Criteria:
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Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
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Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation.
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Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
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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;
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Received a live vaccine within 4 weeks before the first dose of study medication.
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Pregnancy or breast feeding.
-
Decision of unsuitableness by principal investigator or physician-in charge.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking University Cancer Hospital & Institute
Investigators
- Principal Investigator: Jun Guo, Dr, Peking University Cancer Hospital & Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MA-MM-III-004