Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma
NCT ID: NCT05789043
Last Updated: 2023-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
140 participants
INTERVENTIONAL
2023-03-21
2027-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Three-drug arm
camrelizumab+apatinib+TMZ
camrelizumab 200mg，q2w+apatinib 250mg，qd+TMZ 200mg/m2，day1-5/28
Two-drug arm
camrelizumab+apatinib
camrelizumab 200mg，q2w+apatinib 250mg qd
single-drug arm
camrelizumab
camrelizumab 200mg，q2w
Interventions
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camrelizumab+apatinib+TMZ
camrelizumab 200mg，q2w+apatinib 250mg，qd+TMZ 200mg/m2，day1-5/28
camrelizumab+apatinib
camrelizumab 200mg，q2w+apatinib 250mg qd
camrelizumab
camrelizumab 200mg，q2w
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Responsible Party
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Jun Guo
Chief physician
Principal Investigators
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Jun Guo, Dr
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MA-MM-III-004
Identifier Type: -
Identifier Source: org_study_id
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