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Trial Title:
Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma
NCT ID:
NCT05789043
Condition:
Acral Melanoma
Conditions: Official terms:
Melanoma
Apatinib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
camrelizumab+apatinib+TMZ
Description:
camrelizumab 200mg，q2w+apatinib 250mg，qd+TMZ 200mg/m2，day1-5/28
Arm group label:
Three-drug arm
Intervention type:
Drug
Intervention name:
camrelizumab+apatinib
Description:
camrelizumab 200mg，q2w+apatinib 250mg qd
Arm group label:
Two-drug arm
Intervention type:
Drug
Intervention name:
camrelizumab
Description:
camrelizumab 200mg，q2w
Arm group label:
single-drug arm
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Guo
Email:
guoj307@126.com
Start date:
March 21, 2023
Completion date:
February 15, 2027
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789043
