Acral Melanoma
Conditions
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.
Interventions
DRUGcamrelizumab+apatinib+TMZ
camrelizumab 200mg，q2w+apatinib 250mg，qd+TMZ 200mg/m2，day1-5/28
DRUGcamrelizumab+apatinib
camrelizumab 200mg，q2w+apatinib 250mg qd
DRUGcamrelizumab
camrelizumab 200mg，q2w
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactJun Guo, Dr
Outcome results
None listed