Tests camrelizumab with apatinib and temozolomide for advanced acral melanoma
Tests camrelizumab, apatinib and temozolomide as first treatment for advanced acral melanoma.
Plain-language title generated from the registry record
Registry title: Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University Cancer Hospital & Institute
- Trial code
- NCT05789043
- Record updated
- 6 September 2023
- Original description
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.Read full original descriptionShow less
Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial
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.
Inclusion: 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: Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy; Received a live vaccine within 4 weeks before the first dose of study medication; 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; Pregnancy or breast feeding; Decision of unsuitableness by principal investigator or physician-in charge.