Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma
Recruiting · NCT05789043 · Interventional (participants receive a specific treatment) · Lead sponsor: Peking University Cancer Hospital & Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Beijing Cancer Hospital - Beijing, China