Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma

Recruiting now · Phase 3

Conditions studied: Acral Melanoma

In brief

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.

Key facts

Study ID

NCT05789043

Run by

Peking University Cancer Hospital & Institute

People needed

140

Starts

2023-03-21

Expected to finish

2027-02-15

Last updated by the study team

2023-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Beijing Cancer Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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