Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma

Recruiting now · Phase 2

Conditions studied: Melanoma, Acral Melanoma, Temozolomide, Apatinib, Camrelizumab, Neoadjuvant, Pathological Response

In brief

Neoadjuvant therapy is feasible in stage Ⅱ-Ⅲ melanoma, Carrelizumab combined with apatinib and temozolomide has synergistic antitumor effects and may improve pathological response.

Key facts

Study ID

NCT05512481

Run by

Peking University Cancer Hospital & Institute

People needed

60

Starts

2022-09-13

Expected to finish

2026-12-31

Last updated by the study team

2025-03-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age:18-75 years, male or female.
• Histopathologically confirmed acral melanoma (stage Ⅱ/Ⅲ).
• 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 any component of apatinib, temozolomide, Camrelizumab.
• 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
• Patients with any unstable systemic disease, including but not limited to: serious infection, uncontrolled diabetes, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, myocardial infarction, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease;
• Received a live vaccine within 4 weeks of 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, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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