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

Phase 2

Recruiting

• Conditions: Melanoma; Acral Melanoma; Apatinib; Pathological Response; Temozolomide; Camrelizumab; Neoadjuvant
• Interventions: Drug: Camrelizumab

• Registration Number: NCT05512481
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

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

Detailed Description

Patients with resectable melanoma can benefit from neoadjuvant therapy, including improved surgical outcomes, precise management of patients based on neoadjuvant response, and analysis of resistance mechanisms through histological sections for subsequent treatment. At present, there have been a number of clinical trials exploring the effect of neoadjuvant regimens for melanoma, and some published results have shown that neoadjuvant therapy can lead to a higher pathological response rate, thereby improving the RFS of patients.

In the past, this site has carried out a clinical study of Camrelizumab combined with Apatinib and Temozolomide for first-line treatment of unresectable acral melanoma, with a high preliminary clinical response rate and safety. Based on this, this study intends to evaluate the neoadjuvant treatment of completely resectable melanoma with Camrelizumab combined with Apatinib and Temozolomide in patients with stage III and IIB, IIC high-risk melanoma. To comprehensively evaluate the short-term and long-term benefits of neoadjuvant therapy and provide an important reference for neoadjuvant treatment strategies in the acral melanoma population.

Study Timeline

• Study First Submitted: 2022-08-21
• Study First Submitted QC: 2022-08-21
• Study First Posted: 2022-08-23
• Study Start: 2022-09-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. age:18-75 years, male or female.
2. Histopathologically confirmed acral melanoma (stage Ⅱ/Ⅲ).
3. Has not received any systematic anti-tumor drug treatment.
4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
5. ECOG 0-1.
6. Adequate organ function.
7. Life expectancy of greater than 12 weeks.
8. Patient has given written informed consent.

Exclusion Criteria

1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
2. Known history of hypersensitivity to any component of apatinib, temozolomide, Camrelizumab.
3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
4. Subjects with any active autoimmune disease or history of autoimmune disease
5. 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;
6. Received a live vaccine within 4 weeks of the first dose of study medication.
7. Pregnancy or breast feeding.
8. Decision of unsuitableness by principal investigator or physician-in charge.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant/adjuvant therapy	Camrelizumab	Drug: Camrelizumab Drug: Apatinib mesylate Drug: Temozolomide Injection

Primary Outcome Measures

Name	Time	Method
Pathological response rate	Week 8-12	The primary endpoint is the pathological response rate at surgery after neoadjuvant study treatment.; The pathological response is categorised thus: Complete pathological response (pCR) - 0% viable tumour cells in the surgical specimen Near complete pathological response - (near pCR) - \<10% viable tumour Partial pathological response (pPR) - 10%-50% viable tumour No pathological response (pNR) - \>50% viable tumour

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	Months 0-6	Disease Response as assessed by RECIST 1.1 and mRECIST
Recurrence-free survival	1year,2year	The proportion of patients with an histologically confirmed diagnosis of disease recurrence (local, regional, and distant), as detected by the patient, on physical examination or during imaging surveillance, or death from any cause.
Overall survival	10 years	The proportion of participants deceased from any cause.
Patient reported quality of life	90 days from last dose of study treatment	The individual, summary and composite scores obtained from the validated EUROQOL QLQ-C30 questionnaires.
Safety and tolerability of neoadjuvant and adjuvant treatment and surgical procedures.	90 days from last dose of study treatment	The proportion of patients with adverse events as described in CTCAE version 5.0

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China