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

A Phase 2 Clinical Trial of Neoadjuvant Camrelizumab Plus Apatinib and Temozolomide in High Risk Clinical Stage Ⅱ-Ⅲ Acral Melanoma

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

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Temozolomide; Apatinib; Camrelizumab; Acral Melanoma; Neoadjuvant; Pathological Response
• Intervention / Treatment: Drug: Camrelizumab

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jun Guo; Phone Number: 86-10-88121122; Email: guoj307@126.com
• Study Contact Backup: Name: Lili Mao; Email: yunzhongmanbu7848@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Jun Guo, Director; Phone Number: 13911233048; Email: guoj307@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neoadjuvant/adjuvant therapy; Drug: Camrelizumab Drug: Apatinib mesylate Drug: Temozolomide Injection	Drug: Camrelizumab; NEOADJUVANT: All participants will receive neoadjuvant therapy with combination of Camrelizumab、Apatinib and Temozolomide for 2 cycle； SURGERY: All participants will have melanoma surgery after 2 cycles of treatment ADJUVANT: Participants will receive Camrelizumab every 3 weeks for 1 year; Other Names: Apatinib; Temozolomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological response rate	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	Week 8-12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The proportion of participants deceased from any cause.	10 years
Objective Response Rate	Disease Response as assessed by RECIST 1.1 and mRECIST	Months 0-6
Recurrence-free survival	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.	1year,2year
Safety and tolerability of neoadjuvant and adjuvant treatment and surgical procedures.	The proportion of patients with adverse events as described in CTCAE version 5.0	90 days from last dose of study treatment
Patient reported quality of life	The individual, summary and composite scores obtained from the validated EUROQOL QLQ-C30 questionnaires.	90 days from last dose of study treatment

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Investigators: Principal Investigator: Jun Guo, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 21, 2022
• First Submitted That Met QC Criteria: August 21, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Immune Checkpoint Inhibitors; Acral Melanoma; Protein Kinase Inhibitors; Antineoplastic Agents, Alkylating
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide; Apatinib
• Other Study ID Numbers: MA-MM-Ⅱ-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No