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

NCT05512481 | Recruiting Phase 2

• 1 other identifier: MA-MM-Ⅱ-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Acral Melanoma; Temozolomide; Apatinib; Camrelizumab; Neoadjuvant; Pathological Response

Keywords

Acral Melanoma; Immune Checkpoint Inhibitors; Protein Kinase Inhibitors; Antineoplastic Agents, Alkylating

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Objective Response Rate

  Months 0-6

• Recurrence-free survival

  1year,2year

• Overall survival

  10 years

• Safety and tolerability of neoadjuvant and adjuvant treatment and surgical procedures.

  90 days from last dose of study treatment

• Patient reported quality of life

  90 days from last dose of study treatment

Study Arms (1)

Neoadjuvant/adjuvant therapy

EXPERIMENTAL

Drug: Camrelizumab Drug: Apatinib mesylate Drug: Temozolomide Injection

Drug: Camrelizumab

Interventions

Camrelizumab DRUG

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

Also known as: Apatinib, Temozolomide

Neoadjuvant/adjuvant therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

camrelizumab; apatinib; Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jun Guo

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Guo

CONTACT

86-10-88121122; guoj307@126.com

Lili Mao

CONTACT

yunzhongmanbu7848@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 23, 2022
• Study Start: September 13, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)