Clinical trial

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

Name

MA-MM-Ⅱ-003

Description

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

Trial arms

Trial start

2022-09-13

Estimated PCD

2024-12-31

Trial end

2025-12-31

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

Neoadjuvant/adjuvant therapy

Other names:

Apatinib, Temozolomide

Size

Primary endpoint

Pathological response rate

Week 8-12

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2023-07-20

1 organization

1 product

6 indications

Organization

Peking University Cancer Hospital & Institute

Product

Camrelizumab

Indication

Melanoma

Indication