Combining Camrelizumab, Apatinib, and Temozolomide for Advanced Acral Melanoma Treatment
Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial
This study is testing a new combination of three medications to see if it helps people with advanced acral melanoma live longer without their cancer getting worse compared to standard treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, Camrelizumab, apatinib |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05789043 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combination therapy involving camrelizumab, apatinib, and temozolomide as a first-line treatment for patients with advanced acral melanoma. It is a randomized controlled trial focused on assessing progression-free survival in participants who have not previously received systemic anti-tumor treatment. The study aims to determine if this combination can improve outcomes compared to standard treatments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histopathologically confirmed advanced acral melanoma who have not received prior systemic therapy.
Not a fit: Patients currently undergoing other forms of chemotherapy, radiation, or those with active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve progression-free survival rates for patients with advanced acral melanoma.
How similar studies have performed: While this specific combination has not been widely tested, similar approaches in treating melanoma have shown promising results in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age:≥18 years, male or female. * Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV). * 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. Exclusion Criteria: * Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy. * Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation. * 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 Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; * Received a live vaccine within 4 weeks before the first dose of study medication. * Pregnancy or breast feeding. * Decision of unsuitableness by principal investigator or physician-in charge.
Where this trial is running
Beijing
- Beijing Cancer Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Jun Guo, Dr — Peking University Cancer Hospital & Institute
- Study coordinator: Jun Guo, Dr
- Email: guoj307@126.com
- Phone: 010-88121122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.