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New treatment option for Melanoma
Official title Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma
ClinicalTrials.gov ID: NCT05512481
What this study is testing
What is Camrelizumab?
Camrelizumab is an investigational medicine, being studied as a potential treatment for melanoma.
Also referred to as Apatinib, Temozolomide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Neoadjuvant therapy is feasible in stage Ⅱ-Ⅲ melanoma, Carrelizumab combined with apatinib and temozolomide has synergistic antitumor effects and may improve pathological response.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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.
You likely can't join 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.
- people before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
- people 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...
- Received a live vaccine within 4 weeks of the first dose of study medication.
See the full eligibility criteria
- 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.
- 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.
- people before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
- people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.