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Trial Title:
Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma
NCT ID:
NCT05512481
Condition:
Melanoma
Acral Melanoma
Temozolomide
Apatinib
Camrelizumab
Neoadjuvant
Pathological Response
Conditions: Official terms:
Melanoma
Temozolomide
Apatinib
Conditions: Keywords:
Acral Melanoma
Immune Checkpoint Inhibitors
Protein Kinase Inhibitors
Antineoplastic Agents, Alkylating
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
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
Arm group label:
Neoadjuvant/adjuvant therapy
Other name:
Apatinib
Other name:
Temozolomide
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.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Guo, Director
Phone:
13911233048
Email:
guoj307@126.com
Start date:
September 13, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05512481