Back to resultsCamrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma
Primary Purpose
Melanoma, Acral Melanoma, Temozolomide
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Acral Melanoma, Immune Checkpoint Inhibitors, Protein Kinase Inhibitors, Antineoplastic Agents, Alkylating
Eligibility Criteria
Inclusion 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Beijing Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neoadjuvant/adjuvant therapy
Arm Description
Drug: Camrelizumab Drug: Apatinib mesylate Drug: Temozolomide Injection
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Objective Response Rate
Disease Response as assessed by RECIST 1.1 and mRECIST
Recurrence-free survival
The proportion of patients with an histologically confirmed diagnosis of disease recurrence (local, regional, and distant), as detected by the patient, on physical examination or during imaging surveillance, or death from any cause.
Overall survival
The proportion of participants deceased from any cause.
Safety and tolerability of neoadjuvant and adjuvant treatment and surgical procedures.
The proportion of patients with adverse events as described in CTCAE version 5.0
Patient reported quality of life
The individual, summary and composite scores obtained from the validated EUROQOL QLQ-C30 questionnaires.
Full Information
NCT ID
NCT05512481
First Posted
August 21, 2022
Last Updated
July 18, 2023
Sponsor
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT05512481
Brief Title
Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma
Official Title
A Phase 2 Clinical Trial of Neoadjuvant Camrelizumab Plus Apatinib and Temozolomide in High Risk Clinical Stage Ⅱ-Ⅲ Acral Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Acral Melanoma, Temozolomide, Apatinib, Camrelizumab, Neoadjuvant, Pathological Response
Keywords
Acral Melanoma, Immune Checkpoint Inhibitors, Protein Kinase Inhibitors, Antineoplastic Agents, Alkylating
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neoadjuvant/adjuvant therapy
Arm Type
Experimental
Arm Description
Drug: Camrelizumab
Drug: Apatinib mesylate
Drug: Temozolomide Injection
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Other Intervention Name(s)
Apatinib, Temozolomide
Intervention 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
Primary Outcome Measure Information:
Title
Pathological response rate
Description
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
Time Frame
Week 8-12
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
Disease Response as assessed by RECIST 1.1 and mRECIST
Time Frame
Months 0-6
Title
Recurrence-free survival
Description
The proportion of patients with an histologically confirmed diagnosis of disease recurrence (local, regional, and distant), as detected by the patient, on physical examination or during imaging surveillance, or death from any cause.
Time Frame
1year,2year
Title
Overall survival
Description
The proportion of participants deceased from any cause.
Time Frame
10 years
Title
Safety and tolerability of neoadjuvant and adjuvant treatment and surgical procedures.
Description
The proportion of patients with adverse events as described in CTCAE version 5.0
Time Frame
90 days from last dose of study treatment
Title
Patient reported quality of life
Description
The individual, summary and composite scores obtained from the validated EUROQOL QLQ-C30 questionnaires.
Time Frame
90 days from last dose of study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Guo
Phone
86-10-88121122
Email
guoj307@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lili Mao
Email
yunzhongmanbu7848@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Guo
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Guo, Director
Phone
13911233048
Email
guoj307@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma
We'll reach out to this number within 24 hrs