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Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma

Primary Purpose

Acral Melanoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
camrelizumab+apatinib+TMZ
camrelizumab+apatinib
camrelizumab
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acral Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Three-drug arm

Two-drug arm

single-drug arm

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival, PFS
PFS was defined as the time from randomization to progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Overall Survival ,OS
OS will be defined as the time from randomization to death due to any cause.
ORR
The objective response rate will be assessed by RECIST 1.1
DCR
The disease control rate will be assessed by RECIST 1.1
Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment.

Full Information

First Posted
March 16, 2023
Last Updated
September 4, 2023
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05789043
Brief Title
Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma
Official Title
Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
August 15, 2026 (Anticipated)
Study Completion Date
February 15, 2027 (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

5. Study Description

Brief Summary
It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acral Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Three-drug arm
Arm Type
Experimental
Arm Title
Two-drug arm
Arm Type
Active Comparator
Arm Title
single-drug arm
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
camrelizumab+apatinib+TMZ
Intervention Description
camrelizumab 200mg,q2w+apatinib 250mg,qd+TMZ 200mg/m2,day1-5/28
Intervention Type
Drug
Intervention Name(s)
camrelizumab+apatinib
Intervention Description
camrelizumab 200mg,q2w+apatinib 250mg qd
Intervention Type
Drug
Intervention Name(s)
camrelizumab
Intervention Description
camrelizumab 200mg,q2w
Primary Outcome Measure Information:
Title
Progression Free Survival, PFS
Description
PFS was defined as the time from randomization to progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first.
Time Frame
Within 2 years
Secondary Outcome Measure Information:
Title
Overall Survival ,OS
Description
OS will be defined as the time from randomization to death due to any cause.
Time Frame
Within 2 years
Title
ORR
Description
The objective response rate will be assessed by RECIST 1.1
Time Frame
Within 2 years
Title
DCR
Description
The disease control rate will be assessed by RECIST 1.1
Time Frame
Within 2 years
Title
Adverse Events (AEs)
Description
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment.
Time Frame
Within 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Guo, Dr
Phone
010-88121122
Email
guoj307@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Guo, Dr
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Guo
Email
guoj307@126.com

12. IPD Sharing Statement

Learn more about this trial

Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma

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