PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma
Primary Purpose
Melanoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR1210
apatinib mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility Criteria
Inclusion Criteria:
- age:18-75 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 SHR- 1210 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;
- Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
- 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
- Guo JunRecruiting
- Beijing Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental arm
Arm Description
SHR1210 plus apatinib
Outcomes
Primary Outcome Measures
ORR
Objective Response Rate
Secondary Outcome Measures
Full Information
NCT ID
NCT03955354
First Posted
May 12, 2019
Last Updated
May 16, 2019
Sponsor
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT03955354
Brief Title
PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma
Official Title
A Phase II Study of PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
April 10, 2020 (Anticipated)
Study Completion Date
April 10, 2021 (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
the investigators launched this exploratory study to evaluate the objective response rate (ORR) of SHR-1210 combined with apatinib mesylate in the first-line treatment of patients with advanced acral melanoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental arm
Arm Type
Experimental
Arm Description
SHR1210 plus apatinib
Intervention Type
Drug
Intervention Name(s)
SHR1210
Intervention Description
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
apatinib mesylate
Intervention Description
apatinib Mesylate is a small molecule tyrosine kinase inhibitor,Through selectively inhibiting the tyrosine kinase activity of the vascular endothelial growth factor receptor 2 (VEGFR-2).
Primary Outcome Measure Information:
Title
ORR
Description
Objective Response Rate
Time Frame
Time Frame: Through study completion, an average of 1 year
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 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 SHR- 1210 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;
Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
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.
Facility Information:
Facility Name
Guo Jun
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Guo, MD
Phone
010-88121122
Ext
01088121122
Email
guoj307@126.com
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Guo
Phone
010-88121122
Ext
01088121122
Email
guoj307@126.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
34858178
Citation
Tian H, Wang X, Lian B, Yan X, Si L, Chi Z, Sheng X, Kong Y, Mao L, Bai X, Tang B, Li S, Zhou L, Cui C, Guo J. Safety Profile of Immunotherapy Combined With Antiangiogenic Therapy in Patients With Melanoma: Analysis of Three Clinical Studies. Front Pharmacol. 2021 Nov 9;12:747416. doi: 10.3389/fphar.2021.747416. eCollection 2021.
Results Reference
derived
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PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma
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