- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03955354
PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma
May 16, 2019 updated by: Jun Guo, Peking University Cancer Hospital & Institute
A Phase II Study of PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Recruiting
- Beijing Cancer Hospital
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Contact:
- Jun Guo
- Phone Number: 01088121122 010-88121122
- Email: guoj307@126.com
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Beijing
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Beijing, Beijing, China, 100142
- Recruiting
- Guo Jun
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Contact:
- Jun Guo, MD
- Phone Number: 01088121122 010-88121122
- Email: guoj307@126.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental arm
SHR1210 plus apatinib
|
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: Time Frame: Through study completion, an average of 1 year
|
Objective Response Rate
|
Time Frame: Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2019
Primary Completion (Anticipated)
April 10, 2020
Study Completion (Anticipated)
April 10, 2021
Study Registration Dates
First Submitted
May 12, 2019
First Submitted That Met QC Criteria
May 16, 2019
First Posted (Actual)
May 20, 2019
Study Record Updates
Last Update Posted (Actual)
May 20, 2019
Last Update Submitted That Met QC Criteria
May 16, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-1210-APTN-IIT-MM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Viewpoint Molecular TargetingRecruitingMetastatic Melanoma | Melanoma (Skin) | Mucosal Melanoma | Melanoma Stage IV | Melanoma Stage III | Melanoma, UvealUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
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Clinical Trials on SHR1210
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Peking University Cancer Hospital & InstituteRecruiting
-
Henan Cancer HospitalActive, not recruiting
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Yanqiao ZhangJiangsu HengRui Medicine Co., Ltd.UnknownHepatocellular Carcinoma
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Qilu Hospital of Shandong UniversityRecruiting
-
Peking UniversityUnknown
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Hunan Cancer HospitalJiangsu HengRui Medicine Co., Ltd.RecruitingEsophageal Squamous Cell CarcinomaChina
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Henan Cancer HospitalJiangsu HengRui Medicine Co., Ltd.UnknownSmall Cell Lung Cancer Extensive StageChina
-
Wuhan UniversityRecruiting
-
Peking University Cancer Hospital & InstituteUnknown
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Hunan Cancer HospitalSuzhou Sheng Diya Biomedical Co., Ltd.Active, not recruitingAdenocarcinoma of the LungChina