search
Back to results

Apatinib Plus SHR1210 in Advanced Mucosal Melanoma

Primary Purpose

Mucosal Melanoma, Advanced Cancer, Apatinib

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
apatinib plus SHR-1210
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucosal Melanoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • mucosal melanoma by pathology
  • expected lifespan ≥ 3 months
  • ECOG 0-2
  • failure after one kind of chemotherapeutic regimen
  • at least one measurable lesion by RECIST 1.1
  • enough organ function
  • blood pressure is normal; for patients with hypertension the blood pressure should be controlled in normal by antihypertensive drugs
  • no other serious diseases conflicting with this regimen
  • no history of other malignancies
  • pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
  • informed consent from the patient

Exclusion Criteria:

  • Suffering from serious infectious diseases within 4 weeks before enrollment
  • requiring intermittent use of bronchodilators or medical interventions
  • usage of immunosuppressants before enrollment and the dose of immunosuppressant used ≥ 10mg / day oral prednisone for more than 2 weeks
  • serious allergy
  • serious mental diseases
  • abnormal coagulation funtion,bleeding tendency or receiving thrombolytic or anticoagulant therapy
  • abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks prior to enrollment
  • previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc.
  • other situations evaluated by investigator unsuitable for this study

Sites / Locations

  • Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment group

Arm Description

apatinib 250mg orally once a day until disease progression of occurrence of intolerable adverse events. SHR-1210 200mg every two weeks until disease progression of occurrence of intolerable adverse events. (the first dose of SHR-1210 is set on the 3-5 days after apatinib

Outcomes

Primary Outcome Measures

objective response rate
the proportion of patients with CR, PR, and SD in the group

Secondary Outcome Measures

progression-free survival
the time frame from the first day of apatinib to the date of confirmed progressive disease or death which one occurrs first.
overall survival
the time frame from the first day of apatinib to the date of death

Full Information

First Posted
June 11, 2019
Last Updated
June 11, 2019
Sponsor
Henan Cancer Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03986515
Brief Title
Apatinib Plus SHR1210 in Advanced Mucosal Melanoma
Official Title
Clinical Study of SHR-1210 Plus Apatinib in Patients With Advanced Mucosal Melanoma Whose Diseases Progress After Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Cancer Hospital

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
There is still no effective treatment for advanced mucosal melanoma at present. The efficacy of single-agent PD-1 inhibitors is less than 20%. It is urgent to explore regimens to improve the efficacy of PD-1 inhibitors in patients with advanced mucosal melanoma. This study is performed to explore the safety and efficacy of apatinib plus SHR-1210 in patients with advanced mucosa melanoma whose diseases progress after chemotherapy.
Detailed Description
Apatinib is an oral small molecule anti-angiogenesis inhibitors. It inhibits VEGFR-2 tyrosine kinase activity, thereby blocking VEGF-induced signaling and exerting a strong inhibitory effect on tumor angiogenesis.Apatinib has shown anti-melanoma activity in retrospective study. However, the efficacy is still very low. SHR-1210 is an anti-PD-1 antibody produced by Hengrui Pharmaceutical Co., Ltd. Apatinib plus SHR-1210 has shown synergy in several malignancies. This study is conducted to explore the efficacy and safety in advanced mucosa melanoma

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucosal Melanoma, Advanced Cancer, Apatinib, SHR-1210

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
treatment group
Arm Type
Experimental
Arm Description
apatinib 250mg orally once a day until disease progression of occurrence of intolerable adverse events. SHR-1210 200mg every two weeks until disease progression of occurrence of intolerable adverse events. (the first dose of SHR-1210 is set on the 3-5 days after apatinib
Intervention Type
Drug
Intervention Name(s)
apatinib plus SHR-1210
Intervention Description
apatinib 250mg qd, 3-5 days later SHR-1210 200mg q3w
Primary Outcome Measure Information:
Title
objective response rate
Description
the proportion of patients with CR, PR, and SD in the group
Time Frame
three months
Secondary Outcome Measure Information:
Title
progression-free survival
Description
the time frame from the first day of apatinib to the date of confirmed progressive disease or death which one occurrs first.
Time Frame
six months
Title
overall survival
Description
the time frame from the first day of apatinib to the date of death
Time Frame
eighteen months

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: mucosal melanoma by pathology expected lifespan ≥ 3 months ECOG 0-2 failure after one kind of chemotherapeutic regimen at least one measurable lesion by RECIST 1.1 enough organ function blood pressure is normal; for patients with hypertension the blood pressure should be controlled in normal by antihypertensive drugs no other serious diseases conflicting with this regimen no history of other malignancies pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study informed consent from the patient Exclusion Criteria: Suffering from serious infectious diseases within 4 weeks before enrollment requiring intermittent use of bronchodilators or medical interventions usage of immunosuppressants before enrollment and the dose of immunosuppressant used ≥ 10mg / day oral prednisone for more than 2 weeks serious allergy serious mental diseases abnormal coagulation funtion,bleeding tendency or receiving thrombolytic or anticoagulant therapy abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks prior to enrollment previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc. other situations evaluated by investigator unsuitable for this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lingdi Zhao, Dr.
Phone
+86-371-65587483
Email
lingdizhao@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yonghao Yang, Master
Phone
+86-371-65587483
Email
215582454@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Ding, Master
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingdi Zhao, Dr.
Phone
+86-371-65587483
Email
lingdizhao@126.com

12. IPD Sharing Statement

Learn more about this trial

Apatinib Plus SHR1210 in Advanced Mucosal Melanoma

We'll reach out to this number within 24 hrs