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出境医 / 临床实验 / Apatinib Plus SHR1210 in Advanced Mucosal Melanoma

Apatinib Plus SHR1210 in Advanced Mucosal Melanoma

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.

Condition or disease Intervention/treatment Phase
Mucosal Melanoma Advanced Cancer Apatinib SHR-1210 Drug: apatinib plus SHR-1210 Phase 2

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of SHR-1210 Plus Apatinib in Patients With Advanced Mucosal Melanoma Whose Diseases Progress After Chemotherapy
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: treatment group

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

 Drug: apatinib plus SHR-1210
apatinib 250mg qd, 3-5 days later SHR-1210 200mg q3w
Outcome Measures
Primary Outcome Measures :
  1. objective response rate [ Time Frame: three months ]
    the proportion of patients with CR, PR, and SD in the group


Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: six months ]
    the time frame from the first day of apatinib to the date of confirmed progressive disease or death which one occurrs first.

  2. overall survival [ Time Frame: eighteen months ]
    the time frame from the first day of apatinib to the date of death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Lingdi Zhao, Dr. +86-371-65587483 lingdizhao@126.com
Contact: Yonghao Yang, Master +86-371-65587483 215582454@qq.com

Locations
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China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China
Contact: Lingdi Zhao, Dr.    +86-371-65587483    lingdizhao@126.com   
Sponsors and Collaborators
Henan Cancer Hospital
Investigators
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Principal Investigator: Jing Ding, Master Henan Cancer Hospital
Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date June 14, 2019
Actual Study Start Date  ICMJE June 4, 2019
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019) 		objective response rate [ Time Frame: three months ]
the proportion of patients with CR, PR, and SD in the group
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • progression-free survival [ Time Frame: six months ]
    the time frame from the first day of apatinib to the date of confirmed progressive disease or death which one occurrs first.
  • overall survival [ Time Frame: eighteen months ]
    the time frame from the first day of apatinib to the date of death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Apatinib Plus SHR1210 in Advanced Mucosal Melanoma
Official Title  ICMJE Clinical Study of SHR-1210 Plus Apatinib in Patients With Advanced Mucosal Melanoma Whose Diseases Progress After Chemotherapy
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mucosal Melanoma
  • Advanced Cancer
  • Apatinib
  • SHR-1210
Intervention  ICMJE Drug: apatinib plus SHR-1210
apatinib 250mg qd, 3-5 days later SHR-1210 200mg q3w
Study Arms  ICMJE Experimental: treatment group

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: Drug: apatinib plus SHR-1210
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lingdi Zhao, Dr. +86-371-65587483 lingdizhao@126.com
Contact: Yonghao Yang, Master +86-371-65587483 215582454@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986515
Other Study ID Numbers  ICMJE HenanCH immunotherapy003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Henan Cancer Hospital
Study Sponsor  ICMJE Henan Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jing Ding, Master Henan Cancer Hospital
PRS Account Henan Cancer Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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