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Apatinib Plus SHR1210 in Advanced Mucosal Melanoma

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ClinicalTrials.gov Identifier: NCT03986515
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Henan Cancer Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986515


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

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Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03986515     History of Changes
Other Study ID Numbers: HenanCH immunotherapy003
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action