Apatinib Plus SHR1210 in Advanced Mucosal Melanoma

Clinical Study of SHR-1210 Plus Apatinib in Patients With Advanced Mucosal Melanoma Whose Diseases Progress After Chemotherapy

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.

Study Overview

• Status: Unknown
• Conditions: Advanced Cancer; Mucosal Melanoma; Apatinib; SHR-1210
• Intervention / Treatment: Drug: apatinib plus SHR-1210

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: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yonghao Yang, Master; Phone Number: +86-371-65587483; Email: 215582454@qq.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Cancer Hospital

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate	the proportion of patients with CR, PR, and SD in the group	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	six months
overall survival	the time frame from the first day of apatinib to the date of death	eighteen months

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 4, 2019
• Primary Completion (ANTICIPATED): May 31, 2021
• Study Completion (ANTICIPATED): May 31, 2022

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (ACTUAL): June 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: HenanCH immunotherapy003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No