Apatinib Plus SHR1210 in Advanced Mucosal Melanoma

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03986515
• Other study ID #: HenanCH immunotherapy003
• Status: Recruiting
• Phase: Phase 2
• Start date: June 4, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2019
• Source: Henan Cancer Hospital
• Contact: Lingdi Zhao, Dr.
• Phone: +86-371-65587483
• Email: lingdizhao[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Apatinib
• Melanoma
• Mucosal Melanoma
• SHR-1210

Intervention

Drug:
• apatinib plus SHR-1210
apatinib 250mg qd, 3-5 days later SHR-1210 200mg q3w

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate	the proportion of patients with CR, PR, and SD in the group	three months
Secondary	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
Secondary	overall survival	the time frame from the first day of apatinib to the date of death	eighteen months