Clinical trial NCT03986515: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mucosal Melanoma
Advanced Cancer
Apatinib
SHR-1210
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2019-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: objective response rate
timeFrame: three months
Secondary outcomes:
measure: progression-free survival
timeFrame: six months
measure: overall survival
timeFrame: eighteen months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Jing Ding, Master
role: PRINCIPAL_INVESTIGATOR
References: