Apatinib Plus SHR1210 in Advanced Mucosal Melanoma

Henan Cancer Hospital

Status and phase: Unknown; Phase 2

Conditions: Advanced Cancer; Mucosal Melanoma; SHR-1210; Apatinib

Treatments: Drug: apatinib plus SHR-1210

Study type: Interventional

Funder types: Other

Identifiers

NCT03986515

HenanCH immunotherapy003

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

treatment group

Experimental group

Description:

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

Treatment:

Drug: apatinib plus SHR-1210