Phase III Trial to Evaluate the Efficacy and Safety of JS001 Combined With Axitinib for Advanced Mucosal Melanoma

Phase III Trial to Evaluate the Efficacy and Safety of JS001 Combined With Axitinib for Advanced Mucosal Melanoma

Publication date: May 08, 2019

This is a randomized, controlled, multi-center phase III clinical study to evaluate the efficacy and safety of JS001(Toripalimab Injection) combined with Axitinib as first-line therapy in patients with advanced mucosal melanoma. The target population are treatment-naive patients with histopathologically confirmed, unresectable stage III or stage IV mucosal melanoma. At randomization, the patients will be 1:1 randomized to two groups (73 subjects in each): the test group will receive Toripalimab Injection combined with Axitinib; the control group will receive Toripalimab Injection alone; when disease progression or intolerable toxicity occurs in a group, the treatment will be ended in that group while survival follow-up starts.

Concepts Keywords
Abstinence Uncontrolled hypertension
Acute Coronary Syndrome HBV
Addiction Systemic anti tumor
Adjuvant HIV
Alanine Aminotransferase Tumor
Allergy History active tuberculosis
ALT Absorption investigational product
Aminotransferase Compliance protocol
ANC Metastasis
Antibody Massive hydrothorax
Anticoagulant Cervical carcinoma
Anticoagulants Cerebrovascular accident
APTT Mucosal Melanoma
Arrhythmia HCV
Ascites Acute coronary syndrome
Aspartate Transient ischemic attack
AST Pulmonary interstitial pneumonia
Autoimmune Active opportunistic infection
Autoimmune Disease Oral contraceptives
Barrier Contraception Contraception
Basal Barrier contraception
Beijing Bypass
Bilirubin Blood transfusion
Blood Radiotherapy
Blood Transfusion Organ transplant
Bronchospasm Drug therapy
Carcinoma Surgery
Cardiac Ultrasound Immunotherapy
Cardiovascular Organic compounds
Central Nervous System Chemical compounds
Cerebral Infarction Medicine
Cerebrovascular Accident Cancer
Cervical Carcinoma Melanoma
Chronic Diseases RTT
Conduction Block Axitinib
Contraception Brain metastasis
Contraceptive Radiation therapy
Control Group Magnetic resonance imaging
Corticosteroids Ultrasound
Creatinine Compliance protocol
Creatinine Clearance MRI
Deep Vein Thrombosis
Diabetes
Drug Therapy
ECG
Ejection Fraction
Endogenous
Erythropoietin
Excipients
Formula
Gastrointestinal
HBsAg
HBV
HCV
Heart Failure
Hematopoietic
Hemoglobin
Hepatitis
Histopathological
Histopathologically
HIV
Hypertension
Hyperthyroidism
Hypothyroidism
Immunosuppressants
Immunosuppressive
Immunotherapy
Infection
Informed Consent
INR
Lactating
Leptomeningeal
Lesion
Liver
LVEF
Malignant
Melanoma
Mental Disorder
Metastases
Metastasis
Metastatic
Monoclonal Antibody
MRI
Myocardial Infarction
Nephritis
Normalized
Nuclear Magnetic Resonance
Opportunistic Infection
Oral Contraceptives
Organ
Percutaneous Coronary Intervention
Phase III
Platelet
Pneumonia
Prednisone
Pregnancy Test
Progressive
Prostate
Protocol
Psychotics
Pulmonary
Pulmonary Embolism
Radiotherapy
Randomization
Recombinant
Serum
Sexual Intercourse
Squamous Carcinoma
Steroid
Symptomatic Treatment
Syndrome
Toxicity
Transient Ischemic Attack
Tuberculosis
Tumor
Unstable Angina
Urine
Vaccine
VEGFR
Vivo

Semantics

Type Source Name
disease MESH multi
disease DOID Mucosal Melanoma
drug DRUGBANK Axitinib
disease MESH tumor
gene UNIPROT ALG3
gene UNIPROT NR4A2
disease MESH disease progression
drug DRUGBANK Creatinine
disease MESH metastasis
drug DRUGBANK L-Alanine
gene UNIPROT SLC17A5
gene UNIPROT NAAA
gene UNIPROT CD274
disease MESH ECG
disease MESH ventricular ejection fraction
disease MESH men
gene UNIPROT ELL
pathway BSID Reproduction
gene UNIPROT RPL17
gene UNIPROT PDCD1
gene UNIPROT PDCD1LG2
gene UNIPROT KDR
disease MESH basal cell carcinoma
disease DOID basal cell carcinoma
pathway BSID Basal cell carcinoma
disease DOID skin squamous cell carcinoma
disease MESH prostate cancer
disease DOID prostate cancer
pathway BSID Prostate cancer
disease MESH carcinoma in situ
drug DRUGBANK Filgrastim
drug DRUGBANK Erythropoietin
disease MESH hepatitis B
disease DOID hepatitis B
pathway BSID Hepatitis B
drug DRUGBANK Hepatitis B Vaccine (Recombinant)
disease MESH allergy
disease DOID allergy
disease MESH hypertension
disease DOID hypertension
disease MESH hydrothorax
disease MESH ascites
gene UNIPROT CYREN
drug DRUGBANK Prednisone
disease MESH tuberculosis
disease DOID tuberculosis
pathway BSID Tuberculosis
disease MESH Suffering
disease MESH autoimmune disease
disease DOID autoimmune disease
disease MESH syndrome
disease DOID syndrome
disease MESH hypophysitis
disease MESH pneumonia
disease DOID pneumonia
disease MESH hepatitis
disease DOID hepatitis
disease MESH nephritis
disease DOID nephritis
disease MESH hyperthyroidism
disease DOID hyperthyroidism
disease MESH hypothyroidism
disease DOID hypothyroidism
disease MESH deep vein thrombosis
disease MESH pulmonary embolism
disease DOID pulmonary embolism
disease MESH acute coronary syndrome
disease MESH cerebrovascular accident
disease DOID cerebrovascular accident
disease MESH transient ischemic attack
disease DOID transient ischemic attack
disease MESH opportunistic infection
disease MESH infection
disease MESH cardiovascular disease
disease MESH heart failure
pathway BSID Cardiac conduction
disease MESH myocardial infarction
disease DOID myocardial infarction
disease MESH arrhythmia
disease MESH unstable angina pectoris
gene UNIPROT EHD1
disease MESH cerebral infarction
disease DOID cerebral infarction
disease MESH pulmonary disease
disease MESH interstitial pneumonia
disease MESH obstructive pulmonary disease
disease MESH bronchospasm
disease DOID bronchospasm
disease MESH mental disorder
disease MESH abnormalities
disease MESH Melanoma
disease DOID Melanoma
pathway BSID Melanoma
disease DOID Cancer

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