An International Placebo-Controlled Comparative Randomized Trial of Efficacy and Safety of Sequential BCD-217 and BCD-100 Therapy Compared to BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma

An International Placebo-Controlled Comparative Randomized Trial of Efficacy and Safety of Sequential BCD-217 and BCD-100 Therapy Compared to BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma

Publication date: Apr 12, 2019

This is a multicenter randomized double-blind placebo-controlled phase II clinical trial. The purpose of this trial is to evaluate efficacy and safety of therapy consisting of BCD-217 (fixed dose combination of anti-CTLA-4 and anti-PD-1 monoclonal antibodies) and sequential BCD-100 (anti-PD-1 monoclonal antibody) versus BCD-100 monotherapy as first-line treatment in patients with treatment-nacEFve unresectable or metastatic melanoma.

Concepts Keywords
Angina Cancer therapy
Angioedema Systemic autoimmune diseases
Asthma IV stable angina
Atopic Melanoma
BCD Unstable angina
Biopsy Interstitial lung pneumonia
Birth Control Hematologic disorders
Blood Prior anti cancer
BRAF III heart failure
Cancer Severe resistant hypertension
Central Nervous System Unresectable Metastatic Melanoma
Clinical Trial SLE
Colony Stimulating Factors Ocular melanoma
Corticosteroids Intervention pulmonary lymphangitis
Double Blind Severe concomitant diseases
Endocrine Birth control
First Line Investigational therapy
Fixed Dose Combination Radiotherapy
Gastrointestinal Disorder Cancer therapy
Grade III Health
Heart Failure Articles
Hepatic Drug discovery
Histological Clinical research
Histologically Design of experiments
Hypertension Melanoma
Immunosuppressants RTT
Informed Consent Radiation therapy
Investigational Drug Placebo-controlled study
Lesion Clinical trial
Lung Ipilimumab
Melanoma Treating cancer
Metabolism Antibodies
Metastases
Metastatic
Monoclonal Antibodies
Monoclonal Antibody
Monotherapy
Myocardial Infarction
Nave
Neurological
Neutrophils
Pericardial
Peritoneal Effusion
Placebo
Pleural
Pneumonia
Pulmonary
Radiotherapy
Randomization
Renal
Respiratory Failure
Systemic Autoimmune Diseases
Systemic Scleroderma
Ulcerative Colitis
Unstable Angina

Semantics

Type Source Name
gene UNIPROT CYP4V2
disease MESH Melanoma
disease DOID Melanoma
pathway BSID Melanoma
gene UNIPROT CTLA4
gene UNIPROT RPL17
gene UNIPROT PDCD1
gene UNIPROT CD274
gene UNIPROT BRAF
disease MESH cancer
disease DOID cancer
gene UNIPROT PDCD1LG2
disease DOID Ocular melanoma
disease MESH metastases
disease MESH complications
disease MESH lymphangitis
disease DOID lymphangitis
disease MESH stable angina
disease MESH Unstable angina
disease DOID Unstable angina
disease MESH myocardial infarction
disease DOID myocardial infarction
disease MESH heart failure
disease MESH hypertension
disease DOID hypertension
disease DOID atopic asthma
disease MESH angioedema
disease DOID angioedema
disease MESH respiratory failure
disease DOID respiratory failure
disease MESH chronic obstructive pulmonary disease
disease DOID chronic obstructive pulmonary disease
pathway BSID Metabolism
disease MESH renal
disease DOID gastrointestinal disorder
disease MESH autoimmune diseases
disease MESH ulcerative colitis
disease DOID ulcerative colitis
disease MESH systemic scleroderma
disease DOID systemic scleroderma
disease MESH inflammatory myopathy
disease MESH mixed connective tissue disease
disease DOID mixed connective tissue disease
disease MESH overlap syndrome
disease MESH Interstitial lung disease
disease DOID Interstitial lung disease
disease MESH pneumonia
disease DOID pneumonia
gene UNIPROT NR4A2
gene UNIPROT ALG3

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