What is mdx 1106?
BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
What is bms 936558?
An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC (Checkmate 171)
What is objective response rate?
Background: Objective response rate (ORR), defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST), is the most common endpoint used in pivotal trials supporting FDA approval of cancer drugs for solid tumor …
Who discovered Nivolumab?
Through the research collaboration with Ono, it was invented by Dr. Changyu Wang and his team of scientists at Medarex using its transgenic mice with a humanized immune system; the discovery and in vitro characterization of the antibody, originally called MDX-1106/ONO-4538, was published (much later) in 2014.
What is the difference between objective and overall response rate?
Response rate (RR)Response rate measures disease size, usually using a scan or X-ray. Complete response (CR) Disappearance of all clinical evidence of disease. Objective response rate (ORR)Percentage of patients whose disease decreased (Partial response – PR) and/or disappears (Complete response – CR) after treatment.
What cancers is nivolumab used for?
When nivolumab is given alone to treat melanoma, non-small cell lung cancer (NSCLC), Hodgkin lymphoma, head and neck cancer, urothelial cancer, advanced RCC, colorectal cancer, or esophageal cancer, it is usually given once every 2 or 4 weeks depending on your dosage for as long as your doctor recommends that you …
Who manufactures ipilimumab?
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic non-small cell …
Is partial remission good?
Partial remission means the cancer is still there, but your tumor has gotten smaller — or in cancers like leukemia, you have less cancer throughout your body. Some doctors tell patients to think of their cancer as “chronic,” like heart disease. It’s something you will need to continue to check.
Is overall response rate a surrogate endpoint?
There were six surrogate endpoints listed for solid tumors in the table: durable overall response rate (ORR), progression-free survival (PFS), Disease-free survival (DFS), event-free survival (EFS), pathological complete response (pCR) and metastasis-free survival.