Clinical Trials Update from NCI, August 2018

Clinical Trials Update from NCI, August 2018

Clinical Trials
Updates from the National Cancer Institute
Clinical Trials News
		Targeted Drug Approved for Acute Myeloid Leukemia with IDH1 Gene Mutations The Food and Drug Administration (FDA) has approved ivosidenib (Tibsovo) for the treatment of adults with acute myeloid leukemia (AML) that has a specific mutation in a gene called IDH1. Ivosidenib, the first FDA-approved IDH1-targeted treatment, was approved based on results from a phase 1 trial.
New Immunotherapy Option Approved for Cervical Cancer, Rare Lymphoma On the strength of results from two phase 2 trials, FDA has approved pembrolizumab (Keytruda) for some women with advanced cervical cancer and some patients with primary mediastinal large B-cell lymphoma (PMBCL), a rare type of non-Hodgkin lymphoma.
		Combination of Immunotherapy Drugs Approved for Metastatic Colorectal Cancer FDA has approved the combination of the immune checkpoint inhibitors ipilimumab (Yervoy) and nivolumab (Opdivo) for the treatment of patients with metastatic colorectal cancer whose tumor cells have defects that affect their ability to repair DNA. Supporting data for the approval come from a nonrandomized multi-arm phase 2 trial comparing nivolumab alone with nivolumab combined with drugs.
		Find NCI-Supported Clinical Trials Use our search form to find a clinical trial or other research study that may be right for you or a loved one.
Clinical Trials Information for Patients and Caregivers Randomization and Bias in Cancer Clinical Trials In some phase 2 and all phase 3 clinical trials, patients are randomly assigned by chance to groups that receive different treatments. This process is called randomization, and it is intended to ensure that the patients in these different groups are similar. This page presents information about randomization, bias, and blinding in cancer clinical trials. Use of Placebos A placebo is a pill or liquid solution designed to look like the medicine being tested in a trial, but it is not an active medication. This page explains when, how, and why placebos may be used in cancer clinical trials. Research Team Members Participants in clinical trials are cared for by a team of health care providers. This page explains the roles of some of the key members of a clinical trial research team. NCI-Supported Clinical Trials that Are Recruiting Patients Experimental Immunotherapy Drug for Small Cell Lung Cancer This phase 1/2 trial is testing an experimental immunotherapy drug, either alone or combined with one of two approved drugs (topotecan or temozolomide), in patients with recurrent small cell lung cancer. The experimental drug, M7824, is a fusion protein that interferes with two molecular pathways that tumors employ to prevent immune responses against cancer cells. Accelerated Chemotherapy for Patients with Advanced Germ Cell Tumors This randomized phase 3 trial studies how well an accelerated schedule of bleomycin sulfate, etoposide phosphate, and cisplatin (BEP) chemotherapy works compared with the standard schedule of BEP chemotherapy in treating patients with intermediate or poor-risk germ cell tumors that have spread to other places in the body. Doctors want to see if giving BEP chemotherapy on a faster, or “accelerated” schedule will work better and lead to fewer side effects for these patients. Tomosynthesis Mammographic Imaging Screening Trial (TMIST) This randomized phase 3 trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.