Pembrolizumab With Intratumoral Injection of Clostridium Novyi-NT
Status:
Recruiting
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
Summary
Some tumors are difficult to treat with chemotherapy or radiation. One of the reasons is that
areas of the tumor do not have many blood vessels, which makes it difficult for drugs to
reach those areas. One way that researchers have recently tried to overcome this problem is
by injecting special kinds of bacteria into the tumors. These bacteria have been genetically
changed to remove the chemicals that are poisonous to humans, but are still able to cause
tumor cells to break down and die. The idea is that these bacteria may be able to assist
chemotherapy drugs in fighting cancer.
The goal of this clinical research study is to find the highest tolerable dose of one of
these bacterial therapies (Clostridium novyi-NT spores) that can be given in combination with
pembrolizumab to patients with advanced solid tumors. The safety of this drug will also be
studied, as well as whether it can help to control the disease.
This is an investigational study. Clostridium novyi-NT is not FDA approved or commercially
available. It is currently being used for research purposes only. Pembrolizumab is FDA
approved for the treatment of melanoma and different types of head and neck and non-small
cell lung cancers. It is investigational to use these drugs in combination with each other in
various types of advanced cancers.
The study doctor can describe how the study drugs are designed to work.
Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.
Phase:
Phase 1
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
BioMed Valley Discoveries, Inc Merck Sharp & Dohme Corp.