Pembrolizumab + Clostridium Novyi-NT for Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on systemic corticosteroids or other immunosuppressive medications. You also cannot have had chemotherapy, radiation, or biological cancer therapy within four weeks before starting the trial.
What data supports the effectiveness of the drug pembrolizumab in treating cancer?
Pembrolizumab, a drug that helps the immune system fight cancer, has shown effectiveness in treating various cancers like non-small cell lung cancer and melanoma by blocking a pathway that tumors use to hide from the immune system. It has also shown promise in treating certain types of lymphoma, although more studies are needed.12345
Is the combination of Pembrolizumab and Clostridium Novyi-NT generally safe for humans?
Pembrolizumab has been shown to be safe in human clinical trials, with no significant toxic effects observed in nonhuman primate studies. Clostridium Novyi-NT has been used in early clinical studies and animal models, showing potential as a cancer treatment, but more research is needed to fully understand its safety in humans.46789
What makes the treatment with Pembrolizumab and Clostridium Novyi-NT unique for cancer?
What is the purpose of this trial?
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.
Research Team
Sarina Piha-Paul, MD
Principal Investigator
M.D. Anderson Cancer Center
Sarina Piha-Paul, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with advanced solid tumors who've had at least one systemic cancer therapy, can stay near an ER for 28 days post-treatment, have a caregiver, and meet specific health criteria. Pregnant women or those planning pregnancy are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab by vein every 3 weeks for up to 12 months and a single intratumoral injection of Clostridium novyi-NT on Day 8
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits every 3 months for up to 12 months
Treatment Details
Interventions
- Clostridium Novyi-NT
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
BioMed Valley Discoveries, Inc
Industry Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University