Pembrolizumab + Clostridium Novyi-NT for Cancer

Palo Alto (17 mi)

Overseen bySarina Piha-Paul, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

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.

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

I've had at least one cancer treatment when cure wasn't an option.

My advanced cancer can be seen or felt, or identified with imaging.

My cancer has a visible tumor larger than 1 cm but smaller than 12 cm.

I am fully active or restricted in physically strenuous activity but can do light work.

I am 18 years old or older.

I understand the study and can agree to participate.

I can stay within 45 minutes of an ER for 28 days after my treatment.

My cancer has not spread to the bones at the target lesion site.

My organ functions are within normal ranges.

My heart valves are healthy.

Exclusion Criteria

I need to take medication that weakens my immune system.

I have had my spleen removed.

I have had lung inflammation treated with steroids or have it now.

I am currently on medication for an infection.

I have a history of HIV, Hepatitis B, or Hepatitis C.

I have not received a live vaccine in the last 30 days.

I have a confirmed brain tumor or cancer that has spread to my brain.

I have fluid buildup around my lungs or heart that affects my health.

I haven't taken steroids or other immune-weakening medicines in the last week.

Treatment Details

Researchers are testing the highest dose of Clostridium novyi-NT bacteria that's safe with pembrolizumab in patients with advanced tumors. They want to see if this combo helps control the disease better than current treatments.

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab + Clostridium novyi-NTExperimental Treatment3 Interventions

Participants receive Pembrolizumab by vein over about 30 minutes on Day 0 and then every 3 weeks for up to 12 months. Clostridium novyi-NT injected into the tumor on Day 8. Starting on Day 15, participant takes Doxycycline by mouth 2 times a day for the rest of participant's life to lower the risk of further growth of Clostridium novyi-NT