Pembrolizumab With Intratumoral Injection of Clostridium Novyi-NT

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.

Conditions

• Malignant Neoplasm of Breast
• Malignant Neoplasms of Digestive Organs
• Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System
• Malignant Neoplasms of Female Genital Organs
• Malignant Neoplasms of Ill-defined Secondary and Unspecified Sites
• Malignant Neoplasms of Independent (Primary) Multiple Sites
• Malignant Neoplasms of Lip Oral Cavity and Pharynx
• Malignant Neoplasms of Male Genital Organs
• Malignant Neoplasms of Mesothelial and Soft Tissue
• Malignant Neoplasms of Respiratory and Intrathoracic Organs
• Malignant Neoplasms of Thyroid and Other Endocrine Glands
• Malignant Neoplasms of Urinary Tract

Interventions

DRUG

Pembrolizumab

200 mg by intravenous infusion starting on Day 0, and continuing every 3 weeks for up to 12 months.

BIOLOGICAL

Clostridium Novyi-NT

Participants given a single dose of Clostridium Novyi-NT by intratumoral injection on Day 8. Clostridium Novyi-NT administered starting with Cohort 1 at a dose of 3 x 10\^4 spores followed by dose escalation.

DRUG

Doxycycline

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

Sponsors & Collaborators

• BioMed Valley Discoveries, Inc

  collaborator INDUSTRY

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Sarina Piha-Paul, MD, PHD · M.D. Anderson Cancer Center

• Sarina Piha-Paul, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-10

Primary Completion

2026-10-01

Completion

2026-10-01

FDA Drug

Yes

Countries

• United States

Study Locations