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NCT03435952 · ClinicalTrials.gov registry record · Phase 1
Pembrolizumab With Intratumoral Injection of Clostridium Novyi-NT
A Phase 1 study of Malignant Neoplasm of Breast and Malignant Neoplasms of Female Genital Organs, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT03435952: Active Phase 1 study of Malignant Neoplasm of Breast and Malignant Neoplasms of Female Genital Organs, sponsored by M.D. Anderson Cancer Center.
NCT03435952 is a Phase 1 study of Malignant Neoplasm of Breast and Malignant Neoplasms of Female Genital Organs that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 18 participants, below the 60-participant average among 10 other Malignant Neoplasm of Breast trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03435952, a Phase 1 study of Malignant Neoplasm of Breast and Malignant Neoplasms of Female Genital Organs, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
MTD defined as the highest dose studied in which the incidence of DLT was less than 33%.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Doxycycline
- BIOLOGICAL Clostridium Novyi-NT
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-07-10 |
| Est. Completion | 2026-10-01 |
| Phase | Phase 1 |
What the registry record for NCT03435952 still lists
NCT03435952 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 10 other Malignant Neoplasm of Breast trials with a reported enrollment target (70% lower).
The record links to 10 conditions, with Malignant Neoplasm of Breast appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03435952 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03435952 about?
NCT03435952 is a clinical study titled "Pembrolizumab With Intratumoral Injection of Clostridium Novyi-NT". 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 kind...
What is the current status of trial NCT03435952?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2018-07-10. Estimated completion is 2026-10-01.
What conditions does trial NCT03435952 study?
This clinical trial studies the following conditions: Malignant Neoplasm of Breast, Malignant Neoplasms of Female Genital Organs, Malignant Neoplasms of Independent (Primary) Multiple Sites, Malignant Neoplasms of Lip Oral Cavity and Pharynx, Malignant Neoplasms of Male Genital Organs.
What interventions are being tested in trial NCT03435952?
The interventions under investigation include: Pembrolizumab (DRUG), Doxycycline (DRUG), Clostridium Novyi-NT (BIOLOGICAL).
Who is sponsoring clinical trial NCT03435952?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03435952 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03435952's enrollment target sits among peer trials
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