18 Participants Needed

Pembrolizumab + Clostridium Novyi-NT for Cancer

RK
Overseen ByRabia Khan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

This treatment is unique because it combines Pembrolizumab, an immune checkpoint inhibitor that enhances the body's immune response against cancer cells, with Clostridium Novyi-NT, a bacterium that can selectively target and destroy tumor cells, offering a novel approach to cancer therapy.24101112

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 A. Piha-Paul | MD Anderson ...

Sarina Piha-Paul, MD

Principal Investigator

M.D. Anderson Cancer Center

Sarina A. Piha-Paul | MD Anderson ...

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

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.
See 10 more

Exclusion Criteria

Your oxygen levels are lower than 95% when breathing without extra oxygen.
I need to take medication that weakens my immune system.
I had an organ transplant less than 3 months ago.
See 20 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

12 months
In-person visits every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits every 3 months for up to 12 months

12 months
In-person visits every 3 months

Treatment Details

Interventions

  • Clostridium Novyi-NT
  • Pembrolizumab
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

BioMed Valley Discoveries, Inc

Industry Sponsor

Trials
19
Recruited
650+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Findings from Research

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
Pembrolizumab (Keytruda) effectively blocks the PD-1 pathway, enhancing T-cell activity against tumors, which supports its role in promoting tumor regression and immune rejection.
Preclinical studies in cynomolgus monkeys showed that pembrolizumab has a favorable safety profile with no significant toxicological findings, aligning with its demonstrated safety and efficacy in human clinical trials.
Biophysical and Immunological Characterization and In Vivo Pharmacokinetics and Toxicology in Nonhuman Primates of the Anti-PD-1 Antibody Pembrolizumab.Hutchins, B., Starling, GC., McCoy, MA., et al.[2021]

References

Clinical outcomes of pembrolizumab therapy in advanced-NSCLC patients with poor performance status (≥3) and high PD-L1 expression (TPS ≥50%): A case series. [2021]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Biophysical and Immunological Characterization and In Vivo Pharmacokinetics and Toxicology in Nonhuman Primates of the Anti-PD-1 Antibody Pembrolizumab. [2021]
Pembrolizumab for Patients with Relapsed or Refractory Extranodal NK/T-Cell Lymphoma in Korea. [2023]
Clostridium novyi-NT in cancer therapy. [2020]
Clostridium to treat cancer: dream or reality? [2020]
An intravenous pancreatic cancer therapeutic: Characterization of CRISPR/Cas9n-modified Clostridium novyi-Non Toxic. [2023]
Bacteriolytic therapy of experimental pancreatic carcinoma. [2022]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Pembrolizumab for Previously Treated Advanced or Metastatic Urothelial Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal. [2020]
New developments in the management of advanced melanoma - role of pembrolizumab. [2020]
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