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Virus Therapy
Pembrolizumab + Clostridium Novyi-NT for Cancer
Phase 1
Recruiting
Led By Sarina Piha-Paul, MD, PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of prior treatment with at least one line of systemic anticancer therapy when no curative option is available
Diagnosis of an advanced solid tumor malignancy with a target tumor measurable, palpable, or identifiable under ultrasound or radiographic guidance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
This trial is studying a bacteria that's been genetically changed to remove chemicals that are poisonous to humans, in order to see if it can help chemotherapy drugs fight cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include reactions related to bacterial infection, typical immune response issues from pembrolizumab like inflammation in organs or skin, fatigue, and possibly complications from combining both treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had at least one cancer treatment when cure wasn't an option.
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My advanced cancer can be seen or felt, or identified with imaging.
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My cancer has a visible tumor larger than 1 cm but smaller than 12 cm.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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I understand the study and can agree to participate.
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I can stay within 45 minutes of an ER for 28 days after my treatment.
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My cancer has not spread to the bones at the target lesion site.
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My organ functions are within normal ranges.
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My heart valves are healthy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of Intratumoral Injection of Clostridium Novyi-NT with Pembrolizumab
Secondary outcome measures
Preliminary Anti-Tumor Activity of Pembrolizumab in Combination with C. novyi-NT in the Injected Tumor and an Overall Response by RECIST 1.1
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Doxycycline
2008
Completed Phase 4
~2430
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,299 Total Patients Enrolled
BioMed Valley Discoveries, IncIndustry Sponsor
16 Previous Clinical Trials
720 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,039 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have had my spleen removed.I've had at least one cancer treatment when cure wasn't an option.I have not had a stroke or heart attack in the last year.I have not taken antibiotics in the last 2 weeks.Your average blood pressure is less than 70 mmHg.You have a Glasgow Coma Score lower than 15.I have had lung inflammation treated with steroids or have it now.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.It has been over 4 weeks since my major surgery and I have fully recovered.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 am not pregnant and use birth control.I can stay within 45 minutes of an ER for 28 days after my treatment.My tumor sample will be tested for PD-L1 and immune response.My organ functions are within normal ranges.I have someone to take care of me for 28 days after my treatment.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.My cancer has not spread to the bones at the target lesion site.My heart valves are healthy.I have an autoimmune disease but haven't needed strong medication for it.I have a confirmed brain tumor or cancer that has spread to my brain.You had a bad allergic reaction to another type of medication called mAb.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.I haven't had chemotherapy, radiation, or biological therapy in the last 4 weeks.You are allergic to antibiotics that are needed to treat a C. novyi-NT infection.You have a foreign object inside your body that could be hard to treat if it gets infected.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Clostridium novyi-NT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical ailments does the use of Clostridium Novyi-NT typically address?
"Clostridium Novyi-NT is the most commonly employed medication for treating severe acne. Additionally, this drug can be beneficial to those with unresectable melanoma, high microsatellite instability and augmented risk of recurrence."
Answered by AI
What risks are associated with utilizing Clostridium Novyi-NT for medical treatment?
"Clostridium Novyi-NT is still in its initial clinical trial phase, and therefore the safety of this drug has been assigned a score of 1. This indicates that there is limited data available with regards to both efficacy and safety."
Answered by AI
Is enrollment to this trial currently available?
"Affirmative. Clinicaltrials.gov reveals that this medical investigation, which was first publicized on July 10th 2018, is now actively recruiting patients to its ranks. 18 participants are necessary for the study at one single site."
Answered by AI
How many participants are being monitored for this research project?
"Affirmative. Clinicaltrials.gov displays that this clinical trial is actively searching for participants, with the initial posting taking place on July 10th 2018 and being updated as recently as April 18th 2022. The study requires recruitment of 18 volunteers from a single facility."
Answered by AI
Which other experiments have been undertaken to evaluate the efficacy of Clostridium Novyi-NT?
"Currently, there are 999 studies on Clostridium Novyi-NT with 129 in their final phase. The study is mainly concentrated around Houston, Texas but also encompasses 35,833 locations worldwide."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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