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Virus Therapy

Pembrolizumab + Clostridium Novyi-NT for Cancer

Phase 1

Waitlist Available

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

Must not have

Need for ongoing treatment with an immunosuppressive agent

History of asplenia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need to take medication that weakens my immune system.

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I have had my spleen removed.

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

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I am currently on medication for an infection.

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

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

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) of Intratumoral Injection of Clostridium Novyi-NT with Pembrolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3150

Doxycycline

2008

Completed Phase 4

~2650