Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma
Public ClinicalTrials.gov record NCT04840615. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I Study of Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: Mesothelioma is a type of cancer. It originates in cells that line human body cavities. Most people have advanced disease when they are diagnosed. Researchers want to see if a combination of drugs can help. Objective: To find a safe dose of LMB-100 in combination with ipilimumab when LMB-100 is injected into tumors. Eligibility: Adults ages 18 and older with malignant pleural or peritoneal mesothelioma, that cannot be cured with surgery and has not responded to standard first-line treatments for mesothelioma. Design: Participants will be screened with: * Tumor biopsy or effusion, if needed * Medical history * Physical exam * Blood and urine tests * Imaging scans * Heart and lung function tests * Pregnancy test, if needed Some screening tests will be repeated during the study. Participants will get LMB-100 on Days 1 and 4 for up to 2 cycles. Each cycle lasts 21 days. They will stay in the hospital for about 8 days each time they get LMB-100. It will be injected into their tumor with needles. Participants will get ipilimumab through a tube that is put in a vein. It will be given on Day 2 of the first 2 cycles and Day 1 of the next 2 cycles. Participants will be assessed for how well they do daily activities. They will give blood and tissue samples for research. Participants will have a safety visit 4 to 6 weeks after the last dose of the study drugs. Then they will have scans every 6 weeks until their disease gets worse. If their tumor gets bigger, they will have phone, video, or email follow-ups every 12 weeks. Participants will be on this study for life....
Study identification
- NCT ID
- NCT04840615
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 2 participants
Conditions and interventions
Conditions
Interventions
- LMB-100 Biological
- ipilimumab Drug
- Diphenhydramine Drug
- Famotidine Drug
- Acetaminophen Drug
- Dexamethasone Drug
- Biopsy Procedure
- FDG-PET Diagnostic Test
- CT CAP Diagnostic Test
- MRI Diagnostic Test
- ECG Diagnostic Test
- Echocardiogram Diagnostic Test
Biological · Drug · Procedure + 1 more
Eligibility (public fields only)
- Age range
- 18 Years to 120 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 10, 2021
- Primary completion
- Dec 5, 2021
- Completion
- Jan 11, 2022
- Last update posted
- Feb 1, 2024
2021 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04840615, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 1, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04840615 live on ClinicalTrials.gov.