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NCT04840615 · ClinicalTrials.gov registry record · Phase 1
Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04840615: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT04840615 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04840615, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
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....
Primary Outcome
RP2D is defined as the highest dose at which fewer than 2 of 6 participants experience a dose-limiting toxicity. A dose-limiting toxicity is defined as any Grade 4 hematological toxicity lasting greater than 5 days. Grade 3 febrile neutropenia, Grade 3 thrombocytopenia associated with bleeding episodes, any Grade 3 or greater, non-hematological toxicity with the following exceptions: tumor lysis syndrome, Grade 3 electrolyte changes associated with clinically significant consequences, Grade 3 na
Interventions
- DRUG Acetaminophen
- DRUG Diphenhydramine
- DRUG Famotidine
- DRUG ipilimumab
- BIOLOGICAL LMB-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2021-06-11 |
| Est. Completion | 2022-01-12 |
| Phase | Phase 1 |
Why NCT04840615 stopped before completion
NCT04840615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT04840615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04840615 about?
NCT04840615 is a clinical study titled "Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma". 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 ...
What is the current status of trial NCT04840615?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2021-06-11. Estimated completion is 2022-01-12.
What interventions are being tested in trial NCT04840615?
The interventions under investigation include: Acetaminophen (DRUG), Diphenhydramine (DRUG), Famotidine (DRUG), ipilimumab (DRUG), LMB-100 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04840615?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04840615's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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