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NCT03644550 · ClinicalTrials.gov registry record · Phase 2
Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT03644550: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03644550 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03644550, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
Background: Treatment outcomes for people with pleural or peritoneal mesothelioma are often poor. The drug LMB-100 can attack and kill cancer cells. The drug pembrolizumab helps the immune system fight cancer. Together, these drugs might help people with these cancers. Objective: To test if pembrolizumab given after LMB-100 shrinks tumors in people with pleural or peritoneal mesothelioma. Eligibility: People ages 18 and older with pleural or peritoneal mesothelioma that has not responded to platinum-based therapy Design: Participants will be screened with: Tumor sample. Participants will have a biopsy if one is needed. Medical history Physical exam Blood, heart, and urine tests X-rays and scans: Participants will lie on a table. A machine will take pictures of the body. Participants will receive LMB-100 by intravenous (IV) on days 1, 3, and 5 of two 21-day cycles. They will be observed for up to 2 hours after each infusion. They will receive drugs like Benadryl, Tylenol, and Zantac to help with side effects. Starting with the 3rd cycle, participants will receive pembrolizumab by IV on day 1 of each 21-day cycle for up to 2 years. Participants will have blood and urine tests, heart tests, and chest x-rays at least once per cycle. They will have scans every 6 weeks. Participants may opt to provide tumor biopsies before starting the first cycle, after 2 cycles of LMB-100, and after 2 cycles of pembrolizumab. Participants will a follow-up visit 4-6 weeks after their last drug dose of the study drug. This includes blood and heart tests and scans. They may then have scans every 6 weeks. Participants will be contacted once a year for follow-up.
Primary Outcome
Number of participants who received at least 1 cycle of study therapy and who had their disease reevaluated that experienced a partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST criteria. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG LMB-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-12-04 |
| Est. Completion | 2020-11-02 |
| Phase | Phase 2 |
Why NCT03644550 stopped before completion
NCT03644550 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03644550 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03644550 about?
NCT03644550 is a clinical study titled "Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma". Background: Treatment outcomes for people with pleural or peritoneal mesothelioma are often poor. The drug LMB-100 can attack and kill cancer cells. The drug pembrolizumab helps the immune system fight cancer. Together, these drugs might help people with these cancers. Objective: To test if pembr...
What is the current status of trial NCT03644550?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2018-12-04. Estimated completion is 2020-11-02.
What interventions are being tested in trial NCT03644550?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), LMB-100 (DRUG).
Who is sponsoring clinical trial NCT03644550?
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 NCT03644550's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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