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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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03644550
The ClinicalTrials.gov registry entry for NCT03644550 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03644550 reports 0 study locations.
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.
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