Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma
Status:
Recruiting
Trial end date:
2025-11-30
Target enrollment:
Participant gender:
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....