Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma
Status:
Completed
Trial end date:
2020-11-17
Target enrollment:
Participant gender:
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 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.