Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma
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|ClinicalTrials.gov Identifier: NCT04840615|
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : October 5, 2022
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.
To find a safe dose of LMB-100 in combination with ipilimumab when LMB-100 is injected into tumors.
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.
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....
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Biological: LMB-100 Drug: ipilimumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma|
|Actual Study Start Date :||June 11, 2021|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||November 30, 2025|
Experimental: 1/Intratumoral LMB-100 Administration
Those with pleural or peritoneal mesothelioma receiving intratumoral administration of LMB-100 + ipilimumab in for up to 4 cycles (cycles 1 and 2 include LMB-100 plus ipilimumab; cycles 3 and 4 consist of ipilimumab only)
administered into lesion on days 1 and 4 of up to two 21 day cycles
administered intravenously once per cycle in up to four 21 day cycles. Administration will occur in combination with LMB-100 in the first two cycles.
- recommended phase 2 dose [ Time Frame: 21 days after first LMB-100 administration ]The highest dose at which fewer than 2 of 6 subjects experience a dose limiting toxicity
- safety [ Time Frame: through disease progression ]fraction of patients who experience toxicity by grade and type will be tabulated by dose level
- objective response rate [ Time Frame: every 6 weeks until disease progression ]fraction of subjects who experience either a partial or complete response
- duration of response [ Time Frame: disease recurrence or progression ]median time criteria are met for partial or complete response to the first date that recurrence or progression is documented
- progression free survival [ Time Frame: disease progression ]median time from start of treatment to time of progression or death, whichever occurs first
- Overall survival [ Time Frame: death ]median time from start of treatment to death from any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840615
|Contact: Cathy I Wagner, R.N.||(240) email@example.com|
|Contact: Raffit Hassan, M.D.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Raffit Hassan, M.D.||National Cancer Institute (NCI)|