Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma
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|ClinicalTrials.gov Identifier: NCT03644550|
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : March 22, 2019
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.
To test if pembrolizumab given after LMB-100 shrinks tumors in people with pleural or peritoneal mesothelioma.
People ages 18 and older with pleural or peritoneal mesothelioma that has not responded to platinum-based therapy
Participants will be screened with:
Tumor sample. Participants will have a biopsy if one is needed.
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.
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Drug: LMB-100 Biological: Pembrolizumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of the Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma|
|Actual Study Start Date :||December 4, 2018|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||February 28, 2023|
Experimental: 1/LMB- 100+pembrolizumab
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles
Given IV at RP2D on days 1, 3 and 5 of two (2) 21 day cycles.
Given IV at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
- Objective response rate [ Time Frame: Every 6 weeks until disease progression ]Proportion of subjects receiving at least 1 cycle of study therapy and who have had their disease reevaluated that experience partial or complete response per RECIST 1.1 or modified RECIST criteria
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): NCT03644550
|Contact: Yvonne D Mallory, R.N.||(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)|