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Checkpoint Inhibitor
LMB-100 + Ipilimumab for Mesothelioma
Phase 1
Waitlist Available
Led By Raffit Hassan, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up median: 1.4 months (95% ci: 0.6-2.3 months)
Awards & highlights
Study Summary
This trial is testing a combination of drugs to see if it is safe and effective in treating mesothelioma.
Eligible Conditions
- Mesothelioma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ median: 1.4 months (95% ci: 0.6-2.3 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~median: 1.4 months (95% ci: 0.6-2.3 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to Ipilimumab
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Recommended Phase 2 Dose (RP2D) of Intratumorally Administered LMB-100 in Participants With Mesothelioma
Secondary outcome measures
Duration of Response
Overall Survival
Progression Free Survival
+1 moreOther outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Side effects data
From 2021 Phase 1 & 2 trial • 40 Patients • NCT0281041850%
Proteinuria
33%
Platelet count decreased
33%
Vomiting
33%
Weight gain
17%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, pancreatic cancer
17%
Pleural effusion
17%
Skin and subcutaneous tissue disorders - Other, buttock excoriation
17%
Sinus tachycardia
17%
Wheezing
17%
Right ventricular dysfunction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in 10
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1,Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1/Intra-tumoral LMB-100 AdministrationExperimental Treatment12 Interventions
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + ipilimumab for up to 4 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FDG-PET
2008
Completed Phase 4
~600
MRI
2009
Completed Phase 2
~1370
Biopsy
2014
Completed Phase 4
~850
Echocardiogram
2016
Completed Phase 2
~1870
Diphenhydramine
2002
Completed Phase 4
~1170
Famotidine
2005
Completed Phase 4
~1700
Acetaminophen
2017
Completed Phase 4
~2030
Dexamethasone
2007
Completed Phase 4
~2590
ECG
2016
Completed Phase 4
~33710
LMB-100
2019
Completed Phase 2
~80
ipilimumab
2016
Completed Phase 3
~5520
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,151 Total Patients Enrolled
93 Trials studying Mesothelioma
8,653 Patients Enrolled for Mesothelioma
Raffit Hassan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
2,175 Total Patients Enrolled
10 Trials studying Mesothelioma
2,173 Patients Enrolled for Mesothelioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical activity takes too long to reset.You have had lung inflammation in the past that needed steroids, or you currently have lung inflammation.You have HIV.You have a current infection of Hepatitis B or C.You have another type of cancer that has been getting worse or needed treatment in the last 2 years.You have a disease that can be treated with an injection of LMB-100 directly into the tumor.You have taken LMB-100 before.You have had a very serious allergic reaction to anti-CTLA4 therapies or any of their ingredients.You have a measurable disease according to specific guidelines, even if the disease is in an area previously treated with radiation.You have had radiation treatment in the area where the study drug will be given.You have a tumor tissue sample available, or you can get a new biopsy of a tumor that hasn't been treated with radiation before. It's best if the sample is in a tissue block, but slides or a new biopsy are also okay.Your tumor must be a specific type determined by a special lab test. If your tumor has two different types, one of them must make up more than half of the tumor.You must have received certain types of cancer treatments in the past, including immune checkpoint therapy and platinum-based chemotherapy.You should be in good physical condition with few or no symptoms from your cancer. This will be checked within 28 days before starting the study treatment.Your kidney function should be calculated according to the hospital's standard method.Your heart's pumping function should be good, with a measurement of more than 50%.You have mesothelioma that cannot be treated with surgery to potentially cure it.You currently have an infection that needs treatment with medication throughout your body.You have cancer that has spread to your brain or spinal cord.You have a significant buildup of fluid around your heart.You are currently taking medication to prevent blood clots.You have a condition that weakens your immune system, or you are taking strong medication that weakens your immune system.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Intra-tumoral LMB-100 Administration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there additional instances of scientific research involving LMB-100?
"The current clinical landscape for LMB-100 is quite robust, with 318 ongoing studies and 38 in the advanced phase 3. Pittsburgh, Pennsylvania has a considerable number of trials operating however there are over 20362 sites providing care to patients worldwide."
Answered by AI
What is the aggregate number of participants involved in this experiment?
"Affirmative. The clinical trial website indicates that this trial is actively recruiting patients and has been since June 11th 2021. As of October 4 2022, the study seeks 20 participants from a single location."
Answered by AI
What outcomes is this experiment aiming to manifest?
"The primary objective of this 21-day experiment is to evaluate the safety of LMB-100. Secondary endpoints are defined as the fraction of participants that experience a partial or complete response, median time from initial treatment to death due to any cause (overall survival), and average length between meeting criteria for response and documentation of recurrence/progression (duration of response)."
Answered by AI
What therapeutic indications does LMB-100 usually address?
"LMB-100 is the go-to treatment for cutaneous melanoma and can be beneficial in treating complete resection, liver carcinoma, and metastatic melanoma."
Answered by AI
Is there an opportunity to join this experiment at the present time?
"Per the clinicaltrials.gov portal, this study is still open for enrollment and has been since June 11th 2021. The details of the trial were last revised in October 4 2022."
Answered by AI
Has LMB-100 acquired the approval of the Food and Drug Administration?
"There is only limited evidence for the safety and efficacy of LMB-100, so it has been given a score of 1."
Answered by AI
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