Trial Outcomes & Findings for Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma (NCT NCT04840615)
NCT ID: NCT04840615
Last Updated: 2024-02-02
Results Overview
RP2D is defined as the highest dose at which fewer than 2 of 6 participants experience a dose-limiting toxicity. A dose-limiting toxicity is defined as any Grade 4 hematological toxicity lasting greater than 5 days. Grade 3 febrile neutropenia, Grade 3 thrombocytopenia associated with bleeding episodes, any Grade 3 or greater, non-hematological toxicity with the following exceptions: tumor lysis syndrome, Grade 3 electrolyte changes associated with clinically significant consequences, Grade 3 nausea and diarrhea which has not received appropriate treatment, isolated Grade 3 fever occurring within 48 hours of LMB-100 infusion and resolving within 48 hours to ≤ Grade 2 and fully resolved within 1 week, alopecia, infusion-related reactions up to and including Grade 3, asymptomatic ≥ Grade 3 lymphopenia, leukopenia, hypoalbuminemia, electrolyte abnormalities resolving within 24 hours, and increase in alkaline phosphatase.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
2 participants
Primary outcome timeframe
21 days after first LMB-100 administration
Results posted on
2024-02-02
Participant Flow
Participant milestones
| Measure |
Dose Level -1: 200 mcg LMB-100
Dose Level -1: 200 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
Biopsy as feasible at screening, Cycle 1 Day 1 and 5, Cycle 2, 3, \& 4 Day 1, and Cycle 4 Day 21 (±7 days).
|
Dose Level 1: 400 mcg LMB-100
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
Biopsy as feasible at screening, Cycle 1 Day 1 and 5, Cycle 2, 3, \& 4 Day 1, and Cycle 4 Day 21 (±7 days).
|
Dose Level 2: 1200 mcg LMB-100
Dose Level 2: 1200 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
Biopsy as feasible at screening, Cycle 1 Day 1 and 5, Cycle 2, 3, \& 4 Day 1, and Cycle 4 Day 21 (±7 days).
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Dose Level -1: 200 mcg LMB-100
Dose Level -1: 200 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
Biopsy as feasible at screening, Cycle 1 Day 1 and 5, Cycle 2, 3, \& 4 Day 1, and Cycle 4 Day 21 (±7 days).
|
Dose Level 1: 400 mcg LMB-100
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
Biopsy as feasible at screening, Cycle 1 Day 1 and 5, Cycle 2, 3, \& 4 Day 1, and Cycle 4 Day 21 (±7 days).
|
Dose Level 2: 1200 mcg LMB-100
Dose Level 2: 1200 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
Biopsy as feasible at screening, Cycle 1 Day 1 and 5, Cycle 2, 3, \& 4 Day 1, and Cycle 4 Day 21 (±7 days).
|
|---|---|---|---|
|
Overall Study
None of the participants completed all 4 cycles.
|
0
|
2
|
0
|
Baseline Characteristics
Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma
Baseline characteristics by cohort
| Measure |
Dose Level 1: 400 mcg LMB-100
n=2 Participants
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
Biopsy as feasible at screening, Cycle 1 Day 1 and 5, Cycle 2, 3, \& 4 Day 1, and Cycle 4 Day 21 (±7 days).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 8.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 days after first LMB-100 administrationRP2D is defined as the highest dose at which fewer than 2 of 6 participants experience a dose-limiting toxicity. A dose-limiting toxicity is defined as any Grade 4 hematological toxicity lasting greater than 5 days. Grade 3 febrile neutropenia, Grade 3 thrombocytopenia associated with bleeding episodes, any Grade 3 or greater, non-hematological toxicity with the following exceptions: tumor lysis syndrome, Grade 3 electrolyte changes associated with clinically significant consequences, Grade 3 nausea and diarrhea which has not received appropriate treatment, isolated Grade 3 fever occurring within 48 hours of LMB-100 infusion and resolving within 48 hours to ≤ Grade 2 and fully resolved within 1 week, alopecia, infusion-related reactions up to and including Grade 3, asymptomatic ≥ Grade 3 lymphopenia, leukopenia, hypoalbuminemia, electrolyte abnormalities resolving within 24 hours, and increase in alkaline phosphatase.
Outcome measures
| Measure |
All Participants in Dose Level 1: 400 mcg LMB-100
n=2 Participants
All participants that received at least one dose of both LMB-100 and Ipilimumab.
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
|
|---|---|
|
Recommended Phase 2 Dose (RP2D) of Intratumorally Administered LMB-100 in Participants With Mesothelioma
|
NA mcg/kg
The RP2D was not determined because the study closed early due to lack of accrual.
|
PRIMARY outcome
Timeframe: Median follow-up: 3.4 months (1.9 months and 5.0 months)Toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. And Grade 5 is death related to adverse event.
Outcome measures
| Measure |
All Participants in Dose Level 1: 400 mcg LMB-100
n=2 Participants
All participants that received at least one dose of both LMB-100 and Ipilimumab.
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
|
|---|---|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 1 Non-Serious Abdominal pain
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 1 Non-Serious Edema limbs
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 1 Non-Serious Fatigue
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 1 Non-Serious Hypoalbuminemia
|
2 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 1 Non-Serious Non-cardiac chest pain
|
2 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 1 Non-Serious Weight gain
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 2 Non-Serious Anemia
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 2 Non-Serious Capillary leak syndrome
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 2 Non-Serious Edema limbs
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 2 Non-Serious Hypoalbuminemia
|
2 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 2 Non-Serious Pneumonitis
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 2 Non-Serious Sinus tachycardia
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 3 Serious and/or Non-Serious Events
|
0 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 4 Serious Pericardial tamponade
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to LMB-100
Grade 5 Serious and/or Non-Serious Events
|
0 Participants
|
PRIMARY outcome
Timeframe: Median follow-up: 3.4 months (1.9 months and 5.0 months)Toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. And Grade 5 is death related to adverse event.
Outcome measures
| Measure |
All Participants in Dose Level 1: 400 mcg LMB-100
n=2 Participants
All participants that received at least one dose of both LMB-100 and Ipilimumab.
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
|
|---|---|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to Ipilimumab
Grade 1 Non-Serious Abdominal pain
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to Ipilimumab
Grade 1 Non-Serious Hypoalbuminemia
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to Ipilimumab
Grade 2 Non-Serious Hypoalbuminemia
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to Ipilimumab
Grade 2 Non-Serious Hypoxia
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to Ipilimumab
Grade 2 Non-Serious Pneumonitis
|
1 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to Ipilimumab
Grade 3 Serious and/or Non-Serious Events
|
0 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to Ipilimumab
Grade 4 Serious and/or Non-Serious Events
|
0 Participants
|
|
Number of Participants Who Experienced Grades 1-5 Serious and/or Non-serious Toxicity Related (= Possibly + Probably + Definitely) to Ipilimumab
Grade 5 Serious and/or Non-Serious Events
|
0 Participants
|
SECONDARY outcome
Timeframe: Median: 3.4 months (1.9 months and 5.0 months).Proportion of participants who experienced an objective response defined as either a partial or complete response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Partial response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Complete response is disappearance of all target lesions.
Outcome measures
| Measure |
All Participants in Dose Level 1: 400 mcg LMB-100
n=2 Participants
All participants that received at least one dose of both LMB-100 and Ipilimumab.
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
|
|---|---|
|
Proportion of Participants Who Experienced an Objective Response Defined as Either a Partial or Complete Response
Partial Response
|
0 proportion of participants
|
|
Proportion of Participants Who Experienced an Objective Response Defined as Either a Partial or Complete Response
Complete Response
|
0 proportion of participants
|
SECONDARY outcome
Timeframe: Median follow-up: 3.4 months (1.9 months and 5.0 months)Duration of response is defined as the median time criteria are met for partial or complete response to the first date that recurrence or progression is documented. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Partial response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Complete response is disappearance of all target lesions. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progressions.
Outcome measures
| Measure |
All Participants in Dose Level 1: 400 mcg LMB-100
n=2 Participants
All participants that received at least one dose of both LMB-100 and Ipilimumab.
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
|
|---|---|
|
Duration of Response
|
NA Months
Since participants had no response, we cannot provide duration of response.
|
SECONDARY outcome
Timeframe: Median: 1.4 months (95% CI: 0.6-2.3 months)Progression free survival is defined as the median time from start of treatment to time of progression or death, whichever occurs first. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progressions.
Outcome measures
| Measure |
All Participants in Dose Level 1: 400 mcg LMB-100
n=2 Participants
All participants that received at least one dose of both LMB-100 and Ipilimumab.
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
|
|---|---|
|
Progression Free Survival
|
1.4 Months
Interval 0.6 to 2.3
|
SECONDARY outcome
Timeframe: Median 3.4 months (1.9 months and 5.0 months).Overall survival is defined as the median time from start of treatment to death from any cause.
Outcome measures
| Measure |
All Participants in Dose Level 1: 400 mcg LMB-100
n=2 Participants
All participants that received at least one dose of both LMB-100 and Ipilimumab.
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
|
|---|---|
|
Overall Survival
|
3.4 Months
Interval 1.9 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 7 months.Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
All Participants in Dose Level 1: 400 mcg LMB-100
n=2 Participants
All participants that received at least one dose of both LMB-100 and Ipilimumab.
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
|
|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
|
2 Participants
|
Adverse Events
Dose Level 1: 400 mcg LMB-100
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Dose Level 1: 400 mcg LMB-100
n=2 participants at risk
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
Biopsy as feasible at screening, Cycle 1 Day 1 and 5, Cycle 2, 3, \& 4 Day 1, and Cycle 4 Day 21 (±7 days).
|
|---|---|
|
General disorders
Death NOS
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Infections and infestations
Lung infection
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pericardial tamponade
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
Other adverse events
| Measure |
Dose Level 1: 400 mcg LMB-100
n=2 participants at risk
Dose Level 1: 400 mcg LMB-100 administered per dose, dose administered on days 1 and 4 of 21-day cycle, cycle 1 in participants with pleural or peritoneal mesothelioma.
Those with pleural or peritoneal mesothelioma receiving intra-tumoral administration of LMB-100 + Ipilimumab for up to 4 cycles.
For infusion related reactions precaution, all participants will be premedicated 30-60 minutes (+ 30 minutes) prior to each LMB-100 administration with the following medications: Diphenhydramine 25-50 mg by mouth (PO) or intravenous (IV) (or alternative antihistamine at adequate dose), Famotidine 20 mg by mouth (PO) or intravenous (IV) (or alternative histamine H2- receptor antagonists (H2) blocker at adequate dose), and Acetaminophen 650 mg by mouth (PO) or intravenous (IV).
Additional infusion precaution at infusions of LMB-100 after Cycle 1 Day 1 (as appropriate): Dexamethasone 20 mg by mouth (PO), 6-12 hours prior to LMB-100 administration OR 10mg, intravenous (IV), 30-60 minutes prior to LMB-100 administration OR equivalent dose of another corticosteroid as clinically indicated.
Biopsy as feasible at screening, Cycle 1 Day 1 and 5, Cycle 2, 3, \& 4 Day 1, and Cycle 4 Day 21 (±7 days).
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
2/2 • Number of events 5 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Immune system disorders
Allergic reaction
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 6 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
2/2 • Number of events 6 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Gastrointestinal disorders
Belching
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Gastrointestinal disorders
Bloating
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Investigations
Blood bilirubin increased
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Vascular disorders
Capillary leak syndrome
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
General disorders
Chills
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Psychiatric disorders
Confusion
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Investigations
Creatinine increased
|
50.0%
1/2 • Number of events 4 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
100.0%
2/2 • Number of events 4 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
General disorders
Edema limbs
|
100.0%
2/2 • Number of events 4 • Date treatment consent signed to date off study, approximately 7 months.
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 4 • Date treatment consent signed to date off study, approximately 7 months.
|
|
General disorders
Fever
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
2/2 • Number of events 6 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
2/2 • Number of events 16 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
2/2 • Number of events 5 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Vascular disorders
Hypotension
|
100.0%
2/2 • Number of events 6 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
2/2 • Number of events 11 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
100.0%
2/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Cardiac disorders
Pericardial effusion
|
50.0%
1/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Cardiac disorders
Sinus tachycardia
|
100.0%
2/2 • Number of events 6 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Infections and infestations
Thrush
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Endocrine disorders
Thyroid stimulating hormone increased
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Nervous system disorders
Tremor
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Investigations
Urine output decreased
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 7 months.
|
|
Investigations
Weight gain
|
50.0%
1/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 7 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place