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Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03644550
Recruitment Status : Terminated (Due to the Food and Drug Administration's recent approval of Nivolumab plus Ipilimumab as first line treatment for Mesothelioma, the principal investigator decided to end the study early (prior to reaching enrollment goal).)
First Posted : August 23, 2018
Results First Posted : December 2, 2021
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Raffit Hassan, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mesothelioma
Interventions Drug: LMB-100
Biological: Pembrolizumab
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1/LMB- 100+Pembrolizumab
Hide Arm/Group Description

LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.

LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.

LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).

Pembrolizumab: Given intravenous (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.

Period Title: Overall Study
Started 18
Completed 0
Not Completed 18
Reason Not Completed
Withdrawal by Subject             3
Progressive disease             15
Arm/Group Title 1/LMB- 100+Pembrolizumab
Hide Arm/Group Description

LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.

LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.

LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial)..

Pembrolizumab: Given intravenous (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.

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  55.6%
>=65 years
8
  44.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
61.62  (12.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
7
  38.9%
Male
11
  61.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic or Latino
1
   5.6%
Not Hispanic or Latino
10
  55.6%
Unknown or Not Reported
7
  38.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
18
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Number of Participants With an Objective Response (Partial Response + Complete Response)
Hide Description Number of participants who received at least 1 cycle of study therapy and who had their disease reevaluated that experienced a partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST criteria. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame Every 6 weeks until disease progression, an average of 3.1 months
Hide Outcome Measure Data
Hide Analysis Population Description
17/18 participants were evaluable for this outcome measure.
Arm/Group Title 1/LMB- 100+Pembrolizumab
Hide Arm/Group Description:

LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.

LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.

LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).

Pembrolizumab: Given intravenous (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.

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response
3
  17.6%
Complete Response
0
   0.0%
2.Secondary Outcome
Title Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Hide Description 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.
Time Frame Date treatment consent signed to date off study, approximately 22 months and 29 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/LMB- 100+Pembrolizumab
Hide Arm/Group Description:

LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.

LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.

LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).

Pembrolizumab: Given intravenous (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.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
18
 100.0%
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression free survival (PFS) is defined as the duration of time from start of treatment to time of progression (on or after pembrolizumab) or death, whichever occurs first. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study.
Time Frame Time from start of treatment to time of progression (on or after pembrolizumab) or death, whichever occurs first, an average of 6.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/LMB- 100+Pembrolizumab
Hide Arm/Group Description:

LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.

LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.

LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).

Pembrolizumab: Given intravenous (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.

Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: Months
7.1
(4.3 to 8.4)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is the time between the first day of treatment to the day of death.
Time Frame Time between the first day of treatment to the day of death, an average of 17 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/LMB- 100+Pembrolizumab
Hide Arm/Group Description:

LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.

LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.

LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).

Pembrolizumab: Given intravenous (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.

Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: Months
17.1
(10.2 to 27.5)
5.Secondary Outcome
Title Duration of Overall Response (DOR)
Hide Description The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is defined as disappearance of all target lesions with no evidence of tumor elsewhere. Partial Response (PR) is defined as at least a 30% decrease in the total tumor measurement.
Time Frame Time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, an average of 3.1 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/LMB- 100+Pembrolizumab
Hide Arm/Group Description:

LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.

LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.

LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).

Pembrolizumab: Given intravenous (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.

Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: Months
3.1
(2.8 to 11.7)
6.Secondary Outcome
Title Percentage of Participants With an Overall Response
Hide Description Percentage of participants who received at least 1 cycle of study therapy and who had their disease reevaluated that experienced a partial or complete response per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST criteria. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame An average of 3.1 months.
Hide Outcome Measure Data
Hide Analysis Population Description
17/18 participants were evaluable for this outcome measure.
Arm/Group Title 1/LMB- 100+Pembrolizumab
Hide Arm/Group Description:

LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.

LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.

LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial)..

Pembrolizumab: Given intravenous (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.

Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: percentage of participants
17.6
Time Frame Date treatment consent signed to date off study, approximately 22 months and 29 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1/LMB- 100+Pembrolizumab
Hide Arm/Group Description

LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.

LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.

LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).

Pembrolizumab: Given intravenous (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.

All-Cause Mortality
1/LMB- 100+Pembrolizumab
Affected / at Risk (%)
Total   9/18 (50.00%)    
Hide Serious Adverse Events
1/LMB- 100+Pembrolizumab
Affected / at Risk (%) # Events
Total   14/18 (77.78%)    
Blood and lymphatic system disorders   
Anemia  1  1/18 (5.56%)  1
Febrile neutropenia  1  1/18 (5.56%)  1
Cardiac disorders   
Atrial fibrillation  1  3/18 (16.67%)  4
Gastrointestinal disorders   
Abdominal pain  1  1/18 (5.56%)  1
Colitis  1  1/18 (5.56%)  1
Nausea  1  1/18 (5.56%)  1
Small intestinal obstruction  1  1/18 (5.56%)  1
Small intestinal perforation  1  1/18 (5.56%)  2
Vomiting  1  1/18 (5.56%)  1
Infections and infestations   
Lung infection  1  1/18 (5.56%)  1
Investigations   
CPK increased  1  1/18 (5.56%)  1
Thyroid stimulating hormone increased  1  1/18 (5.56%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/18 (5.56%)  1
Hypercalcemia  1  1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Non-cardiac chest pain  1  1/18 (5.56%)  1
Rhabdomyolysis  1  1/18 (5.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, death  1  7/18 (38.89%)  7
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  2/18 (11.11%)  2
Tumor pain  1  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/18 (5.56%)  1
Vascular disorders   
Capillary leak syndrome  1  2/18 (11.11%)  2
1
Term from vocabulary, CTCAE (5.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1/LMB- 100+Pembrolizumab
Affected / at Risk (%) # Events
Total   18/18 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  17/18 (94.44%)  109
Febrile neutropenia  1  1/18 (5.56%)  1
Cardiac disorders   
Palpitations  1  1/18 (5.56%)  1
Pericardial effusion  1  3/18 (16.67%)  3
Sinus tachycardia  1  8/18 (44.44%)  12
Ear and labyrinth disorders   
External ear pain  1  1/18 (5.56%)  1
Vertigo  1  1/18 (5.56%)  1
Endocrine disorders   
Hyperthyroidism  1  2/18 (11.11%)  2
Hypothyroidism  1  1/18 (5.56%)  1
Thyroid stimulating hormone increased  1  5/18 (27.78%)  8
Eye disorders   
Dry eye  1  1/18 (5.56%)  1
Eye disorders - Other, specify  1  1/18 (5.56%)  1
Floaters  1  1/18 (5.56%)  1
Gastrointestinal disorders   
Abdominal distension  1  1/18 (5.56%)  1
Abdominal pain  1  7/18 (38.89%)  9
Bloating  1  1/18 (5.56%)  1
Constipation  1  4/18 (22.22%)  4
Diarrhea  1  6/18 (33.33%)  6
Dry mouth  1  2/18 (11.11%)  2
Dyspepsia  1  3/18 (16.67%)  5
Dysphagia  1  2/18 (11.11%)  3
Gastroesophageal reflux disease  1  1/18 (5.56%)  1
Gastrointestinal disorders - Other, Abdominal pain  1  1/18 (5.56%)  1
Gastrointestinal disorders - Other, Alveolar bone loss  1  1/18 (5.56%)  1
Gastrointestinal disorders - Other, Left side jaw pain  1  1/18 (5.56%)  1
Gastrointestinal disorders - Other, Wisdom tooth extraction  1  2/18 (11.11%)  4
Nausea  1  9/18 (50.00%)  18
Oral pain  1  1/18 (5.56%)  1
Small intestinal obstruction  1  1/18 (5.56%)  1
Toothache  1  1/18 (5.56%)  1
Vomiting  1  5/18 (27.78%)  7
General disorders   
Chills  1  1/18 (5.56%)  1
Edema face  1  1/18 (5.56%)  1
Edema limbs  1  3/18 (16.67%)  4
Fatigue  1  10/18 (55.56%)  18
Fever  1  4/18 (22.22%)  6
Generalized edema  1  1/18 (5.56%)  1
Localized edema  1  10/18 (55.56%)  19
Pain  1  5/18 (27.78%)  6
Infections and infestations   
Bacteremia  1  1/18 (5.56%)  1
Folliculitis  1  1/18 (5.56%)  1
Lung infection  1  1/18 (5.56%)  1
Penile infection  1  1/18 (5.56%)  1
Urinary tract infection  1  1/18 (5.56%)  1
Injury, poisoning and procedural complications   
Fall  1  2/18 (11.11%)  2
Infusion related reaction  1  3/18 (16.67%)  3
Investigations   
Activated partial thromboplastin time prolonged  1  7/18 (38.89%)  14
Alanine aminotransferase increased  1  14/18 (77.78%)  21
Alkaline phosphatase increased  1  6/18 (33.33%)  14
Aspartate aminotransferase increased  1  13/18 (72.22%)  24
Blood lactate dehydrogenase increased  1  2/18 (11.11%)  2
CPK increased  1  2/18 (11.11%)  4
Cardiac troponin I increased  1  1/18 (5.56%)  1
Creatinine increased  1  13/18 (72.22%)  32
GGT increased  1  1/18 (5.56%)  2
Investigations - Other, RBC Urin increased  1  1/18 (5.56%)  1
Investigations - Other, WBC Urine  1  1/18 (5.56%)  3
Investigations - Other, pro Brain Natriuretic peptide  1  1/18 (5.56%)  1
Lymphocyte count decreased  1  17/18 (94.44%)  74
Neutrophil count decreased  1  2/18 (11.11%)  6
Platelet count decreased  1  5/18 (27.78%)  9
Weight gain  1  10/18 (55.56%)  16
Weight loss  1  7/18 (38.89%)  13
White blood cell decreased  1  3/18 (16.67%)  3
Metabolism and nutrition disorders   
Anorexia  1  7/18 (38.89%)  9
Hypercalcemia  1  3/18 (16.67%)  9
Hyperglycemia  1  8/18 (44.44%)  38
Hyperkalemia  1  6/18 (33.33%)  10
Hypermagnesemia  1  2/18 (11.11%)  3
Hypernatremia  1  2/18 (11.11%)  3
Hyperphosphatemia  1  4/18 (22.22%)  6
Hyperuricemia  1  3/18 (16.67%)  5
Hypoalbuminemia  1  16/18 (88.89%)  55
Hypocalcemia  1  2/18 (11.11%)  5
Hypoglycemia  1  1/18 (5.56%)  1
Hypokalemia  1  4/18 (22.22%)  4
Hypomagnesemia  1  5/18 (27.78%)  9
Hyponatremia  1  10/18 (55.56%)  33
Hypophosphatemia  1  3/18 (16.67%)  6
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/18 (11.11%)  3
Arthritis  1  1/18 (5.56%)  2
Back pain  1  4/18 (22.22%)  7
Chest wall pain  1  1/18 (5.56%)  1
Flank pain  1  3/18 (16.67%)  4
Generalized muscle weakness  1  1/18 (5.56%)  1
Joint range of motion decreased  1  1/18 (5.56%)  1
Myalgia  1  3/18 (16.67%)  3
Neck pain  1  1/18 (5.56%)  1
Non-cardiac chest pain  1  5/18 (27.78%)  9
Pain in extremity  1  7/18 (38.89%)  9
Rhabdomyolysis  1  1/18 (5.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps)  1 [1]  1/18 (5.56%)  1
Nervous system disorders   
Dizziness  1  6/18 (33.33%)  9
Dysgeusia  1  1/18 (5.56%)  1
Headache  1  9/18 (50.00%)  17
Paresthesia  1  1/18 (5.56%)  4
Peripheral sensory neuropathy  1  1/18 (5.56%)  1
Presyncope  1  1/18 (5.56%)  1
Somnolence  1  1/18 (5.56%)  1
Syncope  1  1/18 (5.56%)  1
Tremor  1  1/18 (5.56%)  1
Psychiatric disorders   
Anxiety  1  2/18 (11.11%)  2
Confusion  1  1/18 (5.56%)  1
Depression  1  1/18 (5.56%)  1
Insomnia  1  4/18 (22.22%)  5
Renal and urinary disorders   
Hematuria  1  2/18 (11.11%)  2
Proteinuria  1  3/18 (16.67%)  6
Urinary frequency  1  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  11/18 (61.11%)  14
Dyspnea  1  4/18 (22.22%)  5
Epistaxis  1  1/18 (5.56%)  1
Hoarseness  1  1/18 (5.56%)  1
Hypoxia  1  1/18 (5.56%)  1
Pleural effusion  1  2/18 (11.11%)  2
Productive cough  1  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/18 (5.56%)  1
Rhinorrhea  1  3/18 (16.67%)  3
Sore throat  1  3/18 (16.67%)  3
Upper respiratory infection  1  1/18 (5.56%)  1
Wheezing  1  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  2/18 (11.11%)  2
Erythema multiforme  1  1/18 (5.56%)  2
Hyperhidrosis  1  3/18 (16.67%)  4
Pain of skin  1  1/18 (5.56%)  1
Papulopustular rash  1  2/18 (11.11%)  2
Pruritus  1  3/18 (16.67%)  3
Rash acneiform  1  1/18 (5.56%)  1
Rash maculo-papular  1  2/18 (11.11%)  4
Skin and subcutaneous tissue disorders - Other, Erythema abigne  1  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders  1 [2]  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders - Other,Left arm distal to IV site  1  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders - Other, Lesion right forearm  1  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders - Other, left shoulder and left leg  1  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders - Other, pimple located on top of gluteal cleft  1  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders - Other, specify  1  1/18 (5.56%)  1
Skin ulceration  1  1/18 (5.56%)  1
Vascular disorders   
Capillary leak syndrome  1  1/18 (5.56%)  1
Flushing  1  2/18 (11.11%)  2
Hot flashes  1  1/18 (5.56%)  1
Hypertension  1  6/18 (33.33%)  17
Hypotension  1  8/18 (44.44%)  10
Thromboembolic event  1  1/18 (5.56%)  1
1
Term from vocabulary, CTCAE (5.0)
Indicates events were collected by systematic assessment
[1]
- Other, Melanoma (noted lesion 4 months ago on right upper arm)
[2]
- Other, Keratosis ( right forearm, left forehead, right eyebrow
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Raffit Hassan
Organization: National Cancer Institute
Phone: 240-760-6232
EMail: hassanr@mail.nih.gov
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Responsible Party: Raffit Hassan, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03644550    
Other Study ID Numbers: 180136
18-C-0136
First Submitted: August 22, 2018
First Posted: August 23, 2018
Results First Submitted: October 13, 2021
Results First Posted: December 2, 2021
Last Update Posted: December 2, 2021