Trial Outcomes & Findings for LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (NCT NCT04027946)

Last Updated: 2024-04-16

Results Overview

Participants with a partial response or complete response is reported with an 80% confidence interval. Response was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response is disappearance of all target lesions. 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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

End of treatment, an average of 83 days.

Results posted on

2024-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.
Overall Study STARTED	6
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.
Overall Study Screen failures	3

Baseline Characteristics

LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants n=6 Participants LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.
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	5 Participants n=5 Participants
Age, Continuous	67.12 years STANDARD_DEVIATION 7.07 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 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	1 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	2 Participants n=5 Participants
Race (NIH/OMB) White	3 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	6 participants n=5 Participants

PRIMARY outcome

Timeframe: End of treatment, an average of 83 days.

Population: 3/6 participants were analyzed because 3 were screen failures.

Outcome measures

Outcome measures
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants n=3 Participants LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.	Grade 3 Probably Related Grade 3 is severe.	Grade 3 Definitely Related Grade 3 is severe.	Grade 4 Possibly Related Grade 4 is life- threatening.	Grade 4 Probably Related Grade 4 is life- threatening.	Grade 4 Definitely Related Grade 4 is life- threatening.
Proportion of Participants With Partial Response or Complete Response Reported With an 80% Confidence Interval	0 proportion of participants Interval 0.0 to 0.0	—	—	—	—	—

PRIMARY outcome

Timeframe: End of treatment, an average of 83 days.

Population: 3/6 participants were analyzed because 3 were screen failures.

Participants with a partial response or complete response is reported with an 95% confidence interval. Response was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response is disappearance of all target lesions. 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.

Outcome measures

Outcome measures
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants n=3 Participants LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.	Grade 3 Probably Related Grade 3 is severe.	Grade 3 Definitely Related Grade 3 is severe.	Grade 4 Possibly Related Grade 4 is life- threatening.	Grade 4 Probably Related Grade 4 is life- threatening.	Grade 4 Definitely Related Grade 4 is life- threatening.
Proportion of Participants With Partial Response or Complete Response Reported With an 95% Confidence Interval	0 proportion of participants Interval 0.0 to 0.0	—	—	—	—	—

SECONDARY outcome

Timeframe: From the start of the treatment until disease progression/recurrence (taking as reference for progressive disease), an median of 22.9 months.

Population: 3/6 participants were analyzed because 3 were screen failures.

The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The participant's best response assignment will depend on the achievement of both measurement and confirmation criteria. Response was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome measures
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants n=3 Participants LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.	Grade 3 Probably Related Grade 3 is severe.	Grade 3 Definitely Related Grade 3 is severe.	Grade 4 Possibly Related Grade 4 is life- threatening.	Grade 4 Probably Related Grade 4 is life- threatening.	Grade 4 Definitely Related Grade 4 is life- threatening.
Overall Response (OR) Complete Response	0 Participants	—	—	—	—	—
Overall Response (OR) Partial Response	0 Participants	—	—	—	—	—
Overall Response (OR) Stable Disease	2 Participants	—	—	—	—	—
Overall Response (OR) Progressive Disease	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Beginning at the date a participant is noted to have at least a partial response (PR), an average of 2.7 months.

Population: 3/6 participants were analyzed because 3 were screen failures.

Response was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome measures
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants n=3 Participants LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.	Grade 3 Probably Related Grade 3 is severe.	Grade 3 Definitely Related Grade 3 is severe.	Grade 4 Possibly Related Grade 4 is life- threatening.	Grade 4 Probably Related Grade 4 is life- threatening.	Grade 4 Definitely Related Grade 4 is life- threatening.
Number of Participants With a Response Complete Response	0 Participants	—	—	—	—	—
Number of Participants With a Response Partial Response	0 Participants	—	—	—	—	—
Number of Participants With a Response Stable Disease	2 Participants	—	—	—	—	—
Number of Participants With a Response Progressive Disease	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Time from start of treatment to time of progression (on or after pembrolizumab) or death, whichever occurs first, calculated from the on-study date using the Kaplan-Meier method, an average of 2.7 months.

Population: 3/6 participants were analyzed because 3 were screen failures.

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, calculated from the on-study date using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants n=3 Participants LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.	Grade 3 Probably Related Grade 3 is severe.	Grade 3 Definitely Related Grade 3 is severe.	Grade 4 Possibly Related Grade 4 is life- threatening.	Grade 4 Probably Related Grade 4 is life- threatening.	Grade 4 Definitely Related Grade 4 is life- threatening.
Progression Free Survival (PFS)	3.0 Months Interval 3.0 to 4.3	—	—	—	—	—

SECONDARY outcome

Timeframe: Time from the start of treatment to death from any cause, a median of 22.9 months

Overall survival is defined as the duration of time from start of treatment to death from any cause.

Outcome measures

Outcome measures
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants n=3 Participants LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.	Grade 3 Probably Related Grade 3 is severe.	Grade 3 Definitely Related Grade 3 is severe.	Grade 4 Possibly Related Grade 4 is life- threatening.	Grade 4 Probably Related Grade 4 is life- threatening.	Grade 4 Definitely Related Grade 4 is life- threatening.
Overall Survival	22.9 Months Interval 3.2 to 39.3	—	—	—	—	—

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 48.7 months

Population: 3/6 participants were analyzed because 3 were screen failures.

Adverse events were evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 3 is severe. Grade 4 is life-threatening.

Outcome measures

Outcome measures
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants n=3 Participants LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.	Grade 3 Probably Related n=3 Participants Grade 3 is severe.	Grade 3 Definitely Related n=3 Participants Grade 3 is severe.	Grade 4 Possibly Related n=3 Participants Grade 4 is life- threatening.	Grade 4 Probably Related n=3 Participants Grade 4 is life- threatening.	Grade 4 Definitely Related n=3 Participants Grade 4 is life- threatening.
Proportion of Participants With Grade 3 and Grade 4 Adverse Events Possibly, Probably, and Definitely Related to LMB-100	0 proportion of participants	0 proportion of participants	0 proportion of participants	0 proportion of participants	0 proportion of participants	0 proportion of participants

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 48.7 months

Adverse events were evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 3 is severe. Grade 4 is life-threatening.

Outcome measures

Outcome measures
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants n=3 Participants LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.	Grade 3 Probably Related n=3 Participants Grade 3 is severe.	Grade 3 Definitely Related n=3 Participants Grade 3 is severe.	Grade 4 Possibly Related n=3 Participants Grade 4 is life- threatening.	Grade 4 Probably Related n=3 Participants Grade 4 is life- threatening.	Grade 4 Definitely Related n=3 Participants Grade 4 is life- threatening.
Proportion of Participants With Grade 3 and Grade 4 Adverse Events Possibly, Probably, and Definitely Related to Pembrolizumab	0 proportion of participants	0 proportion of participants	0 proportion of participants	0 proportion of participants	0 proportion of participants	0 proportion of participants

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 48.7 months

Population: 3/6 participants were analyzed because 3 were screen failures.

Participants who are treated who are unable to tolerate the treatment other than development of adverse events

Outcome measures

Outcome measures
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants n=3 Participants LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.	Grade 3 Probably Related Grade 3 is severe.	Grade 3 Definitely Related Grade 3 is severe.	Grade 4 Possibly Related Grade 4 is life- threatening.	Grade 4 Probably Related Grade 4 is life- threatening.	Grade 4 Definitely Related Grade 4 is life- threatening.
Number of Participants Who Are Treated Who Are Unable to Tolerate the Treatment Other Than Development of Adverse Events	0 Participants	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 48.7 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

Outcome measures
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants n=3 Participants LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.	Grade 3 Probably Related Grade 3 is severe.	Grade 3 Definitely Related Grade 3 is severe.	Grade 4 Possibly Related Grade 4 is life- threatening.	Grade 4 Probably Related Grade 4 is life- threatening.	Grade 4 Definitely Related Grade 4 is life- threatening.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	3 Participants	—	—	—	—	—

Adverse Events

Mesothelin Expressing Non-Small Cell Lung Cancer Participants

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants n=3 participants at risk LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Metabolism and nutrition disorders Anorexia	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.

Other adverse events

Other adverse events
Measure	Mesothelin Expressing Non-Small Cell Lung Cancer Participants n=3 participants at risk LMB-100 + Pembrolizumab LMB-100: Participants will receive LMB-100 140mcg/kg on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles. Pembrolizumab: Participants will receive 200 mg pembrolizumab on day 1 of each subsequent 21-day cycle for up to 2 years or until disease progression. Mesothelin Expression: Testing for mesothelin expression performed at screening. TrueSight Oncology 500: Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Investigations Activated partial thromboplastin time prolonged	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Blood and lymphatic system disorders Anemia	100.0% 3/3 • Number of events 11 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Investigations Aspartate aminotransferase increased	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Respiratory, thoracic and mediastinal disorders Atelectasis	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Investigations Blood lactate dehydrogenase increased	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Investigations CPK increased	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Vascular disorders Capillary leak syndrome	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Psychiatric disorders Confusion	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Investigations Creatinine increased	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 3/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
General disorders Edema limbs	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Cardiac disorders Electrocardiogram QT corrected interval prolonged	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Eye disorders Eye pain	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
General disorders Fatigue	66.7% 2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
General disorders Fever	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Nervous system disorders Headache	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Renal and urinary disorders Hematuria	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 3/3 • Number of events 9 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Metabolism and nutrition disorders Hypomagnesemia	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Metabolism and nutrition disorders Hyponatremia	100.0% 3/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Vascular disorders Hypotension	66.7% 2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Investigations Lymphocyte count decreased	100.0% 3/3 • Number of events 7 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Gastrointestinal disorders Mucositis oral	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
General disorders Pain	33.3% 1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Investigations Platelet count decreased	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	66.7% 2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Respiratory, thoracic and mediastinal disorders Productive cough	33.3% 1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Renal and urinary disorders Proteinuria	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Cardiac disorders Sinus tachycardia	100.0% 3/3 • Number of events 7 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Respiratory, thoracic and mediastinal disorders Sore throat	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Infections and infestations Thrush	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Infections and infestations Upper respiratory infection	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Infections and infestations Urinary tract infection	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.
Investigations Weight gain	66.7% 2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 48.7 months. 3/6 participants were analyzed because 3 were screen failures. There were 3 deaths due to progression and not related to the study.

Additional Information

Dr. Azam Ghafoor

National Cancer Institute

Phone: 240-858-3289

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place