Trial Outcomes & Findings for Pembrolizumab and Magnetic Resonance Imaging With Ferumoxytol in Treating Patients With Non-small Cell Lung Cancer and Brain Metastases (NCT NCT03325166)
NCT ID: NCT03325166
Last Updated: 2022-08-10
Results Overview
Will be analyzed using proportions and exact 95% confidence intervals. Sensitivity analysis will be based on subjects (lesions) with surgical results, and specificity analysis will be based on lesions with pseudo-progression determined based on surgical results or follow-up scan.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2022-08-10
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab, Ferumoxytol MRI)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (or up to 32 cycles) in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI at baseline, 12 weeks after radiation, at suspected radiographic progression, and 6 weeks after suspected radiographic progression.
Ferumoxytol: Given IV
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
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|---|---|
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Overall Study
STARTED
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2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Pembrolizumab, Ferumoxytol MRI)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (or up to 32 cycles) in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI at baseline, 12 weeks after radiation, at suspected radiographic progression, and 6 weeks after suspected radiographic progression.
Ferumoxytol: Given IV
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
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|---|---|
|
Overall Study
Adverse Event
|
1
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Baseline Characteristics
Pembrolizumab and Magnetic Resonance Imaging With Ferumoxytol in Treating Patients With Non-small Cell Lung Cancer and Brain Metastases
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab, Ferumoxytol MRI)
n=2 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (or up to 32 cycles) in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI at baseline, 12 weeks after radiation, at suspected radiographic progression, and 6 weeks after suspected radiographic progression.
Ferumoxytol: Given IV
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
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|---|---|
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Age, Categorical
<=18 years
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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
|
53.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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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
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Due to low accrual and staffing issues, data was not collected for this outcome.
Will be analyzed using proportions and exact 95% confidence intervals. Sensitivity analysis will be based on subjects (lesions) with surgical results, and specificity analysis will be based on lesions with pseudo-progression determined based on surgical results or follow-up scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Due to low accrual and staffing issues, data was not collected for this outcome.
Safety and tolerability will be determined using the Common Terminology Criteria for Adverse Events V4.0 (CTCAE) grades. They will be analyzed using percentages of patients who developed adverse events and exact 95% confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Due to low accrual and staffing issues, data was not collected for this outcome.
The duration of best response in brain and the duration of best response in systemic disease will be measured in months from the date on which criteria are met for complete response, partial response or stable disease until the first date that recurrent or progressive disease is objectively documented. Durations of best response will be analyzed using the Kaplan-Meier product limit estimates, taking censoring into account.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Due to low accrual and staffing issues, data was not collected for this outcome.
Best response in brain disease will be measured based on brain MRI scan showing the best response to treatment and analyzed using proportions of categories of best response (e.g., complete remission, partial remission, progression, stable disease etc.) and exact 95% confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Due to low accrual and staffing issues, data was not collected for this outcome.
Best response in systematic disease will be measured based on body CT scan showing the best response to treatment and analyzed using proportions of categories of best response (e.g., complete remission, partial remission, progression, stable disease etc.) and exact 95% confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Due to low accrual and staffing issues, data was not collected for this outcome.
Progression free survival will be measured in months from the date of diagnosis to the date of documented progression for each patient. Results will be analyzed using the Kaplan-Meier product limit estimates for all patients, taking censoring into account.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Due to low accrual and staffing issues, data was not collected for this outcome.
Overall survival will be measured in months from date of diagnosis to date of death. Results will be analyzed using the Kaplan-Meier product limit estimates for all patients, taking censoring into account.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Pembrolizumab, Ferumoxytol MRI)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Pembrolizumab, Ferumoxytol MRI)
n=2 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (or up to 32 cycles) in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI at baseline, 12 weeks after radiation, at suspected radiographic progression, and 6 weeks after suspected radiographic progression.
Ferumoxytol: Given IV
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
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|---|---|
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Metabolism and nutrition disorders
Hyperglycemia
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50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
Other adverse events
| Measure |
Treatment (Pembrolizumab, Ferumoxytol MRI)
n=2 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (or up to 32 cycles) in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI at baseline, 12 weeks after radiation, at suspected radiographic progression, and 6 weeks after suspected radiographic progression.
Ferumoxytol: Given IV
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
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|---|---|
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Psychiatric disorders
Insomnia
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Eye disorders
Eye disorders- involuntary blinking
|
50.0%
1/2 • Number of events 2 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Infections and infestations
Urinary tract infection
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Infections and infestations
Eye infection
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Psychiatric disorders
Confusion
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 2 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Renal and urinary disorders
Hematuria
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
General disorders
Limb edema
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Investigations
Elevated liver enzymes
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Nervous system disorders
Headache
|
100.0%
2/2 • Number of events 2 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Blood and lymphatic system disorders
Leukocytosis
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Infections and infestations
Tooth infection
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
|
Nervous system disorders
Dysgeusia
|
50.0%
1/2 • Number of events 1 • Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
|
Additional Information
Gerda Teglassy, MD
Oregon Health and Science University
Phone: 503-494-4526
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place