Trial Outcomes & Findings for Ferumoxytol MRI in Assessing Response to Pembrolizumab in Patients With Glioblastoma (NCT NCT03347617)
NCT ID: NCT03347617
Last Updated: 2025-09-09
Results Overview
Sensitivity and specificity are measures for the diagnostic performance of rCBV (relative cerebral blood volume) to distinguish between pseudoprogression and true progression. Sensitivity measures how well Fe-SS-rCBV identifies those who have true progression, and specificity those who have psuedoprogression. Because rCBV is a continuous variable, the cutoff point for this analysis was 1.75.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
At suspected progression, up to two years.
Results posted on
2025-09-09
Participant Flow
Participant milestones
| Measure |
Diagnostic (Ferumoxytol MRI, Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
Ferumoxytol: Given IV
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo ferumoxytol MRI
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ferumoxytol MRI in Assessing Response to Pembrolizumab in Patients With Glioblastoma
Baseline characteristics by cohort
| Measure |
Diagnostic (Ferumoxytol MRI, Pembrolizumab)
n=52 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
Ferumoxytol: Given IV
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo ferumoxytol MRI
Pembrolizumab: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 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
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At suspected progression, up to two years.Population: A total of 12 out of 52 participants were evaluable to allow calculation of specificity to distinguish true progression from pseudo-progression based on steady state rCBV at suspected progression
Sensitivity and specificity are measures for the diagnostic performance of rCBV (relative cerebral blood volume) to distinguish between pseudoprogression and true progression. Sensitivity measures how well Fe-SS-rCBV identifies those who have true progression, and specificity those who have psuedoprogression. Because rCBV is a continuous variable, the cutoff point for this analysis was 1.75.
Outcome measures
| Measure |
Diagnostic (Ferumoxytol MRI, Pembrolizumab)
n=12 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
Ferumoxytol: Given IV Laboratory Biomarker Analysis: Correlative studies Magnetic Resonance Imaging: Undergo ferumoxytol MRI Pembrolizumab: Given IV
|
|---|---|
|
Specificity of Identifying Pseudoprogression
|
58.3 percentage
Interval 27.9 to 84.8
|
PRIMARY outcome
Timeframe: At suspected progression, up to two years.Population: A total of 15 out of 52 participants were evaluable to allow calculation of sensitivity to distinguish true progression from pseudo-progression based on steady state rCBV at suspected progression
The calculation of sensitivity is based on steady state rCBV (relative cerebral blood volume) at suspected progression. Cutoff point 1.75. Sensitivity and specificity are measures for the diagnostic performance of rCBV (relative cerebral blood volume) to distinguish between pseudoprogression and true progression. Sensitivity measures how well Fe-SS-rCBV identifies those who have true progression, and specificity those who have psuedoprogression. Because rCBV is a continuous variable, the cutoff point for this analysis was 1.75.
Outcome measures
| Measure |
Diagnostic (Ferumoxytol MRI, Pembrolizumab)
n=15 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
Ferumoxytol: Given IV Laboratory Biomarker Analysis: Correlative studies Magnetic Resonance Imaging: Undergo ferumoxytol MRI Pembrolizumab: Given IV
|
|---|---|
|
Sensitivity of Identifying True Progression
|
46.7 percentage
Interval 21.3 to 73.4
|
SECONDARY outcome
Timeframe: Until off study, up to 5 years.Population: All enrolled subjects
Will be assessed using the Kaplan-Meier product limit estimates. Response assessment was completed based on a modified version of the Response Assessment in Neuro-Oncology (RANO) criteria.
Outcome measures
| Measure |
Diagnostic (Ferumoxytol MRI, Pembrolizumab)
n=52 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
Ferumoxytol: Given IV Laboratory Biomarker Analysis: Correlative studies Magnetic Resonance Imaging: Undergo ferumoxytol MRI Pembrolizumab: Given IV
|
|---|---|
|
Progression Free Survival
|
10.4 Months
Interval 7.1 to 11.7
|
SECONDARY outcome
Timeframe: Until off study, up to 5 years.Population: All enrolled subjects
Will be assessed using the Kaplan-Meier product limit estimates.
Outcome measures
| Measure |
Diagnostic (Ferumoxytol MRI, Pembrolizumab)
n=52 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
Ferumoxytol: Given IV Laboratory Biomarker Analysis: Correlative studies Magnetic Resonance Imaging: Undergo ferumoxytol MRI Pembrolizumab: Given IV
|
|---|---|
|
Overall Survival
|
15.2 Months
Interval 12.5 to 17.1
|
SECONDARY outcome
Timeframe: Until off study, up to 5 years.Population: All enrolled subjects
Will be analyzed using the Kaplan-Meier product limit estimates. Response assessment was completed based on a modified version of the Response Assessment in Neuro-Oncology (RANO) criteria.
Outcome measures
| Measure |
Diagnostic (Ferumoxytol MRI, Pembrolizumab)
n=52 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
Ferumoxytol: Given IV Laboratory Biomarker Analysis: Correlative studies Magnetic Resonance Imaging: Undergo ferumoxytol MRI Pembrolizumab: Given IV
|
|---|---|
|
Duration of Best Response
|
6.4 Months
Interval 4.1 to 8.5
|
SECONDARY outcome
Timeframe: Until off study, up to 5 years.Population: Of the 52 enrolled patients, 43 were evaluable (9 replaced).
Disease response was assessed based on a modified version of the Response Assessment in Neuro-Oncology (RANO) criteria.
Outcome measures
| Measure |
Diagnostic (Ferumoxytol MRI, Pembrolizumab)
n=43 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
Ferumoxytol: Given IV Laboratory Biomarker Analysis: Correlative studies Magnetic Resonance Imaging: Undergo ferumoxytol MRI Pembrolizumab: Given IV
|
|---|---|
|
Disease Response
Partial response
|
18 Participants
|
|
Disease Response
Stable disease
|
9 Participants
|
|
Disease Response
Disease progression
|
8 Participants
|
|
Disease Response
Complete response
|
8 Participants
|
SECONDARY outcome
Timeframe: 30 days after last dose of pembrolizumab, up to 2 years.Population: Out of 52 participants, 29 experienced an adverse event greater than or equal to grade 3 that were possibly related or related to pembrolizumab.
Number of participants with adverse events possibly related or related to pembrolizumab in combination with standard of care. Will be analyzed using proportions and exact 95% confidence intervals.
Outcome measures
| Measure |
Diagnostic (Ferumoxytol MRI, Pembrolizumab)
n=52 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
Ferumoxytol: Given IV Laboratory Biomarker Analysis: Correlative studies Magnetic Resonance Imaging: Undergo ferumoxytol MRI Pembrolizumab: Given IV
|
|---|---|
|
Determine the Safety and Toxicity of Pembrolizumab When Used in Combination With Standard of Care Chemo Radiation.
Grade 3 or above possibly related to pembrolizumab
|
27 participants
|
|
Determine the Safety and Toxicity of Pembrolizumab When Used in Combination With Standard of Care Chemo Radiation.
Grade 3 or above related to pembrolizumab
|
2 participants
|
Adverse Events
Diagnostic (Ferumoxytol MRI, Pembrolizumab)
Serious events: 15 serious events
Other events: 51 other events
Deaths: 45 deaths
Serious adverse events
| Measure |
Diagnostic (Ferumoxytol MRI, Pembrolizumab)
n=52 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
Ferumoxytol: Given IV
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo ferumoxytol MRI
Pembrolizumab: Given IV
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
General disorders
Flu like symptoms
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Encephalopathy
|
3.8%
2/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Infections and infestations
Sepsis
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Vascular disorders
Thromboembolic event
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Edema cerebral
|
3.8%
2/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Seizures
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.8%
2/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Cognitive disturbance
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Tremor
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Psychiatric disorders
Confusion
|
3.8%
2/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Aphasia
|
3.8%
2/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Infections and infestations
Appendicitis
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Pleocytosis
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Investigations
Neutrophil count decreased
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Investigations
White blood cell count decreased
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Colonic perforation
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Infections and infestations
Wound infection
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify - altered mental status
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Eye disorders
Eye lid function disorder - drooping
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
General disorders
Gait disturbance
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Facial muscle weakness
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Dysarthria
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
1/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
Other adverse events
| Measure |
Diagnostic (Ferumoxytol MRI, Pembrolizumab)
n=52 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
Ferumoxytol: Given IV
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo ferumoxytol MRI
Pembrolizumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
46.2%
24/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
CD4 lymphocytes decreased
|
11.5%
6/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
17.3%
9/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
78.8%
41/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
9.6%
5/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
59.6%
31/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
11.5%
6/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Ear and labyrinth disorders
Ear pain
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.7%
4/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Endocrine disorders
Hyperthyroidism
|
9.6%
5/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Endocrine disorders
Hypothyroidism
|
11.5%
6/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Eye disorders
Blurred vision
|
21.2%
11/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Eye disorders
Other eye disorders
|
9.6%
5/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Alanine aminotransferase increased
|
48.1%
25/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Alkaline phosphatase increased
|
17.3%
9/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Anorexia
|
19.2%
10/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Aspartate aminotransferase increased
|
34.6%
18/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Constipation
|
53.8%
28/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
13/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
4/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
57.7%
30/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Stomach pain
|
11.5%
6/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
17.3%
9/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
General disorders
Chills
|
13.5%
7/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
General disorders
Edema
|
11.5%
6/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
General disorders
Fatigue
|
73.1%
38/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
General disorders
Fever
|
9.6%
5/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
General disorders
Localized edema
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
General disorders
Non-cardiac chest pain
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
General disorders
Weight loss
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Infections and infestations
Sepsis
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
15.4%
8/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
9.6%
5/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Injury, poisoning and procedural complications
Fall
|
21.2%
11/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
4/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
38.5%
20/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.7%
4/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
9.6%
5/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.5%
7/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
26.9%
14/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
9.6%
5/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.5%
7/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.6%
5/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
LDH increased
|
40.4%
21/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
13/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
8/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
21.2%
11/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
4/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.5%
6/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Ataxia
|
9.6%
5/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Dizziness
|
21.2%
11/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Dysarthria
|
11.5%
6/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Dysgeusia
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Gait disturbance
|
17.3%
9/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Headache
|
50.0%
26/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Memory impairment
|
36.5%
19/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
13.5%
7/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Paresthesia
|
17.3%
9/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Seizure
|
23.1%
12/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Nervous system disorders
Tremor
|
7.7%
4/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Psychiatric disorders
Agitation
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Psychiatric disorders
Anxiety
|
21.2%
11/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Psychiatric disorders
Confusion
|
7.7%
4/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Psychiatric disorders
Depression
|
17.3%
9/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Psychiatric disorders
Insomnia
|
7.7%
4/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Renal and urinary disorders
Urinary frequency
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Renal and urinary disorders
Urinary urgency
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.2%
10/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.5%
7/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.7%
4/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.8%
16/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Vascular disorders
Hematoma
|
5.8%
3/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Vascular disorders
Hypotension
|
11.5%
6/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
|
Vascular disorders
Thromboembolic event
|
13.5%
7/52 • All AEs were recorded up to 30 days after last pembrolizumab (maximum treatment of pembrolizumab is 2 years) except all-cause mortality which was monitored/assessed for up to 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place