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Vaccine Therapy and Pembrolizumab in Treating Patients With Hormone-Resistant, Metastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02499835
Recruitment Status : Active, not recruiting
First Posted : July 16, 2015
Results First Posted : December 1, 2022
Last Update Posted : December 1, 2022
Sponsor:
Collaborators:
Prostate Cancer Foundation
Madison Vaccines, Inc
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hormone-Resistant Prostate Cancer
Metastatic Malignant Neoplasm in the Bone
Metastatic Malignant Neoplasm in the Soft Tissues
Metastatic Prostate Carcinoma
Prostate Adenocarcinoma
Recurrent Prostate Carcinoma
Stage IV Prostate Cancer
Interventions Biological: Pembrolizumab
Biological: pTVG-HP Plasmid DNA Vaccine
Enrollment 66
Recruitment Details Participants were enrolled from UW Hospital and Clinics from July 2015 to September 2020
Pre-assignment Details  
Arm/Group Title Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV
Hide Arm/Group Description

Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Period Title: Overall Study
Started 13 13 20 20
Completed 10 9 2 4
Not Completed 3 4 18 16
Reason Not Completed
Withdrawal by Subject             1             0             0             1
Physician Decision             0             3             18             7
Adverse Event             0             0             0             1
Disease progression             2             1             0             7
Arm/Group Title Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV Total
Hide Arm/Group Description

Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Total of all reporting groups
Overall Number of Baseline Participants 13 13 20 20 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 20 participants 20 participants 66 participants
40-49 years
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
1
   1.5%
50-59 years
0
   0.0%
3
  23.1%
0
   0.0%
4
  20.0%
7
  10.6%
60-69 years
7
  53.8%
1
   7.7%
8
  40.0%
8
  40.0%
24
  36.4%
70-79 years
5
  38.5%
6
  46.2%
11
  55.0%
7
  35.0%
29
  43.9%
80-89 years
1
   7.7%
3
  23.1%
0
   0.0%
1
   5.0%
5
   7.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 20 participants 20 participants 66 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
13
 100.0%
13
 100.0%
20
 100.0%
20
 100.0%
66
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 20 participants 20 participants 66 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
13
 100.0%
12
  92.3%
20
 100.0%
20
 100.0%
65
  98.5%
Unknown or Not Reported
0
   0.0%
1
   7.7%
0
   0.0%
0
   0.0%
1
   1.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 20 participants 20 participants 66 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
1
   1.5%
White
13
 100.0%
13
 100.0%
20
 100.0%
19
  95.0%
65
  98.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 20 participants 20 participants 66 participants
13 13 20 20 66
1.Primary Outcome
Title Incidence of Adverse Events, Using the National Cancer Common Terminology Criteria, Version 4
Hide Description Toxicities will be summarized by type, as reported in the adverse events section, and total events calculated per arm.
Time Frame Up to 23 months (Up to 12 months after completion of study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV
Hide Arm/Group Description:

Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Overall Number of Participants Analyzed 13 13 20 20
Measure Type: Number
Unit of Measure: Adverse events
117 173 163 225
2.Primary Outcome
Title 6-month Progression Free Survival Rate
Hide Description 6-month progression-free survival rate will be reported for each arm, and for overall combined study. Progression is at least a 20% increase in the sum of diameters of target lesions and a 0.5cm minimum increase, or the appearance of one or more new lesions. In order to evaluate the 6-month progression-free rate as a function of baseline time point (pretreatment or 3-months post treatment), analysis will be conducted using two different baseline values: date of randomization, and 3-months disease assessment. Central tendency is appropriate due to 20% increase and measurements being a mean of growth across time periods.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV Overall Combined Study
Hide Arm/Group Description:

Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Combination of results from all 4 arms of the study
Overall Number of Participants Analyzed 13 13 20 20 66
Mean (95% Confidence Interval)
Unit of Measure: percent probability
31
(4 to 58)
45
(16 to 74)
44
(1 to 87)
62
(37 to 87)
47
(23 to 63)
3.Primary Outcome
Title Median Time to Radiographic Progression
Hide Description Median time to radiographic progression will be estimated for each, and for both study arms combined, using Kaplan-Meier method. Log-rank test will be used to perform comparison of time to radiographic progression between study arms. A one-sided 0.10 significance level will be used to conduct the comparison of the 6-month progression-free survival rate and time to radiographic progression between study arms. In order to evaluate the median time to radiographic progression as a function of baseline time point (pretreatment or 3-months post treatment), analysis will be conducted.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV Overall Combined Study
Hide Arm/Group Description:

Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Combination of results from all 4 arms of the study
Overall Number of Participants Analyzed 13 13 20 20 66
Median (95% Confidence Interval)
Unit of Measure: months
5.3
(2.6 to 5.4)
5.6
(5.0 to 11.3)
5.6
(4.6 to 12)
8.1
(5.3 to 10.8)
5.6
(5.4 to 10.8)
4.Primary Outcome
Title Number of Participants Who Have an Objective Response
Hide Description Will be calculated for each study arm and for all arms combined. Complete response is the disappearance of all target lesions. Partial response is at least 30% decrease in the sum of diameters of target lesions.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only 25 of the 66 participants had measurable disease. These numbers reflect the number of participants with measurable disease per arm, and the number reported below reflect how many participants with measurable disease had an objective response rate.
Arm/Group Title Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV Overall Study Combined
Hide Arm/Group Description:

Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Combination of results from all 4 arms of the study
Overall Number of Participants Analyzed 6 3 11 5 25
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
1
   4.0%
5.Primary Outcome
Title Number of Participants Who Have a PSA Response
Hide Description Will be calculated for each study arm and for all arms combined. PSA complete response is a decrease in PSA to ,0.2 ng/mL; partial response is greater than or equal to 50% reduction in baseline PSA.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV Overall Combined Study
Hide Arm/Group Description:

Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Combination of results from all 4 arms of the study
Overall Number of Participants Analyzed 13 13 20 20 66
Measure Type: Count of Participants
Unit of Measure: Participants
Any PSA decline
8
  61.5%
1
   7.7%
6
  30.0%
8
  40.0%
23
  34.8%
PSA decline >50%
2
  15.4%
0
   0.0%
2
  10.0%
2
  10.0%
6
   9.1%
6.Secondary Outcome
Title PAP-specific Immune Response
Hide Description Number of PAP-specific immune responses will be summarized in tabular format for each study arm and all study arms combined. A significant antigen-specific response resulting from immunization will be defined as a PAP specific response.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV Overall Combined Study
Hide Arm/Group Description:

Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Combination of results from all 4 arms of the study
Overall Number of Participants Analyzed 13 13 20 20 66
Measure Type: Count of Participants
Unit of Measure: Participants
4
  30.8%
5
  38.5%
2
  10.0%
6
  30.0%
17
  25.8%
7.Secondary Outcome
Title PAP-specific T-cell Response
Hide Description Number and frequencies of PAP-specific T-cell responses will be summarized in tabular format.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV
Hide Arm/Group Description:

Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Overall Number of Participants Analyzed 13 13 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
4
  30.8%
5
  38.5%
2
  10.0%
6
  30.0%
8.Secondary Outcome
Title PD-1 Expression
Hide Description PD-1 and PD-L1 expression levels will be summarized in terms of means, standard deviations and ranges for each study arm separately and for both arms combined. A linear regression model or a negative binomial regression model will be utilized to evaluate effects of schedule (concurrent versus delayed administration pembrolizumab) on PD-1 expression on number of circulating T cells, and PD-L1 expression on number of circulating epithelial cells. Choice of the model will be dependent on distribution of outcome variables (number of circulating T-cells and number of circulating epithelial cells).
Time Frame Up to day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected because of insufficient sample size; therefore, this analysis was not performed
Arm/Group Title Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV
Hide Arm/Group Description:

Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title PD-L1 Expression
Hide Description PD-1 and PD-L1 expression levels will be summarized in terms of means, standard deviations and ranges for each study arm separately and for both arms combined. A linear regression model or a negative binomial regression model will be utilized to evaluate effects of schedule (concurrent versus delayed administration pembrolizumab) on PD-1 expression on number of circulating T cells, and PD-L1 expression on number of circulating epithelial cells. Choice of the model will be dependent on distribution of outcome variables (number of circulating T-cells and number of circulating epithelial cells).
Time Frame Up to day 85
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Hide Analysis Population Description
Data was not collected due to insufficient sample size; therefoe, this analysis was not performed
Arm/Group Title Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV
Hide Arm/Group Description:

Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From time of informed consent up to 23 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV
Hide Arm/Group Description

Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination

Pembrolizumab: Given IV

pTVG-HP Plasmid DNA Vaccine: Given ID

All-Cause Mortality
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/13 (100.00%)      9/13 (69.23%)      16/20 (80.00%)      9/20 (45.00%)    
Hide Serious Adverse Events
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      7/13 (53.85%)      4/20 (20.00%)      3/20 (15.00%)    
Cardiac disorders         
Myocardial infarction  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Cardiac disorders - Other, specify  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Endocrine disorders         
Adrenal insufficiency  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Hyperthyroidism  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Gastrointestinal disorders         
Diarrhea  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Pancreatitis  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Colitis  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Hepatobiliary disorders         
Hepatobiliary disorders - Other, specify  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Immune system disorders         
Autoimmune disorder  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders         
Back pain  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Nervous system disorders         
Stroke  1  1/13 (7.69%)  1 0/13 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders - Other, specify  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Renal and urinary disorders         
Acute kidney injury  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Urinary tract obstruction  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Pneumonitis  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Dyspnea  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Vascular disorders         
Thromboembolic event  1  0/13 (0.00%)  0 2/13 (15.38%)  2 0/20 (0.00%)  0 0/20 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (pTVG-HP Plasmid DNA Vaccine, Concurrent Pembrolizumab) Arm II (pTVG-HP Plasmid DNA Vaccine, Sequential Pembrolizumab) Extended Treatment Arm III Extended Treatment Arm IV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/13 (92.31%)      13/13 (100.00%)      19/20 (95.00%)      19/20 (95.00%)    
Blood and lymphatic system disorders         
Anemia  1  2/13 (15.38%)  2 3/13 (23.08%)  6 0/20 (0.00%)  0 2/20 (10.00%)  2
Blood and lymphatic system disorders - Other, specify  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Cardiac disorders         
Cardiac disorders - Other, specify  1  0/13 (0.00%)  0 1/13 (7.69%)  3 0/20 (0.00%)  0 1/20 (5.00%)  1
Sinus bradycardia  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Myocardial infarction  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Palpitations  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Sinus tachycardia  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Endocrine disorders         
Hyperthyroidism  1  5/13 (38.46%)  6 3/13 (23.08%)  3 0/20 (0.00%)  0 5/20 (25.00%)  8
Hypothyroidism  1  5/13 (38.46%)  6 3/13 (23.08%)  3 0/20 (0.00%)  0 4/20 (20.00%)  4
Endocrine disorders - Other, specify  1  3/13 (23.08%)  5 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Adrenal insufficiency  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Eye disorders         
Eye disorders - Other, specify  1  1/13 (7.69%)  1 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Floaters  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Glaucoma  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Vitreous hemorrhage  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Gastrointestinal disorders         
Diarrhea  1  3/13 (23.08%)  4 5/13 (38.46%)  10 7/20 (35.00%)  11 18/20 (90.00%)  28
Nausea  1  2/13 (15.38%)  2 4/13 (30.77%)  4 4/20 (20.00%)  5 16/20 (80.00%)  18
Constipation  1  1/13 (7.69%)  2 2/13 (15.38%)  2 5/20 (25.00%)  5 12/20 (60.00%)  13
Dry mouth  1  2/13 (15.38%)  2 3/13 (23.08%)  3 1/20 (5.00%)  1 7/20 (35.00%)  7
Vomiting  1  1/13 (7.69%)  1 3/13 (23.08%)  3 3/20 (15.00%)  4 7/20 (35.00%)  8
Abdominal pain  1  0/13 (0.00%)  0 1/13 (7.69%)  1 2/20 (10.00%)  5 4/20 (20.00%)  7
Colitis  1  1/13 (7.69%)  1 1/13 (7.69%)  1 2/20 (10.00%)  2 4/20 (20.00%)  4
Gastritis  1  0/13 (0.00%)  0 1/13 (7.69%)  1 1/20 (5.00%)  1 2/20 (10.00%)  2
Gastroesophageal reflux disease  1  0/13 (0.00%)  0 2/13 (15.38%)  2 0/20 (0.00%)  0 2/20 (10.00%)  2
Anal hemorrhage  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Bloating  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1
Mucositis oral  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1
Pancreatitis  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Rectal hemorrhage  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
General disorders         
Fatigue  1  6/13 (46.15%)  7 6/13 (46.15%)  8 0/20 (0.00%)  0 12/20 (60.00%)  16
Injection site reaction  1  5/13 (38.46%)  20 2/13 (15.38%)  3 0/20 (0.00%)  0 4/20 (20.00%)  18
Chills  1  3/13 (23.08%)  3 1/13 (7.69%)  3 0/20 (0.00%)  0 5/20 (25.00%)  8
Pain  1  1/13 (7.69%)  1 2/13 (15.38%)  2 0/20 (0.00%)  0 2/20 (10.00%)  3
Edema limbs  1  0/13 (0.00%)  0 2/13 (15.38%)  2 0/20 (0.00%)  0 1/20 (5.00%)  1
Flu like symptoms  1  1/13 (7.69%)  1 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  2
Infusion related reaction  1  1/13 (7.69%)  1 0/13 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  5
Malaise  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Non-cardiac chest pain  1  1/13 (7.69%)  1 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Fever  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
General disorders and administration site conditions - Other, specify  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  5
Irritability  1  1/13 (7.69%)  1 0/13 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Multi-organ failure  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Immune system disorders         
Immune system disorders - Other, specify  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Infections and infestations         
Lung infection  1  2/13 (15.38%)  2 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Infections and infestations - Other, specify  1  0/13 (0.00%)  0 2/13 (15.38%)  2 0/20 (0.00%)  0 0/20 (0.00%)  0
Upper respiratory infection  1  1/13 (7.69%)  1 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Bladder infection  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Bronchial infection  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Lip infection  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Rhinitis infective  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Sinusitis  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Tooth infection  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Urinary tract infection  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Injury, poisoning and procedural complications         
Fall  1  2/13 (15.38%)  2 1/13 (7.69%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Investigations         
Aspartate aminotransferase increased  1  1/13 (7.69%)  3 2/13 (15.38%)  4 0/20 (0.00%)  0 2/20 (10.00%)  2
Weight loss  1  2/13 (15.38%)  3 1/13 (7.69%)  2 0/20 (0.00%)  0 1/20 (5.00%)  1
Alanine aminotransferase increased  1  1/13 (7.69%)  2 2/13 (15.38%)  4 0/20 (0.00%)  0 1/20 (5.00%)  1
Creatinine increased  1  1/13 (7.69%)  1 1/13 (7.69%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Serum amylase increased  1  1/13 (7.69%)  1 1/13 (7.69%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Alkaline phosphatase increased  1  1/13 (7.69%)  1 1/13 (7.69%)  2 0/20 (0.00%)  0 0/20 (0.00%)  0
Cholesterol high  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
INR increased  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Weight gain  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Metabolism and nutrition disorders         
Anorexia  1  4/13 (30.77%)  4 8/13 (61.54%)  8 0/20 (0.00%)  0 2/20 (10.00%)  2
Hypoalbuminemia  1  0/13 (0.00%)  0 2/13 (15.38%)  4 0/20 (0.00%)  0 6/20 (30.00%)  8
Hyperglycemia  1  3/13 (23.08%)  5 2/13 (15.38%)  4 0/20 (0.00%)  0 0/20 (0.00%)  0
Dehydration  1  0/13 (0.00%)  0 4/13 (30.77%)  4 0/20 (0.00%)  0 0/20 (0.00%)  0
Hypercalcemia  1  2/13 (15.38%)  2 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Hypokalemia  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Hyponatremia  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Hypertriglyceridemia  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Metabolism and nutrition disorders - Other, specify  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders         
Back pain  1  6/13 (46.15%)  8 5/13 (38.46%)  8 5/20 (25.00%)  8 18/20 (90.00%)  26
Bone pain  1  3/13 (23.08%)  4 5/13 (38.46%)  6 4/20 (20.00%)  5 15/20 (75.00%)  18
Myalgia  1  1/13 (7.69%)  1 1/13 (7.69%)  3 6/20 (30.00%)  7 10/20 (50.00%)  13
Arthralgia  1  2/13 (15.38%)  4 2/13 (15.38%)  3 3/20 (15.00%)  4 8/20 (40.00%)  12
Pain in extremity  1  1/13 (7.69%)  1 3/13 (23.08%)  3 2/20 (10.00%)  2 8/20 (40.00%)  10
Generalized muscle weakness  1  1/13 (7.69%)  2 3/13 (23.08%)  3 1/20 (5.00%)  1 6/20 (30.00%)  7
Muscle weakness lower limb  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 3/20 (15.00%)  3
Neck pain  1  0/13 (0.00%)  0 1/13 (7.69%)  1 1/20 (5.00%)  1 3/20 (15.00%)  3
Arthritis  1  0/13 (0.00%)  0 0/13 (0.00%)  0 2/20 (10.00%)  2 2/20 (10.00%)  2
Musculoskeletal and connective tissue disorder - Other, specify  1  1/13 (7.69%)  1 1/13 (7.69%)  1 0/20 (0.00%)  0 2/20 (10.00%)  2
Chest wall pain  1  1/13 (7.69%)  1 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Flank pain  1  1/13 (7.69%)  1 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Muscle weakness left-sided  1  0/13 (0.00%)  0 1/13 (7.69%)  2 0/20 (0.00%)  0 1/20 (5.00%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  1/13 (7.69%)  1 0/13 (0.00%)  0 0/20 (0.00%)  0 4/20 (20.00%)  4
Nervous system disorders         
Dizziness  1  4/13 (30.77%)  5 2/13 (15.38%)  2 0/20 (0.00%)  0 2/20 (10.00%)  2
Headache  1  2/13 (15.38%)  2 1/13 (7.69%)  2 0/20 (0.00%)  0 3/20 (15.00%)  4
Dysgeusia  1  0/13 (0.00%)  0 1/13 (7.69%)  1 1/20 (5.00%)  1 0/20 (0.00%)  0
Facial muscle weakness  1  1/13 (7.69%)  1 0/13 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders - Other, specify  1  1/13 (7.69%)  2 0/13 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Peripheral sensory neuropathy  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Stroke  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Syncope  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Tremor  1  1/13 (7.69%)  1 0/13 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Psychiatric disorders         
Anxiety  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Depression  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Insomnia  1  1/13 (7.69%)  1 0/13 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Renal and urinary disorders         
Urinary tract obstruction  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Urinary retention  1  1/13 (7.69%)  1 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Acute kidney injury  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Bladder spasm  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Hematuria  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  2 0/20 (0.00%)  0
Renal and urinary disorders - Other, specify  1  1/13 (7.69%)  2 0/13 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Reproductive system and breast disorders         
Pelvic pain  1  1/13 (7.69%)  1 0/13 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Scrotal pain  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  2/13 (15.38%)  2 2/13 (15.38%)  2 0/20 (0.00%)  0 1/20 (5.00%)  1
Dyspnea  1  2/13 (15.38%)  3 3/13 (23.08%)  3 0/20 (0.00%)  0 2/20 (10.00%)  2
Nasal congestion  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 3/20 (15.00%)  4
Pneumonitis  1  2/13 (15.38%)  2 0/13 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Epistaxis  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Hypoxia  1  1/13 (7.69%)  1 0/13 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Sore throat  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Voice alteration  1  0/13 (0.00%)  0 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Wheezing  1  0/13 (0.00%)  0 0/13 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders         
Rash maculo-papular  1  3/13 (23.08%)  4 0/13 (0.00%)  0 0/20 (0.00%)  0 3/20 (15.00%)  7
Skin and subcutaneous tissue disorders - Other, specify  1  2/13 (15.38%)  3 1/13 (7.69%)  1 0/20 (0.00%)  0 2/20 (10.00%)  2
Pruritus  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  4
Dry skin  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Erythema multiforme  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Surgical and medical procedures         
Surgical and medical procedures - Other, specify  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Vascular disorders         
Hypertension  1  4/13 (30.77%)  9 2/13 (15.38%)  2 0/20 (0.00%)  0 5/20 (25.00%)  5
Hot flashes  1  0/13 (0.00%)  0 0/13 (0.00%)  0 0/20 (0.00%)  0 3/20 (15.00%)  3
Hypotension  1  1/13 (7.69%)  1 1/13 (7.69%)  1 0/20 (0.00%)  0 2/20 (10.00%)  4
Hematoma  1  1/13 (7.69%)  1 1/13 (7.69%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Thromboembolic event  1  0/13 (0.00%)  0 2/13 (15.38%)  2 0/20 (0.00%)  0 0/20 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Douglas McNeel, MD
Organization: University of Wisconsin Carbone Cancer Center
Phone: 608-263-4198
EMail: dm3@medicine.wisc.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02499835    
Other Study ID Numbers: UW15014
2015-0453 ( Other Identifier: IRB )
NCI-2015-01154 ( Registry Identifier: NCI CTRP )
A534260 ( Other Identifier: UW Madison )
SMPH\MEDICINE\HEM-ONC ( Other Identifier: UW Madison )
Protocol Version 3/19/2018 ( Other Identifier: UW Madison )
First Submitted: July 14, 2015
First Posted: July 16, 2015
Results First Submitted: July 25, 2022
Results First Posted: December 1, 2022
Last Update Posted: December 1, 2022