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COMbination of Bipolar Androgen Therapy and Nivolumab (COMBAT-CRPC)

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ClinicalTrials.gov Identifier: NCT03554317
Recruitment Status : Completed
First Posted : June 13, 2018
Results First Posted : October 3, 2023
Last Update Posted : February 20, 2024
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Castration-resistant Prostate Cancer
Metastatic Prostate Cancer
Prostate Cancer
Interventions Drug: Testosterone cypionate
Drug: Nivolumab
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bipolar Androgen Therapy + Nivolumab
Hide Arm/Group Description All participants must have a rising PSA and/or radiographic progression and prior treatment with at least one novel androgen receptor (AR) targeted therapy (i.e. abiraterone acetate, enzalutamide). Up to one taxane agent for metastatic castration-resistant prostate cancer is permitted. Patients will be treated with testosterone cypionate 400mg IM every 4 weeks for a lead-in period of 12 weeks. After the lead-in period, all patients will be treated with nivolumab 480mg IV every 4 weeks and maintained on testosterone cypionate 400mg intramuscular (IM) every 4 weeks. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA progression (PCGW3 criteria) or clinical/radiographic progression (whichever comes first), or until unmanageable toxicity requiring drug cessation.
Period Title: Overall Study
Started 45
Completed 37
Not Completed 8
Reason Not Completed
Withdrawal by Subject             1
PSA Progression             3
Radiographic Progression             4
Arm/Group Title Bipolar Androgen Therapy + Nivolumab
Hide Arm/Group Description All participants must have a rising PSA and/or radiographic progression and prior treatment with at least one novel androgen receptor (AR) targeted therapy (i.e. abiraterone acetate, enzalutamide). Up to one taxane agent for metastatic castration-resistant prostate cancer is permitted. Patients will be treated with testosterone cypionate 400mg IM every 4 weeks for a lead-in period of 12 weeks. After the lead-in period, all patients will be treated with nivolumab 480mg IV every 4 weeks and maintained on testosterone cypionate 400mg IM every 4 weeks. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA progression (PCGW3 criteria) or clinical/radiographic progression (whichever comes first), or until unmanageable toxicity requiring drug cessation.
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants
69
(51 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
0
   0.0%
Male
45
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   8.9%
White
40
  88.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
 100.0%
Baseline PSA (ng/mL)   [1] 
Median (Full Range)
Unit of measure:  ng/mL
Number Analyzed 45 participants
57.6
(5.4 to 457)
[1]
Measure Description: Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in the blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood.
Gleason sum   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
≤ 7
11
  24.4%
8
8
  17.8%
9
18
  40.0%
10
5
  11.1%
Unknown
3
   6.7%
[1]
Measure Description: For most prostate cancers, the Gleason sum ranges from 6 to 10. Gleason 6 is the least aggressive cancer type. Gleason 7 is intermediately aggressive. Gleason 8-10 is the most aggressive cancer type.
Visceral disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Yes
7
  15.6%
No
38
  84.4%
[1]
Measure Description: Visceral disease is described as the presence of soft tissue lesions.
Lines of Prior Novel AR (androgen receptor) Targeted Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
1
21
  46.7%
≥2
24
  53.3%
Prior Taxane Chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Yes
20
  44.4%
No
25
  55.6%
≥2 Novel AR (Androgen Receptor) Targeted Therapy and Prior Taxane Chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Yes
15
  33.3%
No
30
  66.7%
1.Primary Outcome
Title Prostate Specific Antigen (PSA) Response to Bipolar Androgen Therapy + Nivolumab
Hide Description Number of participants with PSA response to Bipolar Androgen Therapy + Nivolumab. PSA response is counted for participants with ≥ 50% decline in PSA from baseline.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bipolar Androgen Therapy + Nivolumab
Hide Arm/Group Description:
All participants must have a rising PSA and/or radiographic progression and prior treatment with at least one novel androgen receptor (AR) targeted therapy (i.e. abiraterone acetate, enzalutamide). Up to one taxane agent for metastatic castration-resistant prostate cancer is permitted. Patients will be treated with testosterone cypionate 400mg IM every 4 weeks for a lead-in period of 12 weeks. After the lead-in period, all patients will be treated with nivolumab 480mg IV every 4 weeks and maintained on testosterone cypionate 400mg IM every 4 weeks. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA progression (PCGW3 criteria) or clinical/radiographic progression (whichever comes first), or until unmanageable toxicity requiring drug cessation.
Overall Number of Participants Analyzed 45
Measure Type: Count of Participants
Unit of Measure: Participants
18
  40.0%
2.Secondary Outcome
Title Safety of Bipolar Androgen Therapy + Nivolumab As Determined by the Number of CTCAEs ≥ Grade 3
Hide Description Number of participants that experience adverse events grade ≥ 3, as defined by Common Terminology Criteria for Adverse Events (CTCAE).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bipolar Androgen Therapy + Nivolumab
Hide Arm/Group Description:
All participants must have a rising PSA and/or radiographic progression and prior treatment with at least one novel androgen receptor (AR) targeted therapy (i.e. abiraterone acetate, enzalutamide). Up to one taxane agent for metastatic castration-resistant prostate cancer is permitted. Patients will be treated with testosterone cypionate 400mg IM every 4 weeks for a lead-in period of 12 weeks. After the lead-in period, all patients will be treated with nivolumab 480mg IV every 4 weeks and maintained on testosterone cypionate 400mg IM every 4 weeks. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA progression (PCGW3 criteria) or clinical/radiographic progression (whichever comes first), or until unmanageable toxicity requiring drug cessation.
Overall Number of Participants Analyzed 45
Measure Type: Count of Participants
Unit of Measure: Participants
5
  11.1%
3.Secondary Outcome
Title PSA Progression-Free Survival (PSA-PFS) to Bipolar Androgen Therapy + Nivolumab
Hide Description Number of months from the time of initiation on Bipolar Androgen Therapy + Nivolumab therapy until PSA increase of 25% over a nadir value, confirmed by a follow-up PSA at least 4 weeks apart.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bipolar Androgen Therapy + Nivolumab
Hide Arm/Group Description:
All participants must have a rising PSA and/or radiographic progression and prior treatment with at least one novel androgen receptor (AR) targeted therapy (i.e. abiraterone acetate, enzalutamide). Up to one taxane agent for metastatic castration-resistant prostate cancer is permitted. Patients will be treated with testosterone cypionate 400mg IM every 4 weeks for a lead-in period of 12 weeks. After the lead-in period, all patients will be treated with nivolumab 480mg IV every 4 weeks and maintained on testosterone cypionate 400mg IM every 4 weeks. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA progression (PCGW3 criteria) or clinical/radiographic progression (whichever comes first), or until unmanageable toxicity requiring drug cessation.
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: months
4.0
(3.6 to 5.0)
4.Secondary Outcome
Title Progression-Free Survival (PFS) to Bipolar Androgen Therapy + Nivolumab
Hide Description Median number of months from the time of the first dose to objective radiographic tumor progression or death, whichever comes first, as defined by RECIST 1.1 Criteria for progressive disease or death.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bipolar Androgen Therapy + Nivolumab
Hide Arm/Group Description:
All participants must have a rising PSA and/or radiographic progression and prior treatment with at least one novel androgen receptor (AR) targeted therapy (i.e. abiraterone acetate, enzalutamide). Up to one taxane agent for metastatic castration-resistant prostate cancer is permitted. Patients will be treated with testosterone cypionate 400mg IM every 4 weeks for a lead-in period of 12 weeks. After the lead-in period, all patients will be treated with nivolumab 480mg IV every 4 weeks and maintained on testosterone cypionate 400mg IM every 4 weeks. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA progression (PCGW3 criteria) or clinical/radiographic progression (whichever comes first), or until unmanageable toxicity requiring drug cessation.
Overall Number of Participants Analyzed 45
Median (95% Confidence Interval)
Unit of Measure: months
5.6
(5.4 to 6.8)
5.Secondary Outcome
Title Objective Response Rate (ORR) to Bipolar Androgen Therapy + Nivolumab
Hide Description Percentage of patients achieving a complete or partial response in target lesions as defined by RECIST 1.1 Criteria.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bipolar Androgen Therapy + Nivolumab
Hide Arm/Group Description:
All participants must have a rising PSA and/or radiographic progression and prior treatment with at least one novel androgen receptor (AR) targeted therapy (i.e. abiraterone acetate, enzalutamide). Up to one taxane agent for metastatic castration-resistant prostate cancer is permitted. Patients will be treated with testosterone cypionate 400mg IM every 4 weeks for a lead-in period of 12 weeks. After the lead-in period, all patients will be treated with nivolumab 480mg IV every 4 weeks and maintained on testosterone cypionate 400mg IM every 4 weeks. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA progression (PCGW3 criteria) or clinical/radiographic progression (whichever comes first), or until unmanageable toxicity requiring drug cessation.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: percentage of overall participants
18
6.Secondary Outcome
Title Durable Progression-Free Survival (Durable PFS) to Bipolar Androgen Therapy + Nivolumab
Hide Description Number of participants without clinical/radiographic progression for > 6 months from the start of treatment.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bipolar Androgen Therapy + Nivolumab
Hide Arm/Group Description:
All participants must have a rising PSA and/or radiographic progression and prior treatment with at least one novel androgen receptor (AR) targeted therapy (i.e. abiraterone acetate, enzalutamide). Up to one taxane agent for metastatic castration-resistant prostate cancer is permitted. Patients will be treated with testosterone cypionate 400mg IM every 4 weeks for a lead-in period of 12 weeks. After the lead-in period, all patients will be treated with nivolumab 480mg IV every 4 weeks and maintained on testosterone cypionate 400mg IM every 4 weeks. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA progression (PCGW3 criteria) or clinical/radiographic progression (whichever comes first), or until unmanageable toxicity requiring drug cessation.
Overall Number of Participants Analyzed 45
Measure Type: Count of Participants
Unit of Measure: Participants
15
  33.3%
7.Secondary Outcome
Title Median Overall Survival (OS) to Bipolar Androgen Therapy + Nivolumab
Hide Description Median number of months from study enrollment to death from any cause up to 2 years after the last dose of study treatment received.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bipolar Androgen Therapy + Nivolumab
Hide Arm/Group Description:
All participants must have a rising PSA and/or radiographic progression and prior treatment with at least one novel androgen receptor (AR) targeted therapy (i.e. abiraterone acetate, enzalutamide). Up to one taxane agent for metastatic castration-resistant prostate cancer is permitted. Patients will be treated with testosterone cypionate 400mg IM every 4 weeks for a lead-in period of 12 weeks. After the lead-in period, all patients will be treated with nivolumab 480mg IV every 4 weeks and maintained on testosterone cypionate 400mg IM every 4 weeks. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA progression (PCGW3 criteria) or clinical/radiographic progression (whichever comes first), or until unmanageable toxicity requiring drug cessation.
Overall Number of Participants Analyzed 45
Median (95% Confidence Interval)
Unit of Measure: months
24.4
(17.6 to 31.1)
8.Other Pre-specified Outcome
Title PSA Response to Bipolar Androgen Therapy + Nivolumab in Patients With Gene Mutations
Hide Description Number of patients with ≥ 50% decline in PSA from baseline in patients with a somatic or germline mutation in homologous repair (HR) and/or mismatch repair (MMR) genes.
Time Frame 2 years
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title PSA Response to Bipolar Androgen Therapy + Nivolumab in Patients Without Gene Mutations
Hide Description Number of patients with ≥ 50% decline in PSA from baseline in patients without a somatic or germline mutation in homologous repair (HR) and/or mismatch repair (MMR) genes.
Time Frame 2 years
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Clinical Response Association of Bipolar Androgen Therapy + Nivolumab to Mutation-associated Neoantigens (MANAs).
Hide Description Clinical Response Association of Bipolar Androgen Therapy + Nivolumab to mutation-associated neoantigens (MANAs) can be assessed by the number of patients treated with Bipolar Androgen Therapy + Nivolumab with the presence of MANAs.
Time Frame 3 years
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Clinical Response Association to Bipolar Androgen Therapy + Nivolumab as Assessed by the Generation of Tumor-associated Neoantigens (TAAs)
Hide Description Clinical Response Association to Bipolar Androgen Therapy + Nivolumab with generation of tumor-associated neoantigens (TAAs) can be assessed by the number of patients treated with Bipolar Androgen Therapy + Nivolumab that have TAAs.
Time Frame 3 years
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title PSA Correlation With Immune Markers in Response to Bipolar Androgen Therapy + Nivolumab
Hide Description Immunohistochemistry (IHC) staining will be used to quantify the number of immune markers present in pre-treatment and on-treatment biopsies in responders whose PSA has declined ≥ 50% versus non-responders.
Time Frame 2 years.
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title PSA Correlation With DNA Damage Markers in Response to Bipolar Androgen Therapy + Nivolumab
Hide Description Immunohistochemistry (IHC) staining will be used to quantify the number of DNA damage markers present in pre-treatment and on-treatment biopsies in responders whose PSA has declined ≥ 50% versus non-responders.
Time Frame 2 years.
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Correlation of Bipolar Androgen Therapy on the Production of Inflammatory Chemokines and Cytokines
Hide Description Milliplex human cytokine/chemokine Immunology Multiplex Assay (Millipore-Sigma) will be used to assay acute effects of Bipolar Androgen Therapy by detecting the amount of cytokines and chemokines produced during therapy.
Time Frame 2 years.
Outcome Measure Data Not Reported
Time Frame Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bipolar Androgen Therapy + Nivolumab
Hide Arm/Group Description All participants must have a rising PSA and/or radiographic progression and prior treatment with at least one novel androgen receptor (AR) targeted therapy (i.e. abiraterone acetate, enzalutamide). Up to one taxane agent for metastatic castration-resistant prostate cancer is permitted. Patients will be treated with testosterone cypionate 400mg IM every 4 weeks for a lead-in period of 12 weeks. After the lead-in period, all patients will be treated with nivolumab 480mg IV every 4 weeks and maintained on testosterone cypionate 400mg IM every 4 weeks. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA progression (PCGW3 criteria) or clinical/radiographic progression (whichever comes first), or until unmanageable toxicity requiring drug cessation.
All-Cause Mortality
Bipolar Androgen Therapy + Nivolumab
Affected / at Risk (%)
Total   13/45 (28.89%)    
Hide Serious Adverse Events
Bipolar Androgen Therapy + Nivolumab
Affected / at Risk (%) # Events
Total   11/45 (24.44%)    
Blood and lymphatic system disorders   
Leukocytosis *  1/45 (2.22%)  2
Blood lactate dehydrogenase increased *  1/45 (2.22%)  1
Cardiac disorders   
Chest pain - cardiac *  1/45 (2.22%)  1
Pericardial effusion *  1/45 (2.22%)  1
Pericarditis *  1/45 (2.22%)  1
Gastrointestinal disorders   
Abdominal pain *  1/45 (2.22%)  1
Diarrhea *  1/45 (2.22%)  1
Nausea *  2/45 (4.44%)  2
Rectal fistula *  1/45 (2.22%)  1
Vomiting *  1/45 (2.22%)  1
General disorders   
Fever *  2/45 (4.44%)  2
Pain in extremity *  1/45 (2.22%)  1
Investigations   
Investigations - Other, abnormal ECG *  1/45 (2.22%)  1
Metabolism and nutrition disorders   
Hyponatremia *  1/45 (2.22%)  1
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness *  1/45 (2.22%)  1
Renal and urinary disorders   
Acute kidney injury *  1/45 (2.22%)  1
Renal and urinary disorders - Other, left-sided renal obstruction *  1/45 (2.22%)  1
Urinary tract infection *  2/45 (4.44%)  2
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome *  1/45 (2.22%)  1
Lung infection *  1/45 (2.22%)  1
Pleural effusion *  1/45 (2.22%)  2
Pneumonitis *  1/45 (2.22%)  1
Skin and subcutaneous tissue disorders   
Rash maculo-papular *  1/45 (2.22%)  1
Vascular disorders   
Hypertension *  1/45 (2.22%)  1
Vascular disorders - Other, deep vein thrombosis *  1/45 (2.22%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bipolar Androgen Therapy + Nivolumab
Affected / at Risk (%) # Events
Total   45/45 (100.00%)    
Blood and lymphatic system disorders   
Anemia *  1/45 (2.22%)  4
Cardiac disorders   
Atrial fibrillation *  1/45 (2.22%)  1
Chest pain - cardiac *  1/45 (2.22%)  1
Sinus tachycardia *  1/45 (2.22%)  1
Myocardial infarction *  1/45 (2.22%)  1
Ear and labyrinth disorders   
Tinnitus *  1/45 (2.22%)  1
Vertigo *  1/45 (2.22%)  1
Endocrine disorders   
Hyperthyroidism *  1/45 (2.22%)  1
Hypothyroidism *  5/45 (11.11%)  5
Eye disorders   
Blurry vision *  1/45 (2.22%)  1
Conjunctivitis *  1/45 (2.22%)  1
Eye disorders - other, double vision *  1/45 (2.22%)  1
Uveitis *  1/45 (2.22%)  2
Gastrointestinal disorders   
Bloating *  1/45 (2.22%)  45
Abdominal pain *  6/45 (13.33%)  6
Colitis *  2/45 (4.44%)  3
Constipation *  10/45 (22.22%)  10
Diarrhea *  9/45 (20.00%)  11
Dry mouth *  1/45 (2.22%)  1
Dyspepsia *  1/45 (2.22%)  1
Gastritis *  1/45 (2.22%)  1
Gastroesophageal reflux disease *  1/45 (2.22%)  2
Ileus *  1/45 (2.22%)  1
Nausea *  18/45 (40.00%)  19
Rectal fistula *  1/45 (2.22%)  1
Rectal pain *  1/45 (2.22%)  1
Vomiting *  7/45 (15.56%)  9
General disorders   
Edema limbs *  1/45 (2.22%)  1
Edema face *  2/45 (4.44%)  2
Edema limbs *  11/45 (24.44%)  15
Fatigue *  10/45 (22.22%)  13
Fever *  2/45 (4.44%)  3
Flu like symptoms *  1/45 (2.22%)  1
Localized edema *  2/45 (4.44%)  2
Non-cardiac chest pain *  2/45 (4.44%)  2
Pain *  6/45 (13.33%)  13
Pain in extremity *  14/45 (31.11%)  23
Facial pain *  1/45 (2.22%)  1
Injection site reaction *  1/45 (2.22%)  1
Infections and infestations   
Sinusitis *  1/45 (2.22%)  1
Thrush *  1/45 (2.22%)  1
Tooth infection *  1/45 (2.22%)  1
Injury, poisoning and procedural complications   
Fall *  2/45 (4.44%)  2
Investigations   
Alanine aminotransferase increased *  4/45 (8.89%)  4
Alkaline phosphatase increased *  2/45 (4.44%)  2
Serum amylase increased *  1/45 (2.22%)  3
Aspartate aminotransferase increased *  5/45 (11.11%)  5
Blood bilirubin increased *  2/45 (4.44%)  2
CPK increased *  4/45 (8.89%)  5
Creatinine increased *  7/45 (15.56%)  8
Investigations - Other, elevated white blood cells *  1/45 (2.22%)  1
Lipase increased *  4/45 (8.89%)  8
Serum amylase increased *  3/45 (6.67%)  4
Platelet count decreased *  2/45 (4.44%)  2
Metabolism and nutrition disorders   
Anorexia *  3/45 (6.67%)  3
Anorexia *  1/45 (2.22%)  1
Dehydration *  1/45 (2.22%)  1
Hyperglycemai *  1/45 (2.22%)  1
Hyperkalemia *  1/45 (2.22%)  1
Hypokalemia *  1/45 (2.22%)  1
Hyponatremia *  1/45 (2.22%)  2
Hypophosphatemia *  1/45 (2.22%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia *  4/45 (8.89%)  8
Back pain *  14/45 (31.11%)  24
Generalized muscle weakness *  1/45 (2.22%)  1
Musculoskeletal and connective tissue disorders - other, restless legs *  1/45 (2.22%)  1
Myalgia *  4/45 (8.89%)  5
Bone pain *  3/45 (6.67%)  4
Flank pain *  3/45 (6.67%)  3
Nervous system disorders   
Dysgeusia *  2/45 (4.44%)  2
Headache *  3/45 (6.67%)  3
Spinal cord compression *  1/45 (2.22%)  1
Tremor *  1/45 (2.22%)  1
Paresthesia *  1/45 (2.22%)  1
Psychiatric disorders   
Depression *  1/45 (2.22%)  1
Dizziness *  3/45 (6.67%)  3
Insomnia *  1/45 (2.22%)  1
Irritability *  5/45 (11.11%)  5
Renal and urinary disorders   
Dyspnea *  6/45 (13.33%)  6
Hematuria *  4/45 (8.89%)  4
Renal and urinary disorders - Other, hydrocalycosis *  1/45 (2.22%)  1
Kidney infection *  1/45 (2.22%)  1
Renal and urinary disorders - Other, urinary dysfunction *  1/45 (2.22%)  1
Urinary frequency *  3/45 (6.67%)  3
Urinary incontinence *  3/45 (6.67%)  4
Urinary retention *  3/45 (6.67%)  3
Urinary tract infection *  1/45 (2.22%)  5
Urinary tract obstruction *  1/45 (2.22%)  1
Urinary urgency *  1/45 (2.22%)  1
Reproductive system and breast disorders   
Genital edema *  2/45 (4.44%)  2
Testicular disorder *  1/45 (2.22%)  1
Breast pain *  3/45 (6.67%)  3
Respiratory, thoracic and mediastinal disorders   
Respiratory, thoracic and mediastinal disorders - Other, acute hypoxic respiratory failure *  1/45 (2.22%)  2
Allergic rhinitis *  1/45 (2.22%)  1
Cough *  6/45 (13.33%)  6
Epistaxis *  1/45 (2.22%)  1
Lung infection *  1/45 (2.22%)  2
Nasal congestion *  4/45 (8.89%)  5
Pneumontiis *  1/45 (2.22%)  1
Sleep apnea *  2/45 (4.44%)  2
Upper respiratory infection *  1/45 (2.22%)  1
Pleuritic pain *  1/45 (2.22%)  1
Pleural effusion *  1/45 (2.22%)  1
Skin and subcutaneous tissue disorders   
Hypertrichosis *  1/45 (2.22%)  1
Skin and subcutaneous tissue disorders - Other, macular rash *  1/45 (2.22%)  1
Pruritus *  3/45 (6.67%)  3
Rash maculo-papular *  2/45 (4.44%)  3
Skin and subcutaneous tissue disorders - Other, macular rash *  3/45 (6.67%)  3
Skin and subcutaneous tissue disorders - Other, pruritic rash *  1/45 (2.22%)  1
Skin and subcutaneous tissue disorders - Other, follicular rash *  1/45 (2.22%)  1
Skin infection *  1/45 (2.22%)  1
Skin and subcutaneous tissue disorders - Other, desquamation *  1/45 (2.22%)  1
Hyperhidrosis *  1/45 (2.22%)  1
Vascular disorders   
Vascular disorders - Other, deep vein thrombosis *  1/45 (2.22%)  1
Flushing *  2/45 (4.44%)  2
Hot flashes *  1/45 (2.22%)  1
Hypertension *  3/45 (6.67%)  4
Hypotension *  1/45 (2.22%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI may not publish results before Sponsor/Sponsor PI. If no multicenter publication within 12 months from study completion or termination at all sites, PI may publish results as long as Sponsor PI has copy of communication for review and comment at least 30 days before submission. Sponsor may request PI hold communication for additional 65 days to allow for filing of patent application or other methods to preserve proprietary and/or patent rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mark Markowski
Organization: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Phone: 410-614-0567
EMail: mmarko12@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03554317    
Other Study ID Numbers: J1812
IRB00164973 ( Other Identifier: JHM IRB )
First Submitted: May 23, 2018
First Posted: June 13, 2018
Results First Submitted: September 6, 2023
Results First Posted: October 3, 2023
Last Update Posted: February 20, 2024