Trial Outcomes & Findings for COMbination of Bipolar Androgen Therapy and Nivolumab (NCT NCT03554317)
NCT ID: NCT03554317
Last Updated: 2024-02-20
Results Overview
Number of participants with PSA response to Bipolar Androgen Therapy + Nivolumab. PSA response is counted for participants with ≥ 50% decline in PSA from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
2 years
Results posted on
2024-02-20
Participant Flow
Participant milestones
| Measure |
Bipolar Androgen Therapy + Nivolumab
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.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Bipolar Androgen Therapy + Nivolumab
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
PSA Progression
|
3
|
|
Overall Study
Radiographic Progression
|
4
|
Baseline Characteristics
COMbination of Bipolar Androgen Therapy and Nivolumab
Baseline characteristics by cohort
| Measure |
Bipolar Androgen Therapy + Nivolumab
n=45 Participants
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.
|
|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 Participants
n=5 Participants
|
|
Baseline PSA (ng/mL)
|
57.6 ng/mL
n=5 Participants
|
|
Gleason sum
≤ 7
|
11 Participants
n=5 Participants
|
|
Gleason sum
8
|
8 Participants
n=5 Participants
|
|
Gleason sum
9
|
18 Participants
n=5 Participants
|
|
Gleason sum
10
|
5 Participants
n=5 Participants
|
|
Gleason sum
Unknown
|
3 Participants
n=5 Participants
|
|
Visceral disease
Yes
|
7 Participants
n=5 Participants
|
|
Visceral disease
No
|
38 Participants
n=5 Participants
|
|
Lines of Prior Novel AR (androgen receptor) Targeted Therapy
1
|
21 Participants
n=5 Participants
|
|
Lines of Prior Novel AR (androgen receptor) Targeted Therapy
≥2
|
24 Participants
n=5 Participants
|
|
Prior Taxane Chemotherapy
Yes
|
20 Participants
n=5 Participants
|
|
Prior Taxane Chemotherapy
No
|
25 Participants
n=5 Participants
|
|
≥2 Novel AR (Androgen Receptor) Targeted Therapy and Prior Taxane Chemotherapy
Yes
|
15 Participants
n=5 Participants
|
|
≥2 Novel AR (Androgen Receptor) Targeted Therapy and Prior Taxane Chemotherapy
No
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsNumber of participants with PSA response to Bipolar Androgen Therapy + Nivolumab. PSA response is counted for participants with ≥ 50% decline in PSA from baseline.
Outcome measures
| Measure |
Bipolar Androgen Therapy + Nivolumab
n=45 Participants
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.
|
|---|---|
|
Prostate Specific Antigen (PSA) Response to Bipolar Androgen Therapy + Nivolumab
|
18 Participants
|
SECONDARY outcome
Timeframe: 2 yearsNumber of participants that experience adverse events grade ≥ 3, as defined by Common Terminology Criteria for Adverse Events (CTCAE).
Outcome measures
| Measure |
Bipolar Androgen Therapy + Nivolumab
n=45 Participants
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.
|
|---|---|
|
Safety of Bipolar Androgen Therapy + Nivolumab As Determined by the Number of CTCAEs ≥ Grade 3
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 yearsNumber 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.
Outcome measures
| Measure |
Bipolar Androgen Therapy + Nivolumab
n=45 Participants
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.
|
|---|---|
|
PSA Progression-Free Survival (PSA-PFS) to Bipolar Androgen Therapy + Nivolumab
|
4.0 months
Interval 3.6 to 5.0
|
SECONDARY outcome
Timeframe: 2 yearsMedian 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.
Outcome measures
| Measure |
Bipolar Androgen Therapy + Nivolumab
n=45 Participants
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.
|
|---|---|
|
Progression-Free Survival (PFS) to Bipolar Androgen Therapy + Nivolumab
|
5.6 months
Interval 5.4 to 6.8
|
SECONDARY outcome
Timeframe: 2 yearsPercentage of patients achieving a complete or partial response in target lesions as defined by RECIST 1.1 Criteria.
Outcome measures
| Measure |
Bipolar Androgen Therapy + Nivolumab
n=45 Participants
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.
|
|---|---|
|
Objective Response Rate (ORR) to Bipolar Androgen Therapy + Nivolumab
|
18 percentage of overall participants
|
SECONDARY outcome
Timeframe: 2 yearsNumber of participants without clinical/radiographic progression for \> 6 months from the start of treatment.
Outcome measures
| Measure |
Bipolar Androgen Therapy + Nivolumab
n=45 Participants
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.
|
|---|---|
|
Durable Progression-Free Survival (Durable PFS) to Bipolar Androgen Therapy + Nivolumab
|
15 Participants
|
SECONDARY outcome
Timeframe: 3 yearsMedian number of months from study enrollment to death from any cause up to 2 years after the last dose of study treatment received.
Outcome measures
| Measure |
Bipolar Androgen Therapy + Nivolumab
n=45 Participants
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.
|
|---|---|
|
Median Overall Survival (OS) to Bipolar Androgen Therapy + Nivolumab
|
24.4 months
Interval 17.6 to 31.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsNumber 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsNumber 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsClinical 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsClinical 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 years.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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 years.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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 years.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.
Outcome measures
Outcome data not reported
Adverse Events
Bipolar Androgen Therapy + Nivolumab
Serious events: 11 serious events
Other events: 45 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Bipolar Androgen Therapy + Nivolumab
n=45 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
General disorders
Fever
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Vascular disorders
Hypertension
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Investigations
Investigations - Other, abnormal ECG
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.2%
1/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
General disorders
Pain in extremity
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Cardiac disorders
Pericardial effusion
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Cardiac disorders
Pericarditis
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
1/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Rectal fistula
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, left-sided renal obstruction
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Urinary tract infection
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Vascular disorders
Vascular disorders - Other, deep vein thrombosis
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Blood and lymphatic system disorders
Blood lactate dehydrogenase increased
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
Other adverse events
| Measure |
Bipolar Androgen Therapy + Nivolumab
n=45 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Bloating
|
2.2%
1/45 • Number of events 45 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
6/45 • Number of events 6 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, acute hypoxic respiratory failure
|
2.2%
1/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
8.9%
4/45 • Number of events 4 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Investigations
Serum amylase increased
|
6.7%
3/45 • Number of events 4 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
2.2%
1/45 • Number of events 4 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
General disorders
Edema limbs
|
24.4%
11/45 • Number of events 15 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
4/45 • Number of events 8 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
5/45 • Number of events 5 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
31.1%
14/45 • Number of events 24 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Investigations
Blood bilirubin increased
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Eye disorders
Blurry vision
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Colitis
|
4.4%
2/45 • Number of events 3 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
22.2%
10/45 • Number of events 10 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
6/45 • Number of events 6 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Investigations
CPK increased
|
8.9%
4/45 • Number of events 5 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Investigations
Creatinine increased
|
15.6%
7/45 • Number of events 8 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Psychiatric disorders
Depression
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
9/45 • Number of events 11 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Psychiatric disorders
Dizziness
|
6.7%
3/45 • Number of events 3 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Vascular disorders
Vascular disorders - Other, deep vein thrombosis
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Nervous system disorders
Dysgeusia
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Dyspnea
|
13.3%
6/45 • Number of events 6 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
General disorders
Edema face
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Eye disorders
Conjunctivitis
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Eye disorders
Eye disorders - other, double vision
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Vascular disorders
Flushing
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
General disorders
Fatigue
|
22.2%
10/45 • Number of events 13 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
General disorders
Fever
|
4.4%
2/45 • Number of events 3 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
General disorders
Flu like symptoms
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.2%
1/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Reproductive system and breast disorders
Genital edema
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Nervous system disorders
Headache
|
6.7%
3/45 • Number of events 3 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
8.9%
4/45 • Number of events 4 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Vascular disorders
Hot flashes
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, hydrocalycosis
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemai
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Vascular disorders
Hypertension
|
6.7%
3/45 • Number of events 4 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Endocrine disorders
Hyperthyroidism
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.2%
1/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.2%
1/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Vascular disorders
Hypotension
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Endocrine disorders
Hypothyroidism
|
11.1%
5/45 • Number of events 5 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Ileus
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Psychiatric disorders
Insomnia
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Investigations
Investigations - Other, elevated white blood cells
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Psychiatric disorders
Irritability
|
11.1%
5/45 • Number of events 5 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Kidney infection
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Investigations
Lipase increased
|
8.9%
4/45 • Number of events 8 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
General disorders
Localized edema
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
2.2%
1/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, macular rash
|
6.7%
3/45 • Number of events 3 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - other, restless legs
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.9%
4/45 • Number of events 5 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.9%
4/45 • Number of events 5 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
40.0%
18/45 • Number of events 19 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
General disorders
Non-cardiac chest pain
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
General disorders
Pain
|
13.3%
6/45 • Number of events 13 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
General disorders
Pain in extremity
|
31.1%
14/45 • Number of events 23 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumontiis
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
3/45 • Number of events 3 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.4%
2/45 • Number of events 3 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Rectal fistula
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Rectal pain
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, urinary dysfunction
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Infections and infestations
Sinusitis
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, pruritic rash
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, follicular rash
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, desquamation
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Nervous system disorders
Spinal cord compression
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Reproductive system and breast disorders
Testicular disorder
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Infections and infestations
Thrush
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Infections and infestations
Tooth infection
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Nervous system disorders
Tremor
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
3/45 • Number of events 3 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
3/45 • Number of events 4 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
3/45 • Number of events 3 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Urinary tract infection
|
2.2%
1/45 • Number of events 5 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Renal and urinary disorders
Urinary urgency
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Eye disorders
Uveitis
|
2.2%
1/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
15.6%
7/45 • Number of events 9 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
3/45 • Number of events 4 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Reproductive system and breast disorders
Breast pain
|
6.7%
3/45 • Number of events 3 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
General disorders
Facial pain
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
3/45 • Number of events 3 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
General disorders
Injection site reaction
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Cardiac disorders
Myocardial infarction
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Nervous system disorders
Paresthesia
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Investigations
Platelet count decreased
|
4.4%
2/45 • Number of events 2 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
1/45 • Number of events 1 • Adverse events were assessed up to 2 years. All-Cause Mortality was assessed up to 3 years
|
Additional Information
Dr. Mark Markowski
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Phone: 410-614-0567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER