Trial Outcomes & Findings for Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers (NCT NCT03816332)
NCT ID: NCT03816332
Last Updated: 2026-04-30
Results Overview
Percentage of kidney transplant recipients who experienced complete response (CR), partial response (PR) or stable disease (SD) without allograft loss.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
At 16 weeks
Results posted on
2026-04-30
Participant Flow
Participant milestones
| Measure |
Treatment
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5mg by mouth once a day, and nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity.
Patients who experienced disease progression by the 16-week time point, could receive tacrolimus, prednisone, nivolumab 3 mg/kg IV + ipilimumab 1 mg/kg by infusion every 3 weeks for 4 doses followed by maintenance nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Nivolumab, Tacrolimus, and Prednisone
STARTED
|
12
|
|
Nivolumab, Tacrolimus, and Prednisone
COMPLETED
|
8
|
|
Nivolumab, Tacrolimus, and Prednisone
NOT COMPLETED
|
4
|
|
Nivolumab, Ipilimumab, Tacrolimus, Pred
STARTED
|
6
|
|
Nivolumab, Ipilimumab, Tacrolimus, Pred
COMPLETED
|
6
|
|
Nivolumab, Ipilimumab, Tacrolimus, Pred
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Treatment
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5mg by mouth once a day, and nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity.
Patients who experienced disease progression by the 16-week time point, could receive tacrolimus, prednisone, nivolumab 3 mg/kg IV + ipilimumab 1 mg/kg by infusion every 3 weeks for 4 doses followed by maintenance nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Nivolumab, Tacrolimus, and Prednisone
Did not receive Nivolumab
|
2
|
|
Nivolumab, Tacrolimus, and Prednisone
Death
|
2
|
Baseline Characteristics
Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers
Baseline characteristics by cohort
| Measure |
Treatment (Tacrolimus, Prednisone, Nivolumab, Ipilimumab)
n=12 Participants
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5mg by mouth once a day, and nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity.
Patients who experienced disease progression by the 16-week time point, could receive tacrolimus, prednisone, nivolumab 3 mg/kg IV + ipilimumab 1 mg/kg by infusion every 3 weeks for 4 doses followed by maintenance nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=14 Participants
|
|
Age, Continuous
|
69 years
n=14 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=14 Participants
|
|
Height
|
168.4 centimeter (cm)
n=14 Participants
|
|
Weight
|
68.3 kilogram (kg)
n=14 Participants
|
|
BSA
|
1.74 meters squared (m^2)
n=14 Participants
|
PRIMARY outcome
Timeframe: At 16 weeksPercentage of kidney transplant recipients who experienced complete response (CR), partial response (PR) or stable disease (SD) without allograft loss.
Outcome measures
| Measure |
Nivolumab, Tacrolimus, and Prednisone
n=8 Participants
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5 mg by mouth once a day, and nivolumab 480 mg by infusion over 30 minutes on day 1. Cycles repeated every 4 weeks for up to 24 cycles (96 weeks) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number (and Percentage) of Outcome Responses After Receiving Nivolumab, Tacrolimus, and Prednisone
Complete response (CR), partial response (PR) or stable disease (SD) without allograft loss
|
0 Participants
|
|
Number (and Percentage) of Outcome Responses After Receiving Nivolumab, Tacrolimus, and Prednisone
Progressive Disease (PD) without allograft loss
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 4 monthsNumber (and percentage) of patients with a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria after receiving at least one dose of nivolumab.
Outcome measures
| Measure |
Nivolumab, Tacrolimus, and Prednisone
n=8 Participants
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5 mg by mouth once a day, and nivolumab 480 mg by infusion over 30 minutes on day 1. Cycles repeated every 4 weeks for up to 24 cycles (96 weeks) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Objective Response (CR or PR) Rate (ORR) After Receiving Nivolumab, Tacrolimus, and Prednisone
Complete response (CR) or Partial Response (PR)
|
0 Participants
|
|
Objective Response (CR or PR) Rate (ORR) After Receiving Nivolumab, Tacrolimus, and Prednisone
Progressive Disease (PD)
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 4 monthsNumber of subjects who experienced allograft loss after receiving at least one dose of nivolumab.
Outcome measures
| Measure |
Nivolumab, Tacrolimus, and Prednisone
n=8 Participants
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5 mg by mouth once a day, and nivolumab 480 mg by infusion over 30 minutes on day 1. Cycles repeated every 4 weeks for up to 24 cycles (96 weeks) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Rate of Allograft Loss After Receiving Nivolumab, Tacrolimus, and Prednisone
Experienced allograft loss
|
0 Participants
|
|
Rate of Allograft Loss After Receiving Nivolumab, Tacrolimus, and Prednisone
Did not experience allograft loss
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 4 monthsFrom the first dose of nivolumab to the date of the first documented tumor progression or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Nivolumab, Tacrolimus, and Prednisone
n=8 Participants
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5 mg by mouth once a day, and nivolumab 480 mg by infusion over 30 minutes on day 1. Cycles repeated every 4 weeks for up to 24 cycles (96 weeks) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Duration of Progression-free Survival After Receiving Nivolumab, Tacrolimus, and Prednisone
|
59 days
Interval 54.0 to 70.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsThe time from the participant's first dose of nivolumab to the date of death from any cause.
Outcome measures
| Measure |
Nivolumab, Tacrolimus, and Prednisone
n=8 Participants
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5 mg by mouth once a day, and nivolumab 480 mg by infusion over 30 minutes on day 1. Cycles repeated every 4 weeks for up to 24 cycles (96 weeks) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Duration of Overall Survival After Receiving Nivolumab, Tacrolimus, and Prednisone
|
9.1 months
Interval 1.9 to 37.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Two participants who completed the initial treatment period did not start the second, optional treatment period due to disease progression or death.
The number of participants with a CR or PR response after receiving ipilimumab, nivolumab, tacrolimus, and prednisone.
Outcome measures
| Measure |
Nivolumab, Tacrolimus, and Prednisone
n=6 Participants
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5 mg by mouth once a day, and nivolumab 480 mg by infusion over 30 minutes on day 1. Cycles repeated every 4 weeks for up to 24 cycles (96 weeks) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate (ORR) in Patients After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone
Complete or Partial Response (CR or PR)
|
2 Participants
|
|
Overall Response Rate (ORR) in Patients After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone
Progressive Disease (PD)
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Two participants who completed the initial treatment period did not start the second, optional treatment period due to disease progression or death.
Number of patients who experienced allograft loss after receiving nivolumab, ipilimumab, tacrolimus, and prednisone.
Outcome measures
| Measure |
Nivolumab, Tacrolimus, and Prednisone
n=6 Participants
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5 mg by mouth once a day, and nivolumab 480 mg by infusion over 30 minutes on day 1. Cycles repeated every 4 weeks for up to 24 cycles (96 weeks) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Rate of Allograft Loss After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone
Experienced allograft loss
|
3 Participants
|
|
Rate of Allograft Loss After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone
Did not experience allograft loss
|
3 Participants
|
Adverse Events
Nivolumab, Tacrolimus, and Prednisone
Serious events: 6 serious events
Other events: 9 other events
Deaths: 4 deaths
Ipilimumab, Nivolumab, Tacrolimus, and Prednisone
Serious events: 6 serious events
Other events: 6 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Nivolumab, Tacrolimus, and Prednisone
n=10 participants at risk
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5mg by mouth once a day, and nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity.
|
Ipilimumab, Nivolumab, Tacrolimus, and Prednisone
n=6 participants at risk
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5mg by mouth once a day, nivolumab 3 mg/kg by infusion and ipilimumab 1 mg/kg by infusion every 3 weeks for 4 doses followed by maintenance nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Nervous system disorders
Lethargy
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
Lung infection
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Vascular disorders
Pseudoaneurysm
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Infections and infestations
Sepsis
|
20.0%
2/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/10 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Gastrointestinal disorders
Small bowel obstruction
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Renal and urinary disorders
Suspected allograft rejection
|
10.0%
1/10 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Renal and urinary disorders
Urinary hesitancy
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Gastrointestinal disorders
Viral gastroenteritis
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Infections and infestations
Wound infection
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
2/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Cardiac disorders
Atrial flutter
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
Cardiac troponin
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Cardiac disorders
Cardiac chest pain
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Psychiatric disorders
Confusion
|
20.0%
2/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
Disease progression
|
30.0%
3/10 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
Fatigue
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
Gait disturbance
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Cardiac disorders
Inferior vena cava stenosis
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Cardiac disorders
Lactic acidosis
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
Other adverse events
| Measure |
Nivolumab, Tacrolimus, and Prednisone
n=10 participants at risk
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5mg by mouth once a day, and nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity.
|
Ipilimumab, Nivolumab, Tacrolimus, and Prednisone
n=6 participants at risk
Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5mg by mouth once a day, nivolumab 3 mg/kg by infusion and ipilimumab 1 mg/kg by infusion every 3 weeks for 4 doses followed by maintenance nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
10.0%
1/10 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Hepatobiliary disorders
Hepatocellular Liver Injury
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
20.0%
2/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
2/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
2/10 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.0%
3/10 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
Infusion site extravasation
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
General disorders
Localized edema
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Gastrointestinal disorders
Loose Stools
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Infections and infestations
Lung infection
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Blood and lymphatic system disorders
Neutrophil Count Increased
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
General disorders
Pain
|
20.0%
2/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Porocarcinoma
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • Up to 3 years
|
50.0%
3/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Vascular disorders
Thromboembolic event
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Investigations
Thyroid stimulating hormone increased
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Tumor Malodor
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
General disorders
Tumor Odor
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Renal and urinary disorders
Urinary hesitancy
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Blood and lymphatic system disorders
White Blood cell Count Increased
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Infections and infestations
Wound infection
|
10.0%
1/10 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
5/10 • Up to 3 years
|
50.0%
3/6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/10 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Blood and lymphatic system disorders
Bleeding at VasCath Site
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Renal and urinary disorders
Blood Urea Nitrogen Increased
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Investigations
Cardiac troponin I increased
|
30.0%
3/10 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Gastrointestinal disorders
Cheilitis
|
10.0%
1/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
General disorders
Chills
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Eye disorders
Corneal dellan, right eye
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Investigations
CPK increased
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Investigations
Creatinine increased
|
30.0%
3/10 • Up to 3 years
|
66.7%
4/6 • Up to 3 years
|
|
Renal and urinary disorders
Cystitis
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
3/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
General disorders
Edema face
|
0.00%
0/10 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
General disorders
Edema limbs
|
10.0%
1/10 • Up to 3 years
|
33.3%
2/6 • Up to 3 years
|
|
Eye disorders
Eye conjunctival tumor
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Eye disorders
Eye redness
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
General disorders
Fatigue
|
40.0%
4/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
General disorders
Fever
|
30.0%
3/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
General disorders
Gait disturbance
|
0.00%
0/10 • Up to 3 years
|
16.7%
1/6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
1/10 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
Additional Information
Grants Administrative Manager
Johns Hopkins University/SKCCC
Phone: 4439273568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60