Trial Outcomes & Findings for Phase II Study of Metastatic Melanoma With Lymphodepleting Conditioning and Anti-gp100:154-162 TCR Gene Engineered Lymphocytes (NCT NCT00509496)
NCT ID: NCT00509496
Last Updated: 2013-01-15
Results Overview
Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD)is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
20 months
Results posted on
2013-01-15
Participant Flow
Participant milestones
| Measure |
Anti-gp100:154-162 TCR PBL + HD IL-2
1. fludarabine phosphate-25 mg/m\^2/day intravenous piggy back over 30 minutes for 5 days
2. cyclophosphamide-60 mg/kg/day x 2 days intravenous
3. Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10\^8 cells and up to 3 x10\^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.
4. aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
|
Anti-gp100:154-162 TCR TIL + HD IL-2
1. fludarabine phosphate-25 mg/m\^2/day intravenous piggy back over 30 minutes for 5 days
2. cyclophosphamide-60 mg/kg/day x 2 days intravenous
3. Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10\^8 cells and up to 3 x10\^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes
4. aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
2
|
|
Overall Study
COMPLETED
|
19
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Metastatic Melanoma With Lymphodepleting Conditioning and Anti-gp100:154-162 TCR Gene Engineered Lymphocytes
Baseline characteristics by cohort
| Measure |
Anti-gp100:154-162 TCR PBL + HD IL-2
n=19 Participants
1. fludarabine phosphate-25 mg/m\^2/day intravenous piggy back over 30 minutes for 5 days
2. cyclophosphamide-60 mg/kg/day x 2 days intravenous
3. Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10\^8 cells and up to 3 x10\^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.
4. aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
|
Anti-gp100:154-162 TCR TIL + HD IL-2
n=2 Participants
1. fludarabine phosphate-25 mg/m\^2/day intravenous piggy back over 30 minutes for 5 days
2. cyclophosphamide-60 mg/kg/day x 2 days intravenous
3. Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10\^8 cells and up to 3 x10\^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes
4. aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age Continuous
|
46.1 years
STANDARD_DEVIATION 10.5 • n=39 Participants
|
28.0 years
STANDARD_DEVIATION 2.8 • n=41 Participants
|
44.4 years
STANDARD_DEVIATION 11.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=39 Participants
|
2 participants
n=41 Participants
|
21 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 20 monthsClinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD)is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Outcome measures
| Measure |
Anti-gp100:154-162 TCR PBL + HD IL-2
n=19 Participants
1. fludarabine phosphate-25 mg/m\^2/day intravenous piggy back over 30 minutes for 5 days
2. cyclophosphamide-60 mg/kg/day x 2 days intravenous
3. Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10\^8 cells and up to 3 x10\^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.
4. aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
|
Anti-gp100:154-162 TCR TIL + HD IL-2
n=2 Participants
1. fludarabine phosphate-25 mg/m\^2/day intravenous piggy back over 30 minutes for 5 days
2. cyclophosphamide-60 mg/kg/day x 2 days intravenous
3. Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10\^8 cells and up to 3 x10\^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes
4. aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
|
|---|---|---|
|
Clinical Tumor Regression.
Complete Response
|
1 Participants
|
0 Participants
|
|
Clinical Tumor Regression.
Partial Response
|
2 Participants
|
1 Participants
|
|
Clinical Tumor Regression.
Progressive Disease
|
16 Participants
|
1 Participants
|
|
Clinical Tumor Regression.
Stable Disease
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 yearsHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Anti-gp100:154-162 TCR PBL + HD IL-2
n=19 Participants
1. fludarabine phosphate-25 mg/m\^2/day intravenous piggy back over 30 minutes for 5 days
2. cyclophosphamide-60 mg/kg/day x 2 days intravenous
3. Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10\^8 cells and up to 3 x10\^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.
4. aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
|
Anti-gp100:154-162 TCR TIL + HD IL-2
n=2 Participants
1. fludarabine phosphate-25 mg/m\^2/day intravenous piggy back over 30 minutes for 5 days
2. cyclophosphamide-60 mg/kg/day x 2 days intravenous
3. Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10\^8 cells and up to 3 x10\^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes
4. aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
|
|---|---|---|
|
Toxicity
|
19 Participants
|
2 Participants
|
Adverse Events
Anti-gp100:154-162 TCR PBL + HD IL-2
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Anti-gp100:154-162 TCR TIL + HD IL-2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anti-gp100:154-162 TCR PBL + HD IL-2
n=19 participants at risk
1. fludarabine phosphate-25 mg/m\^2/day intravenous piggy back over 30 minutes for 5 days
2. cyclophosphamide-60 mg/kg/day x 2 days intravenous
3. Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10\^8 cells and up to 3 x10\^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.
4. aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
|
Anti-gp100:154-162 TCR TIL + HD IL-2
n=2 participants at risk
1. fludarabine phosphate-25 mg/m\^2/day intravenous piggy back over 30 minutes for 5 days
2. cyclophosphamide-60 mg/kg/day x 2 days intravenous
3. Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10\^8 cells and up to 3 x10\^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes
4. aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
10.5%
2/19 • Number of events 2
|
0.00%
0/2
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Creatinine
|
15.8%
3/19 • Number of events 4
|
0.00%
0/2
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
10.5%
2/19 • Number of events 2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Renal and urinary disorders
Renal failure
|
10.5%
2/19 • Number of events 2
|
0.00%
0/2
|
|
Vascular disorders
Acute vascular leak syndrome
|
10.5%
2/19 • Number of events 2
|
0.00%
0/2
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
Other adverse events
| Measure |
Anti-gp100:154-162 TCR PBL + HD IL-2
n=19 participants at risk
1. fludarabine phosphate-25 mg/m\^2/day intravenous piggy back over 30 minutes for 5 days
2. cyclophosphamide-60 mg/kg/day x 2 days intravenous
3. Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10\^8 cells and up to 3 x10\^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.
4. aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
|
Anti-gp100:154-162 TCR TIL + HD IL-2
n=2 participants at risk
1. fludarabine phosphate-25 mg/m\^2/day intravenous piggy back over 30 minutes for 5 days
2. cyclophosphamide-60 mg/kg/day x 2 days intravenous
3. Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10\^8 cells and up to 3 x10\^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes
4. aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
|
|---|---|---|
|
Ear and labyrinth disorders
Hearing: patients with/without baseline audiogram
|
42.1%
8/19 • Number of events 8
|
100.0%
2/2 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
15.8%
3/19 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
78.9%
15/19 • Number of events 22
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
19/19 • Number of events 21
|
100.0%
2/2 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
19/19 • Number of events 22
|
100.0%
2/2 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
19/19 • Number of events 22
|
100.0%
2/2 • Number of events 3
|
|
Blood and lymphatic system disorders
Platelets
|
94.7%
18/19 • Number of events 18
|
100.0%
2/2 • Number of events 2
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
15.8%
3/19 • Number of events 3
|
0.00%
0/2
|
|
Cardiac disorders
Vasovagal episode
|
10.5%
2/19 • Number of events 2
|
0.00%
0/2
|
|
Cardiac disorders
Hypotension
|
26.3%
5/19 • Number of events 5
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
26.3%
5/19 • Number of events 5
|
0.00%
0/2
|
|
General disorders
Constitutional Symptoms-Other (Specify, inability to tolerate IL-2)
|
21.1%
4/19 • Number of events 4
|
0.00%
0/2
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
31.6%
6/19 • Number of events 6
|
0.00%
0/2
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
15.8%
3/19 • Number of events 3
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Insomnia
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Weight loss
|
10.5%
2/19 • Number of events 2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Flushing
|
10.5%
2/19 • Number of events 2
|
100.0%
2/2 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
5.3%
1/19 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
84.2%
16/19 • Number of events 17
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Dehydration
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Diarrhea
|
10.5%
2/19 • Number of events 2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Nausea
|
21.1%
4/19 • Number of events 4
|
0.00%
0/2
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Number of events 2
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Hemorrhage, GU
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding - Other (hemorrhage)
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
15.8%
3/19 • Number of events 4
|
50.0%
1/2 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
15.8%
3/19 • Number of events 3
|
0.00%
0/2
|
|
Infections and infestations
Infection with unknown ANC
|
10.5%
2/19 • Number of events 3
|
0.00%
0/2
|
|
Infections and infestations
Febrile neutropenia
|
52.6%
10/19 • Number of events 10
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
5.3%
1/19 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
21.1%
4/19 • Number of events 4
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
68.4%
13/19 • Number of events 14
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
15.8%
3/19 • Number of events 3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Amylase
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
31.6%
6/19 • Number of events 6
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
42.1%
8/19 • Number of events 10
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Creatinine
|
15.8%
3/19 • Number of events 3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Lipase
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
26.3%
5/19 • Number of events 5
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
36.8%
7/19 • Number of events 9
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
26.3%
5/19 • Number of events 5
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
26.3%
5/19 • Number of events 5
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
15.8%
3/19 • Number of events 4
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Arachnoiditis/meningismus/radiculitis
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Confusion
|
31.6%
6/19 • Number of events 6
|
0.00%
0/2
|
|
Nervous system disorders
Dizziness
|
42.1%
8/19 • Number of events 8
|
0.00%
0/2
|
|
Nervous system disorders
Mood alteration
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Eye disorders
Dry eye syndrome
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Eye disorders
Nystagmus
|
5.3%
1/19 • Number of events 1
|
0.00%
0/2
|
|
Eye disorders
Uveitis
|
31.6%
6/19 • Number of events 7
|
50.0%
1/2 • Number of events 1
|
|
Eye disorders
Vision-blurred vision
|
15.8%
3/19 • Number of events 3
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Pain
|
15.8%
3/19 • Number of events 6
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
21.1%
4/19 • Number of events 4
|
100.0%
2/2 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
26.3%
5/19 • Number of events 5
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
10.5%
2/19 • Number of events 2
|
0.00%
0/2
|
|
Renal and urinary disorders
Renal failure
|
10.5%
2/19 • Number of events 2
|
0.00%
0/2
|
|
Vascular disorders
Acute vascular leak syndrome
|
42.1%
8/19 • Number of events 8
|
50.0%
1/2 • Number of events 1
|
Additional Information
Dr. Steven Rosenberg
National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place