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First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01524991
Recruitment Status : Completed
First Posted : February 2, 2012
Results First Posted : November 29, 2019
Last Update Posted : November 29, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Hoosier Cancer Research Network

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urothelial Carcinoma
Interventions Drug: Gemcitabine
Drug: Cisplatin
Drug: Ipilimumab
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description

Gemcitabine 1000 mg/m2 Days 1 & 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 & 8 (all cycles)

Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)

Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Period Title: Overall Study
Started 36
Completed 2
Not Completed 34
Reason Not Completed
Adverse Event             12
Death             1
Disease ProgressionDu             17
Other complicating disease             1
Withdrawal by Subject             2
Symptomatic Deterioration             1
Arm/Group Title Treatment
Hide Arm/Group Description

Gemcitabine 1000 mg/m2 Days 1 & 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 & 8 (all cycles)

Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)

Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 36 participants
36
(33 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
7
  19.4%
Male
29
  80.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Hispanic or Latino
4
  11.1%
Not Hispanic or Latino
32
  88.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   2.8%
White
35
  97.2%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
Karnovsky Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
KPS 100
9
  25.0%
KPS 90
16
  44.4%
KPS 80
11
  30.6%
[1]
Measure Description: Karnofsky Performance Status (KPS) is a general indicator of a subject's well being and ability to carry on daily activities. The KPS scale ranges from 0-100 in 10 unit increments where 100=Normal; no complaints; no evidence of disease and 0=Dead
1.Primary Outcome
Title Median Overall Survival
Hide Description To determine the median overall survival of patients with advanced/metastatic urothelial cancer treated with gemcitabine, cisplatin, plus ipilimumab, calculated from the date of registration until the date of final analysis, projected to be 48 months from the start of the study.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

Gemcitabine 1000 mg/m2 Days 1 & 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 & 8 (all cycles)

Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)

Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Overall Number of Participants Analyzed 36
Median (95% Confidence Interval)
Unit of Measure: months
13.9
(10.5 to 23.4)
2.Secondary Outcome
Title Progression-Free Survival
Hide Description

To determine the progression-free survival (using irRC and RECIST v1.0) of patients with advanced/metastatic urothelial carcinoma treated with gemcitabine, cisplatin, and ipilimumab.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression is definied by IrRC as "at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 wk apart."

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

Gemcitabine 1000 mg/m2 Days 1 & 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 & 8 (all cycles)

Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)

Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Overall Number of Participants Analyzed 36
Median (95% Confidence Interval)
Unit of Measure: months
7.9
(6.4 to 9.9)
3.Secondary Outcome
Title Best Overall Response Rate
Hide Description To determine the best overall response rate to treatment with gemcitabine, cisplatin, plus ipilimumab, per RECIST 1.1 criteria.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

Gemcitabine 1000 mg/m2 Days 1 & 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 & 8 (all cycles)

Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)

Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (CR)
6
  16.7%
Partial Response (PR)
19
  52.8%
Stable Disease (SD)
10
  27.8%
Progressive Disease (PD)
1
   2.8%
4.Secondary Outcome
Title Number of Adverse Events Experienced by Patients
Hide Description To determine the safety of treatment with gemcitabine, cisplatin, plus ipilimumab. The highest grade adverse event for each subject is presented.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

Gemcitabine 1000 mg/m2 Days 1 & 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 & 8 (all cycles)

Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)

Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
1
   2.8%
Grade 2
6
  16.7%
Grade 3
19
  52.8%
Grade 4
10
  27.8%
Time Frame From the start of treatment to 30 days following the last treatment, a maximum of 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description

Gemcitabine 1000 mg/m2 Days 1 & 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 & 8 (all cycles)

Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)

Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)

All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   28/36 (77.78%)    
Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   18/36 (50.00%)    
Blood and lymphatic system disorders   
ANEMIA * 1  1/36 (2.78%)  1
Cardiac disorders   
ATRIAL FIBRILLATION * 1  2/36 (5.56%)  2
Endocrine disorders   
ADRENAL INSUFFICIENCY * 1  1/36 (2.78%)  1
ENDOCRINE DISORDERS - OTHER, SPECIFY * 1  1/36 (2.78%)  1
HYPERTHYROIDISM * 1  1/36 (2.78%)  1
Gastrointestinal disorders   
COLITIS * 1  1/36 (2.78%)  2
DIARRHEA * 1  2/36 (5.56%)  3
OBSTRUCTION GASTRIC * 1  1/36 (2.78%)  1
RECTAL PAIN * 1  1/36 (2.78%)  1
SMALL INTESTINAL OBSTRUCTION * 1  1/36 (2.78%)  2
UPPER GASTROINTESTINAL HEMORRHAGE * 1  1/36 (2.78%)  1
General disorders   
FEVER * 1  4/36 (11.11%)  5
Immune system disorders   
AUTOIMMUNE DISORDER * 1  2/36 (5.56%)  3
Infections and infestations   
LUNG INFECTION * 1  1/36 (2.78%)  1
SEPSIS * 1  1/36 (2.78%)  1
UPPER RESPIRATORY INFECTION * 1  1/36 (2.78%)  1
URINARY TRACT INFECTION * 1  3/36 (8.33%)  3
Investigations   
CREATININE INCREASED * 1  1/36 (2.78%)  1
Metabolism and nutrition disorders   
HYPONATREMIA * 1  1/36 (2.78%)  2
Nervous system disorders   
PERIPHERAL MOTOR NEUROPATHY * 1  1/36 (2.78%)  1
Renal and urinary disorders   
ACUTE KIDNEY INJURY * 1  3/36 (8.33%)  3
Vascular disorders   
THROMBOEMBOLIC EVENT * 1  5/36 (13.89%)  9
1
Term from vocabulary, CTCAEv4
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment
Affected / at Risk (%) # Events
Total   36/36 (100.00%)    
Blood and lymphatic system disorders   
ANEMIA * 1  24/36 (66.67%)  109
LEUKOCYTOSIS * 1  1/36 (2.78%)  1
Cardiac disorders   
ATRIAL FIBRILLATION * 1  3/36 (8.33%)  4
CHEST PAIN - CARDIAC * 1  1/36 (2.78%)  1
PALPITATIONS * 1  2/36 (5.56%)  2
SINUS BRADYCARDIA * 1  1/36 (2.78%)  1
SINUS TACHYCARDIA * 1  1/36 (2.78%)  1
Ear and labyrinth disorders   
EAR PAIN * 1  1/36 (2.78%)  1
HEARING IMPAIRED * 1  1/36 (2.78%)  1
TINNITUS * 1  4/36 (11.11%)  7
Endocrine disorders   
ADRENAL INSUFFICIENCY * 1  2/36 (5.56%)  2
ENDOCRINE DISORDERS - OTHER, SPECIFY * 1  4/36 (11.11%)  5
HYPERTHYROIDISM * 1  2/36 (5.56%)  2
HYPOTHYROIDISM * 1  4/36 (11.11%)  5
Eye disorders   
BLURRED VISION * 1  4/36 (11.11%)  4
CATARACT * 1  1/36 (2.78%)  1
Gastrointestinal disorders   
ABDOMINAL DISTENSION * 1  1/36 (2.78%)  1
ABDOMINAL PAIN * 1  14/36 (38.89%)  19
ASCITES * 1  1/36 (2.78%)  1
BLOATING * 1  1/36 (2.78%)  1
COLITIS * 1  4/36 (11.11%)  4
CONSTIPATION * 1  24/36 (66.67%)  34
DIARRHEA * 1  23/36 (63.89%)  40
DYSPEPSIA * 1  9/36 (25.00%)  11
DYSPHAGIA * 1  1/36 (2.78%)  2
GASTROESOPHAGEAL REFLUX DISEASE * 1  5/36 (13.89%)  5
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY * 1  2/36 (5.56%)  2
GASTROINTESTINAL PAIN * 1  1/36 (2.78%)  1
MUCOSITIS ORAL * 1  4/36 (11.11%)  6
NAUSEA * 1  27/36 (75.00%)  64
OBSTRUCTION GASTRIC * 1  1/36 (2.78%)  1
ORAL PAIN * 1  1/36 (2.78%)  1
RECTAL HEMORRHAGE * 1  2/36 (5.56%)  2
RECTAL PAIN * 1  1/36 (2.78%)  2
SMALL INTESTINAL OBSTRUCTION * 1  1/36 (2.78%)  1
VOMITING * 1  14/36 (38.89%)  35
General disorders   
CHILLS * 1  7/36 (19.44%)  9
EDEMA LIMBS * 1  11/36 (30.56%)  15
FATIGUE * 1  33/36 (91.67%)  71
FEVER * 1  12/36 (33.33%)  17
FLU LIKE SYMPTOMS * 1  2/36 (5.56%)  2
GAIT DISTURBANCE * 1  1/36 (2.78%)  1
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY * 1  2/36 (5.56%)  2
LOCALIZED EDEMA * 1  1/36 (2.78%)  1
MALAISE * 1  1/36 (2.78%)  1
NON-CARDIAC CHEST PAIN * 1  2/36 (5.56%)  2
PAIN * 1  15/36 (41.67%)  22
Immune system disorders   
ALLERGIC REACTION * 1  1/36 (2.78%)  1
Infections and infestations   
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY * 1  4/36 (11.11%)  5
KIDNEY INFECTION * 1  1/36 (2.78%)  1
LIP INFECTION * 1  1/36 (2.78%)  1
PAPULOPUSTULAR RASH * 1  1/36 (2.78%)  1
RASH PUSTULAR * 1  1/36 (2.78%)  1
SKIN INFECTION * 1  5/36 (13.89%)  7
SMALL INTESTINE INFECTION * 1  1/36 (2.78%)  1
UPPER RESPIRATORY INFECTION * 1  1/36 (2.78%)  1
URINARY TRACT INFECTION * 1  11/36 (30.56%)  14
WOUND INFECTION * 1  1/36 (2.78%)  1
Injury, poisoning and procedural complications   
BRUISING * 1  1/36 (2.78%)  1
FALL * 1  1/36 (2.78%)  1
INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY * 1  1/36 (2.78%)  3
Investigations   
ALANINE AMINOTRANSFERASE INCREASED * 1  5/36 (13.89%)  7
ALKALINE PHOSPHATASE INCREASED * 1  5/36 (13.89%)  10
ASPARTATE AMINOTRANSFERASE INCREASED * 1  4/36 (11.11%)  7
BLOOD BILIRUBIN INCREASED * 1  1/36 (2.78%)  1
CHOLESTEROL HIGH * 1  4/36 (11.11%)  4
CREATININE INCREASED * 1  12/36 (33.33%)  26
INVESTIGATIONS - OTHER, SPECIFY * 1  1/36 (2.78%)  1
LYMPHOCYTE COUNT DECREASED * 1  5/36 (13.89%)  13
NEUTROPHIL COUNT DECREASED * 1  21/36 (58.33%)  56
PLATELET COUNT DECREASED * 1  17/36 (47.22%)  38
WEIGHT GAIN * 1  2/36 (5.56%)  9
WEIGHT LOSS * 1  7/36 (19.44%)  12
WHITE BLOOD CELL DECREASED * 1  7/36 (19.44%)  18
Metabolism and nutrition disorders   
ANOREXIA * 1  19/36 (52.78%)  30
DEHYDRATION * 1  7/36 (19.44%)  11
HYPERCALCEMIA * 1  1/36 (2.78%)  2
HYPERGLYCEMIA * 1  6/36 (16.67%)  9
HYPERKALEMIA * 1  4/36 (11.11%)  9
HYPERTRIGLYCERIDEMIA * 1  2/36 (5.56%)  2
HYPERURICEMIA * 1  1/36 (2.78%)  1
HYPOALBUMINEMIA * 1  5/36 (13.89%)  18
HYPOCALCEMIA * 1  3/36 (8.33%)  3
HYPOGLYCEMIA * 1  1/36 (2.78%)  2
HYPOKALEMIA * 1  9/36 (25.00%)  19
HYPOMAGNESEMIA * 1  9/36 (25.00%)  26
HYPONATREMIA * 1  17/36 (47.22%)  41
HYPOPHOSPHATEMIA * 1  3/36 (8.33%)  3
METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY * 1  1/36 (2.78%)  1
OBESITY * 1  1/36 (2.78%)  1
Musculoskeletal and connective tissue disorders   
ARTHRALGIA * 1  4/36 (11.11%)  4
ARTHRITIS * 1  1/36 (2.78%)  1
BACK PAIN * 1  11/36 (30.56%)  17
BONE PAIN * 1  4/36 (11.11%)  4
CHEST WALL PAIN * 1  1/36 (2.78%)  1
FLANK PAIN * 1  6/36 (16.67%)  8
GENERALIZED MUSCLE WEAKNESS * 1  4/36 (11.11%)  5
MUSCLE WEAKNESS UPPER LIMB * 1  1/36 (2.78%)  1
MYALGIA * 1  1/36 (2.78%)  1
NECK PAIN * 1  1/36 (2.78%)  1
PAIN IN EXTREMITY * 1  10/36 (27.78%)  15
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY * 1  1/36 (2.78%)  1
Nervous system disorders   
DIZZINESS * 1  11/36 (30.56%)  14
DYSGEUSIA * 1  11/36 (30.56%)  13
ENCEPHALOPATHY * 1  1/36 (2.78%)  1
HEADACHE * 1  12/36 (33.33%)  17
MEMORY IMPAIRMENT * 1  1/36 (2.78%)  1
NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY * 1  1/36 (2.78%)  1
NEURALGIA * 1  1/36 (2.78%)  1
PARESTHESIA * 1  2/36 (5.56%)  2
PERIPHERAL MOTOR NEUROPATHY * 1  1/36 (2.78%)  1
PERIPHERAL SENSORY NEUROPATHY * 1  16/36 (44.44%)  20
SOMNOLENCE * 1  1/36 (2.78%)  1
SYNCOPE * 1  1/36 (2.78%)  1
TREMOR * 1  3/36 (8.33%)  3
Psychiatric disorders   
AGITATION * 1  2/36 (5.56%)  2
ANXIETY * 1  7/36 (19.44%)  7
DELIRIUM * 1  2/36 (5.56%)  2
DEPRESSION * 1  6/36 (16.67%)  6
INSOMNIA * 1  11/36 (30.56%)  12
RESTLESSNESS * 1  1/36 (2.78%)  1
Renal and urinary disorders   
BLADDER SPASM * 1  1/36 (2.78%)  1
HEMATURIA * 1  10/36 (27.78%)  11
PROTEINURIA * 1  1/36 (2.78%)  1
RENAL AND URINARY DISORDERS - OTHER, SPECIFY * 1  7/36 (19.44%)  9
RENAL CALCULI * 1  1/36 (2.78%)  1
URINARY FREQUENCY * 1  6/36 (16.67%)  7
URINARY INCONTINENCE * 1  2/36 (5.56%)  2
URINARY RETENTION * 1  2/36 (5.56%)  2
URINARY TRACT PAIN * 1  1/36 (2.78%)  1
URINARY URGENCY * 1  1/36 (2.78%)  1
Reproductive system and breast disorders   
ERECTILE DYSFUNCTION * 1  1/36 (2.78%)  1
GENITAL EDEMA * 1  2/36 (5.56%)  2
PELVIC PAIN * 1  3/36 (8.33%)  3
PROSTATIC OBSTRUCTION * 1  1/36 (2.78%)  1
Respiratory, thoracic and mediastinal disorders   
ALLERGIC RHINITIS * 1  4/36 (11.11%)  4
COUGH * 1  18/36 (50.00%)  24
DYSPNEA * 1  16/36 (44.44%)  18
EPISTAXIS * 1  2/36 (5.56%)  4
HICCUPS * 1  5/36 (13.89%)  5
HOARSENESS * 1  1/36 (2.78%)  1
HYPOXIA * 1  2/36 (5.56%)  2
NASAL CONGESTION * 1  3/36 (8.33%)  3
PNEUMONITIS * 1  2/36 (5.56%)  2
PRODUCTIVE COUGH * 1  1/36 (2.78%)  2
PULMONARY EDEMA * 1  2/36 (5.56%)  2
PULMONARY FIBROSIS * 1  1/36 (2.78%)  1
RESPIRATORY FAILURE * 1  1/36 (2.78%)  1
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY * 1  1/36 (2.78%)  1
SINUS DISORDER * 1  1/36 (2.78%)  1
SNEEZING * 1  2/36 (5.56%)  3
SORE THROAT * 1  3/36 (8.33%)  6
Skin and subcutaneous tissue disorders   
ALOPECIA * 1  10/36 (27.78%)  12
DRY SKIN * 1  4/36 (11.11%)  4
ERYTHEMA MULTIFORME * 1  1/36 (2.78%)  1
HYPERHIDROSIS * 1  1/36 (2.78%)  1
PAIN OF SKIN * 1  1/36 (2.78%)  1
PRURITUS * 1  7/36 (19.44%)  9
PURPURA * 1  1/36 (2.78%)  1
RASH ACNEIFORM * 1  7/36 (19.44%)  9
RASH MACULO-PAPULAR * 1  7/36 (19.44%)  13
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY * 1  6/36 (16.67%)  6
SKIN ULCERATION * 1  1/36 (2.78%)  1
Surgical and medical procedures   
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY * 1  2/36 (5.56%)  2
Vascular disorders   
HOT FLASHES * 1  1/36 (2.78%)  1
HYPERTENSION * 1  10/36 (27.78%)  11
HYPOTENSION * 1  2/36 (5.56%)  3
LYMPHEDEMA * 1  1/36 (2.78%)  1
PHLEBITIS * 1  1/36 (2.78%)  1
SUPERFICIAL THROMBOPHLEBITIS * 1  2/36 (5.56%)  2
THROMBOEMBOLIC EVENT * 1  6/36 (16.67%)  7
VASCULAR DISORDERS - OTHER, SPECIFY * 1  1/36 (2.78%)  1
1
Term from vocabulary, CTCAEv4
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinicaltrials.gov Results Coordinator
Organization: Hoosier Cancer Research Network
Phone: 317-643-5842 ext 41
EMail: jsmith@hoosiercancer.org
Publications:
Galsky MD, Hahn NM, Albany C, Fleming MT, Starodub A, Twardowski P, Hauke RJ, Sonpavde G, Merad M, Gnjatic S, Bhardwaj N, Chippada-Venkata U, Oh WK, Kim-Schulze S. Impact of gemcitabine + cisplatin + ipilimumab on circulating immune cells in patients (pts) with metastatic urothelial cancer (mUC). J Clin Oncol 33:5s, 2015 (suppl; abstr 4586)
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Responsible Party: Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT01524991    
Other Study ID Numbers: GU10-148
First Submitted: January 30, 2012
First Posted: February 2, 2012
Results First Submitted: October 22, 2019
Results First Posted: November 29, 2019
Last Update Posted: November 29, 2019