Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 1595 for:    Pancreatic Cancer | United States

Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

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: NCT00836407
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : December 10, 2013
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Ipilimumab
Biological: Pancreatic Cancer Vaccine
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Ipilimumab Alone Arm 2: Ipilimumab + Pancreatic Cancer Vaccine
Hide Arm/Group Description Ipilimumab alone Ipilimumab + Pancreatic Cancer Vaccine
Period Title: Overall Study
Started 15 15
Completed 4 7
Not Completed 11 8
Arm/Group Title Arm 1: Ipilimumab Alone Arm 2: Ipilimumab + Pancreatic Cancer Vaccine Total
Hide Arm/Group Description Ipilimumab alone Ipilimumab + Pancreatic Cancer Vaccine Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  60.0%
10
  66.7%
19
  63.3%
>=65 years
6
  40.0%
5
  33.3%
11
  36.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
62.3  (7.8) 61.9  (8.9) 62.1  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
4
  26.7%
5
  33.3%
9
  30.0%
Male
11
  73.3%
10
  66.7%
21
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Determine if Ipilimumab Alone or in Combination With Pancreatic Tumor Vaccine Has an Acceptable Safety Profile (Less Than 33% Unacceptable Toxicity) in Subjects With Locally Advanced, Unresectable or Metastatic Pancreatic Adenocarcinoma
Hide Description Unnacceptable toxicities are defined as drug related > grade 4 AEs or grade 3 AE including IRAEs not improving to < grade 2 under therapy within 2 weeks. In addition, > grade 2 eye pain or reduction of visual acuity that does not respond to topical therapy and does not improve to < grade 1 severity within 2 weeks of starting therapy, or requires systemic therapy is an unacceptable toxicity.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Ipilimumab Alone Arm 2: Ipilimumab + Pancreatic Cancer Vaccine
Hide Arm/Group Description:
Ipilimumab alone
Ipilimumab + Pancreatic Cancer Vaccine
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: Percent
6.67 6.67
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Ipilimumab Alone Arm 2: Ipilimumab + Pancreatic Cancer Vaccine
Hide Arm/Group Description:
Ipilimumab alone
Ipilimumab + Pancreatic Cancer Vaccine
Overall Number of Participants Analyzed 15 15
Median (95% Confidence Interval)
Unit of Measure: Months
3.6
(2.5 to 9.2)
5.7
(4.3 to 14.7)
3.Secondary Outcome
Title To Estimate Overall Response Rate (ORR), Immune Related Best Overall Response Rate (irBOR), Progression Free Survival (PFS), and Duration of Response in Patients Receiving Treatment.
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title To Explore an Association Between Immune-related Adverse Events (IRAEs) and ORR.
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title To Measure Tumor Marker Kinetics (CA 19-9) in Patients Receiving Treatment.
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Ipilimumab Alone Arm 2: Ipilimumab + Pancreatic Cancer Vaccine
Hide Arm/Group Description Ipilimumab alone Ipilimumab + Pancreatic Cancer Vaccine
All-Cause Mortality
Arm 1: Ipilimumab Alone Arm 2: Ipilimumab + Pancreatic Cancer Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Ipilimumab Alone Arm 2: Ipilimumab + Pancreatic Cancer Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/15 (20.00%)      1/15 (6.67%)    
Gastrointestinal disorders     
Colitis  1/15 (6.67%)  1 0/15 (0.00%)  0
Nervous system disorders     
Guillain-Barre Syndrome  1/15 (6.67%)  1 0/15 (0.00%)  0
Renal and urinary disorders     
Nephritis  1/15 (6.67%)  1 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonitis  0/15 (0.00%)  0 1/15 (6.67%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1: Ipilimumab Alone Arm 2: Ipilimumab + Pancreatic Cancer Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/15 (73.33%)      15/15 (100.00%)    
Endocrine disorders     
Adrenal insufficiency  0/15 (0.00%)  0 1/15 (6.67%)  1
Hypophysitis  2/15 (13.33%)  2 1/15 (6.67%)  1
Eye disorders     
Conjuntivitis  1/15 (6.67%)  1 0/15 (0.00%)  0
Dry eye  1/15 (6.67%)  1 0/15 (0.00%)  0
Gastrointestinal disorders     
Colitis  2/15 (13.33%)  2 4/15 (26.67%)  4
Anorexia  0/15 (0.00%)  0 2/15 (13.33%)  3
Cramps  1/15 (6.67%)  1 0/15 (0.00%)  0
Diarrhea  0/15 (0.00%)  0 2/15 (13.33%)  2
Nausea  1/15 (6.67%)  1 2/15 (13.33%)  2
General disorders     
Fatigue  0/15 (0.00%)  0 6/15 (40.00%)  7
Fever  3/15 (20.00%)  5 5/15 (33.33%)  12
Flu-like symptoms  2/15 (13.33%)  2 4/15 (26.67%)  8
Musculoskeletal and connective tissue disorders     
Arthralgia  0/15 (0.00%)  0 1/15 (6.67%)  1
Nervous system disorders     
Headache  0/15 (0.00%)  0 3/15 (20.00%)  6
Skin and subcutaneous tissue disorders     
Dry skin  1/15 (6.67%)  1 0/15 (0.00%)  0
Pruritis  4/15 (26.67%)  5 6/15 (40.00%)  14
Rash  6/15 (40.00%)  7 9/15 (60.00%)  23
Urticaria  1/15 (6.67%)  1 1/15 (6.67%)  1
Blister, vaccine site  0/0  0 2/15 (13.33%)  9
Hyperpigmentation, vaccine site  0/0  0 1/15 (6.67%)  1
Pruritis, vaccine site  0/0  0 14/15 (93.33%)  40
Erythema, vaccine site  0/0  0 15/15 (100.00%)  48
Induration, vaccine site  0/0  0 15/15 (100.00%)  53
Tenderness, vaccine site  0/0  0 13/15 (86.67%)  33
Urticaria, vaccine site  0/0  0 1/15 (6.67%)  1
Vaccine Site Flare  0/0  0 1/15 (6.67%)  11
Warmth, vaccine site  0/0  0 2/15 (13.33%)  2
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Dung Le
Organization: The Sidney Kimmel Comprehensive Cancer Center at Johns
EMail: dle@jhmi.edu
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00836407     History of Changes
Other Study ID Numbers: J0834
BMS # CA184-081
First Submitted: February 3, 2009
First Posted: February 4, 2009
Results First Submitted: October 16, 2013
Results First Posted: December 10, 2013
Last Update Posted: December 10, 2013