Trial Outcomes & Findings for Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer (NCT NCT00836407)

Last Updated: 2020-02-24

Results Overview

Unacceptable toxicity is defined as drug related \>grade 4 AEs or grade 3 AEs 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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

4 years

Results posted on

2020-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: Ipilimumab Alone Ipilimumab (10mg/kg) will be administered intravenously at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.	Arm 2: Ipilimumab + Pancreatic Cancer Vaccine Drug: Ipilimumab Ipilimumab (10mg/kg) will be administered intravenously at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks. Biological/Vaccine: Pancreatic Cancer Vaccine The Pancreatic Cancer Vaccine (5E8 cells) will be administered intradermally at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.
Overall Study STARTED	15	15
Overall Study COMPLETED	4	7
Overall Study NOT COMPLETED	11	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Ipilimumab Alone n=15 Participants Ipilimumab alone	Arm 2: Ipilimumab + Pancreatic Cancer Vaccine n=15 Participants Ipilimumab + Pancreatic Cancer Vaccine	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Continuous	62.3 years STANDARD_DEVIATION 7.8 • n=5 Participants	61.9 years STANDARD_DEVIATION 8.9 • n=7 Participants	62.1 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 years

Outcome measures

Outcome measures
Measure	Arm 1: Ipilimumab Alone n=15 Participants Ipilimumab alone	Arm 2: Ipilimumab + Pancreatic Cancer Vaccine n=15 Participants Ipilimumab + Pancreatic Cancer Vaccine
Percent of Patients Experiencing an Unacceptable Toxicity	6.67 Percentage of Participants	6.67 Percentage of Participants

SECONDARY outcome

Timeframe: 4 years

OS will be measured from date of randomization until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis).

Outcome measures

Outcome measures
Measure	Arm 1: Ipilimumab Alone n=15 Participants Ipilimumab alone	Arm 2: Ipilimumab + Pancreatic Cancer Vaccine n=15 Participants Ipilimumab + Pancreatic Cancer Vaccine
Overall Survival (OS)	3.6 Months Interval 2.5 to 9.2	5.7 Months Interval 4.3 to 14.7

SECONDARY outcome

Timeframe: 6 months

ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) during the first 6 months of treatment. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Immune Related Best Overall Response (BOR) is the best response recorded from the start of the study treatment until the disease progression/recurrence based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

PFS is defined as the number of months from the date of randomization to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1: Ipilimumab Alone

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Arm 2: Ipilimumab + Pancreatic Cancer Vaccine

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: Ipilimumab Alone n=15 participants at risk Ipilimumab alone	Arm 2: Ipilimumab + Pancreatic Cancer Vaccine n=15 participants at risk Ipilimumab + Pancreatic Cancer Vaccine
Renal and urinary disorders Nephritis	6.7% 1/15 • Number of events 1	0.00% 0/15
Gastrointestinal disorders Colitis	6.7% 1/15 • Number of events 1	0.00% 0/15
Nervous system disorders Guillain-Barre Syndrome	6.7% 1/15 • Number of events 1	0.00% 0/15
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/15	6.7% 1/15 • Number of events 1

Other adverse events

Other adverse events
Measure	Arm 1: Ipilimumab Alone n=15 participants at risk Ipilimumab alone	Arm 2: Ipilimumab + Pancreatic Cancer Vaccine n=15 participants at risk Ipilimumab + Pancreatic Cancer Vaccine
Endocrine disorders Adrenal insufficiency	0.00% 0/15	6.7% 1/15 • Number of events 1
Endocrine disorders Hypophysitis	13.3% 2/15 • Number of events 2	6.7% 1/15 • Number of events 1
Eye disorders Conjuntivitis	6.7% 1/15 • Number of events 1	0.00% 0/15
Gastrointestinal disorders Colitis	13.3% 2/15 • Number of events 2	26.7% 4/15 • Number of events 4
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/15	6.7% 1/15 • Number of events 1
Gastrointestinal disorders Anorexia	0.00% 0/15	13.3% 2/15 • Number of events 3
Gastrointestinal disorders Cramps	6.7% 1/15 • Number of events 1	0.00% 0/15
Gastrointestinal disorders Diarrhea	0.00% 0/15	13.3% 2/15 • Number of events 2
Eye disorders Dry eye	6.7% 1/15 • Number of events 1	0.00% 0/15
Skin and subcutaneous tissue disorders Dry skin	6.7% 1/15 • Number of events 1	0.00% 0/15
General disorders Fatigue	0.00% 0/15	40.0% 6/15 • Number of events 7
General disorders Fever	20.0% 3/15 • Number of events 5	33.3% 5/15 • Number of events 12
General disorders Flu-like symptoms	13.3% 2/15 • Number of events 2	26.7% 4/15 • Number of events 8
Nervous system disorders Headache	0.00% 0/15	20.0% 3/15 • Number of events 6
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1	13.3% 2/15 • Number of events 2
Skin and subcutaneous tissue disorders Pruritis	26.7% 4/15 • Number of events 5	40.0% 6/15 • Number of events 14
Skin and subcutaneous tissue disorders Rash	40.0% 6/15 • Number of events 7	60.0% 9/15 • Number of events 23
Skin and subcutaneous tissue disorders Urticaria	6.7% 1/15 • Number of events 1	6.7% 1/15 • Number of events 1
Skin and subcutaneous tissue disorders Blister, vaccine site	— 0/0	13.3% 2/15 • Number of events 9
Skin and subcutaneous tissue disorders Hyperpigmentation, vaccine site	— 0/0	6.7% 1/15 • Number of events 1
Skin and subcutaneous tissue disorders Pruritis, vaccine site	— 0/0	93.3% 14/15 • Number of events 40
Skin and subcutaneous tissue disorders Erythema, vaccine site	— 0/0	100.0% 15/15 • Number of events 48
Skin and subcutaneous tissue disorders Induration, vaccine site	— 0/0	100.0% 15/15 • Number of events 53
Skin and subcutaneous tissue disorders Tenderness, vaccine site	— 0/0	86.7% 13/15 • Number of events 33
Skin and subcutaneous tissue disorders Urticaria, vaccine site	— 0/0	6.7% 1/15 • Number of events 1
Skin and subcutaneous tissue disorders Vaccine Site Flare	— 0/0	6.7% 1/15 • Number of events 11
Skin and subcutaneous tissue disorders Warmth, vaccine site	— 0/0	13.3% 2/15 • Number of events 2

Additional Information

Dr. Dung Le

The Sidney Kimmel Comprehensive Cancer Center at Johns

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place