Trial Outcomes & Findings for A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM) (NCT NCT01280552)

Last Updated: 2017-03-20

Results Overview

The objective is to compare overall survival (OS) in patients when treated with ICT 107 versus Control. OS defined as the time from randomization until date of death or the last date patient known alive (if death is not observed) All randomized patients are included in Intent to Treat analysis

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

124 participants

Primary outcome timeframe

2 -3 years

Results posted on

2017-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	ICT-107 Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens ICT-107: Autologous dendritic cells pulsed with immunogenic antigens	Placebo Autologous dendritic cells that have not been pulsed with antigens Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens
Overall Study STARTED	81	43
Overall Study COMPLETED	75	42
Overall Study NOT COMPLETED	6	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ICT-107 n=81 Participants Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens ICT-107: Autologous dendritic cells pulsed with immunogenic antigens	Placebo n=43 Participants Autologous dendritic cells that have not been pulsed with antigens Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens	Total n=124 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	59 Participants n=5 Participants	29 Participants n=7 Participants	88 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	14 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	12 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	31 Participants n=7 Participants	75 Participants n=5 Participants
Region of Enrollment United States	81 participants n=5 Participants	43 participants n=7 Participants	124 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 -3 years

Population: Intent to treat include all randomized patients

Outcome measures

Outcome measures
Measure	ICT-107 n=81 Participants Treatment with autologous dendritic cells pulsed with immunogenic peptides	Control Dendritic Cells n=43 Participants Treatment with autologous dendritic cells not pulsed with immunogenic peptides
Overall Survival (OS)	18.3 months of survival Interval 14.9 to 21.2	16.7 months of survival Interval 12.3 to 23.0

PRIMARY outcome

Timeframe: 2-3 years

Population: Patients with HLA-A2 haplotype

Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.

Outcome measures

Outcome measures
Measure	ICT-107 n=48 Participants Treatment with autologous dendritic cells pulsed with immunogenic peptides	Control Dendritic Cells n=29 Participants Treatment with autologous dendritic cells not pulsed with immunogenic peptides
Overall Survival in HLA-A2 Patients	18.3 months of survival Interval 13.2 to 21.1	12.9 months of survival Interval 10.2 to 19.1

SECONDARY outcome

Timeframe: 2-3 years

Population: Intent to treat includes all randomized patients

Secondary Endpoints * PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed. * Population is all randomized patients ITT.

Outcome measures

Outcome measures
Measure	ICT-107 n=81 Participants Treatment with autologous dendritic cells pulsed with immunogenic peptides	Control Dendritic Cells n=43 Participants Treatment with autologous dendritic cells not pulsed with immunogenic peptides
PFS	11.2 months of progression free survival Interval 8.2 to 13.0	9.0 months of progression free survival Interval 5.5 to 10.3

SECONDARY outcome

Timeframe: 2-3 yers

Population: HLA-A2 patients

Progression Free Survival in a prespecified subpopulation of patients with HLA-A2 haplotype. Intent to treat population includes all randomized patients. PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed

Outcome measures

Outcome measures
Measure	ICT-107 n=48 Participants Treatment with autologous dendritic cells pulsed with immunogenic peptides	Control Dendritic Cells n=29 Participants Treatment with autologous dendritic cells not pulsed with immunogenic peptides
Progression Free Survival in HLA- A2 Patients	11.2 months of progression free survival Interval 6.5 to 14.0	7.2 months of progression free survival Interval 4.6 to 10.2

Adverse Events

ICT-107

Serious events: 8 serious events

Other events: 59 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ICT-107 n=80 participants at risk Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens ICT-107: Autologous dendritic cells pulsed with immunogenic antigens	Placebo n=43 participants at risk Autologous dendritic cells that have not been pulsed with antigens Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens
Nervous system disorders seizure	10.0% 8/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	16.3% 7/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Nervous system disorders cerebral edema	2.5% 2/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	2.3% 1/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Infections and infestations infection	5.0% 4/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	9.3% 4/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.00% 0/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	7.0% 3/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Nervous system disorders intracranial hemorrhage	5.0% 4/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	0.00% 0/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Nervous system disorders increased intracranial pressure	2.5% 2/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	0.00% 0/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.

Other adverse events

Other adverse events
Measure	ICT-107 n=80 participants at risk Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens ICT-107: Autologous dendritic cells pulsed with immunogenic antigens	Placebo n=43 participants at risk Autologous dendritic cells that have not been pulsed with antigens Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens
Nervous system disorders convulsion	13.8% 11/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	16.3% 7/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
General disorders fatigue	15.0% 12/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	25.6% 11/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Gastrointestinal disorders nausea	7.5% 6/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	9.3% 4/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Blood and lymphatic system disorders thrombocytopenia	3.8% 3/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	7.0% 3/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Infections and infestations urinary tract infection	6.2% 5/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	4.7% 2/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Psychiatric disorders insomnia	3.8% 3/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	9.3% 4/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Metabolism and nutrition disorders decreased appetite	2.5% 2/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	7.0% 3/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Infections and infestations upper respiratory tract infection	0.00% 0/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	7.0% 3/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Investigations white blood cell count decreased	5.0% 4/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	0.00% 0/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Musculoskeletal and connective tissue disorders musular weakness	2.5% 2/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	14.0% 6/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Nervous system disorders headache	2.5% 2/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	16.3% 7/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Nervous system disorders hemiparesis	5.0% 4/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	4.7% 2/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
Nervous system disorders partial seizure	6.2% 5/80 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.	2.3% 1/43 • 3 years Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.

Additional Information

Anthony Gringeri, Ph.D. Senior Vice President Strategic Resources

ImmunoCellular Therapeutics Ltd.

Phone: 818 264 2300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60