Trial Outcomes & Findings for Ipilimumab Administered to Stage IIIC Stage IV Melanoma After Reg. T Cell Depletion With Denileukin Diftitox (NCT NCT02009384)

Results Overview

no outcomes available, Study was Terminated due to low subject enrollment \[r/t requirement of prior treatment with denileukin diftitox\] Data was not analyzed

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

Results posted on

2021-10-25

Participant Flow

Study was Terminated due to low subject enrollment \[r/t requirement of prior treatment with denileukin diftitox\] Data was not analyzed

Study was Terminated

Participant milestones

Participant milestones
Measure	Ipilimumab IV ipilimumab Ipilimumab: administration of IV ipilimumab for up to 4 cycles Study was Terminated due to low subject enrollment \[r/t requirement of prior treatment with denileukin diftitox\] Data was not analyzed
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Ipilimumab IV ipilimumab Ipilimumab: administration of IV ipilimumab for up to 4 cycles Study was Terminated due to low subject enrollment \[r/t requirement of prior treatment with denileukin diftitox\] Data was not analyzed
Overall Study Death	2

Baseline Characteristics

Ipilimumab Administered to Stage IIIC Stage IV Melanoma After Reg. T Cell Depletion With Denileukin Diftitox

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ipilimumab n=2 Participants IV ipilimumab Ipilimumab: administration of IV ipilimumab for up to 4 cycles
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

Population: no outcomes available, Study was Terminated due to low subject enrollment \[r/t requirement of prior treatment with denileukin diftitox\] Data was not analyzed

no outcomes available, Study was Terminated due to low subject enrollment \[r/t requirement of prior treatment with denileukin diftitox\] Data was not analyzed

Outcome measures

Outcome data not reported

Adverse Events

Ipilimumab

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ipilimumab n=2 participants at risk dosage:3 mg/kg of subject weight dosage form: Intravenous administration on Ipilimumab frequency of administration: Ipilimumab: administration of IV ipilimumab every three weeks for up to 4 cycles
Nervous system disorders Grade: 3 Encephalopathy	50.0% 1/2 • Number of events 1 • All AEs During study treatment and 21 days following end of treatment will be documented and reported if applicable. Adverse events occurring between the time of signing informed consent to the date of the first dose will NOT be captured as AEs unless the AE is a direct result of a study-specific procedure or results in death from an event other than PD

Other adverse events

Adverse event data not reported

Additional Information

Jason Chesney

University of Louisville

Phone: 502-562-3429

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place