Trial Outcomes & Findings for A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients (NCT NCT02009397)

NCT ID: NCT02009397

Last Updated: 2021-11-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: assessed at baseline and at 4 weeks (±1 week) following the last administration of Ipilimumab
• Results posted on: 2021-11-22

Participant Flow

Participant milestones

Measure	Ipilimumab and GM-CSF IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles Ipilimumab GM-CSF
Overall Study STARTED	26
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Measure	Ipilimumab and GM-CSF IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles Ipilimumab GM-CSF
Overall Study Protocol Violation	6
Overall Study Death	8
Overall Study Lost to Follow-up	6

Baseline Characteristics

A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients

Baseline characteristics by cohort

Measure	Ipilimumab and GM-CSF n=26 Participants IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles Ipilimumab GM-CSF
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: assessed at baseline and at 4 weeks (±1 week) following the last administration of Ipilimumab

Outcome measures

Measure	Ipilimumab and GM-CSF n=20 Participants IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles Ipilimumab GM-CSF
Change in Immune-related Overall Response Rate (irORR)	20 participants

Adverse Events

Ipilimumab and GM-CSF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jason Chesney

University of Louisville, James Graham Brown Cancer Center

Phone: 502-562-3429

Email: jason.chesney@louisville.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place