Neoadjuvant Combination Therapy With Ipilimumab and HighDose IFN-α2b for Melanoma

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 21, 2013

Primary Completion Date

February 14, 2017

Study Completion Date

February 27, 2017

Conditions
Melanoma
Interventions
DRUG

administration of ipilimumab10mg/kg

"Ipilimumab IV infusion:~* Day 0 (within 1-2 weeks of baseline biopsy) every 3 weeks for 2 doses followed by definitive surgery~* After surgery recover-y resume at the same dose for 2 additional doses given 3 weeks apart~* Dose continued 12 weeks later for 4 additional doses given 12 weeks apart~Interferon Alfa-2b will be given concurrently with ipilimumab. Each patient will receive Interferon Alfa-2b at 20 MU/m²/day intravenously for 5 consecutive days out of 7 every week for 4 weeks, followed by 10 MU/m²/d subcutaneously every other day, 3 times each week for 2 weeks, followed by definitive surgery. After surgery recovery, Interferon Alfa-2b will be resumed at 10 MU/m²/d subcutaneously, every other day three times a week for 46 additional weeks."

DRUG

administration of ipilimumab 3mg/kg + HDI

"Ipilimumab IV infusion:~* Day 0 (within 1-2 weeks of baseline biopsy) every 3 weeks for 2 doses followed by definitive surgery~* After surgery recover-y resume at the same dose for 2 additional doses given 3 weeks apart~* Dose continued 12 weeks later for 4 additional doses given 12 weeks apart~Interferon Alfa-2b will be given concurrently with ipilimumab. Each patient will receive Interferon Alfa-2b at 20 MU/m²/day intravenously for 5 consecutive days out of 7 every week for 4 weeks, followed by 10 MU/m²/d subcutaneously every other day, 3 times each week for 2 weeks, followed by definitive surgery. After surgery recovery, Interferon Alfa-2b will be resumed at 10 MU/m²/d subcutaneously, every other day three times a week for 46 additional weeks."

Trial Locations (1)

15232

UPMC Hillman Cancer Center, Pittsburgh

All Listed Sponsors
lead

Diwakar Davar

OTHER

NCT01608594 - Neoadjuvant Combination Therapy With Ipilimumab and HighDose IFN-α2b for Melanoma | Biotech Hunter | Biotech Hunter