NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma

PHASE1TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

January 24, 2014

Primary Completion Date

May 17, 2016

Study Completion Date

May 17, 2016

Conditions
Unresectable or Metastatic Melanoma
Interventions
BIOLOGICAL

Ipilimumab

Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.

BIOLOGICAL

NY-ESO-1 Protein Vaccine

NY-ESO-1 recombinant protein (250 µg) was mixed with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.

BIOLOGICAL

NY-ESO-1 OLP4 Vaccine with Poly-ICLC and Montanide

NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.

BIOLOGICAL

NY-ESO-1 OLP4 Vaccine with Poly-ICLC

NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.

Trial Locations (5)

10029

Mount Sinai Medical Center, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

15213

University of Pittsburgh Cancer Center, Pittsburgh

22908

University of Virginia Cancer Center, Charlottesville

Unknown

Austin Health, Ludwig Oncology Unit, Melbourne

All Listed Sponsors
collaborator

Cancer Research Institute, NY, USA

UNKNOWN

lead

Ludwig Institute for Cancer Research

OTHER