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

NCT01810016 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-10-12

Study results available
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Summary

This was a Phase 1, open-label, non-randomized study of the combination of NY-ESO-1 plus ipilimumab in patients with unresectable or metastatic melanoma for whom treatment with ipilimumab was indicated. Patients must have had evidence of NY-ESO-1 or LAGE-1 tumor positivity and radiologically measurable disease by the immune-related Response Criteria (irRC). Primary study objectives were to determine the safety and tolerability of the combination and to evaluate humoral and cellular immune response. Secondary objectives were to evaluate tumor response and immunological changes in the tumor microenvironment.

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.

Sponsors & Collaborators

  • Cancer Research Institute, NY, USA

    collaborator UNKNOWN

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • Michael A Postow, MD · Memorial Sloan Kettering Cancer Center

  • Hassane M Zarour, MD · University of Pittsburgh

  • Craig L Slingluff, MD · University of Virginia

  • Jonathan Cebon, MBBS, FRACP, PhD · Austin Health, Ludwig Oncology Unit

  • Philip Friedlander, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-24
Primary Completion
2016-05-17
Completion
2016-05-17
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01810016 on ClinicalTrials.gov