NCT00199901

Brief Summary

The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for people with Malignant Melanoma which has been removed, but is at high risk of relapse.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_2

Geographic Reach
3 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
9.4 years until next milestone

Results Posted

Study results publicly available

April 8, 2021

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

3.3 years

First QC Date

September 16, 2005

Results QC Date

March 11, 2021

Last Update Submit

October 3, 2022

Conditions

Melanoma

Keywords

Phase IIRandomized Controlled TrialDouble-BlindCancer VaccineNY-ESO-1 protein, humanISCOMATRIX®, immunological adjuvant

Outcome Measures

Primary Outcomes (1)

  • Rate of Relapse-free Survival at 18 Months

    The number of patients who were alive and relapse free 18 months after starting therapy and the number of patients who relapsed or died within 18 months of starting therapy. Disease was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) as measured by CT. Disease progression or relapse was based on an increase of 20% or more in the sum of the longest diameter of target lesions, the appearance of any new lesion as confirmed by CT scan or death.

    18 months

Secondary Outcomes (8)

  • Number of Patients With Treatment -Emergent Adverse Events (TEAEs)

    18 months

  • Relapse-Free Survival During the Entire Period of Observation (up to 6 Years).

    through study completion; up to 6 years

  • Overall Survival

    through study completion; up to 6 years

  • NY-ESO-1 Antibody Response at Baseline Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response

    Baseline

  • NY-ESO-1 Antibody Response on Day 71 Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response

    Day 71

  • +3 more secondary outcomes

Study Arms (2)

Vaccine

ACTIVE COMPARATOR

NY-ESO-1 ISCOMATRIX® vaccine

Biological: NY-ESO-1 ISCOMATRIX®

Adjuvant Alone

PLACEBO COMPARATOR

ISCOMATRIX® adjuvant alone

Biological: ISCOMATRIX® adjuvant

Interventions

NY-ESO-1 ISCOMATRIX®BIOLOGICAL

100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant. Each patient will receive four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).

Vaccine
ISCOMATRIX® adjuvantBIOLOGICAL

120 μg of ISCOMATRIX® adjuvant Each patient will receive four intramuscular injections of ISCOMATRIX® adjuvant alone. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).

Adjuvant Alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven malignant melanoma.
  • Tumor expression of NY-ESO-1 antigen by immunohistochemistry.
  • Fully resected AJCC stage IIc, IIIb, IIIc or IV melanoma.
  • Within six months of surgery for melanoma.
  • Full recovery from surgery.
  • No immunotherapy or systemic adjuvant therapy for melanoma since most recent relapse and/or resection. (Previous adjuvant therapy accepted providing patient relapsed and resected after this.)
  • Age 18 years or older.
  • Able to give written informed consent.
  • Vital laboratory parameters within normal range, or protocol specified ranges.

You may not qualify if:

  • Other serious or significant illnesses.
  • Resected cerebral metastases.
  • Ocular melanoma.
  • Other malignancy within last 3 years, except for treated non-melanoma skin cancer and cervical cancer in situ.
  • Using immunosuppressive drugs.
  • Anticoagulation.
  • Known HIV positivity.
  • Chemotherapy or radiation therapy in last four weeks (6 weeks for nitrosourea drugs).
  • Not available for immunological and clinical follow-up assessments.
  • Participation in prior clinical trial involving an investigational agent within last 4 weeks.
  • Previous isolated limb perfusion (ILP).
  • Pregnancy or breastfeeding.
  • Refusal or inability to use effective means of contraception for women of childbearing potential.
  • Mental impairment that may compromise ability to give informed consent and to comply with study requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Sydney Melanoma Unit - Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Newcastle Melanoma Unit - Newcastle Mater Misericordiae Hospital

Newcastle, New South Wales, 2298, Australia

Location

Mater Medical Centre, Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

Austin Health (Ludwig Institute Oncology Unit)

Heidelberg, Victoria, 3084, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

University of Auckland (Waitemata DHB)

Auckland, New Zealand

Location

University Hospital - Birmingham

Birmingham, B29 6JD, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB2 2QQ, United Kingdom

Location

Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

St Georges Hospital

London, SW17 0RE, United Kingdom

Location

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

Mount Vernon Hospital

Northwood, HA6 2RN, United Kingdom

Location

Weston Park Hospital

Sheffield, S10 2SJ, United Kingdom

Location

Southampton University Hospitals

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Jonathan Skipper PhD
Organization
Ludwig Institute for Cancer Research
jskipper@lcr.org
(212) 450-1539

Study Officials

  • Prof. Jonathan S Cebon, MBBS PhD

    Ludwig Institute for Cancer Research

    STUDY CHAIR

  • Prof. Martin Gore, MBBS PhD

    The Royal Marsden Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2011

Last Updated

October 12, 2022

Results First Posted

April 8, 2021

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(8)NZ(1)AU(6)