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MelanomaPhase 2NCT00199901

Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma

A Phase 2 study testing NY-ESO-1 ISCOMATRIX® and ISCOMATRIX® adjuvant in people with Melanoma, run by Ludwig Institute for Cancer Research at 15 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
NY-ESO-1 ISCOMATRIX® and ISCOMATRIX® adjuvant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
111 participants
Where
15 sitesin 3 countries
Study dates
Sep 2005to Dec 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)
Show all 9Show fewer
  • Age 18 years or older.
  • Able to give written informed consent.
  • Vital laboratory parameters within normal range, or protocol specified ranges.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

15 sites in 3 countries.

15 sites in 3 countries

United Kingdom8 sites

  • University Hospital - Birmingham

    Birmingham, B29 6JD

  • Addenbrooke's Hospital

    Cambridge, CB2 2QQ

  • Western Infirmary

    Glasgow, G11 6NT

  • St Georges Hospital

    London, SW17 0RE

  • Royal Marsden Hospital

    London, SW3 6JJ

  • Mount Vernon Hospital

    Northwood, HA6 2RN

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • Southampton University Hospitals

    Southampton, SO16 6YD

Other trials in United Kingdom

Australia6 sites

  • Sydney Melanoma Unit - Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • Austin Health (Ludwig Institute Oncology Unit)

    Heidelberg, Victoria, 3084

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Newcastle Melanoma Unit - Newcastle Mater Misericordiae Hospital

    Newcastle, New South Wales, 2298

  • Mater Medical Centre, Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

New Zealand1 site

  • University of Auckland (Waitemata DHB)

    Auckland

Other trials in New Zealand

About this study

Official title: Randomized, Double-blind Phase II Trial of NY-ESO-1 ISCOMATRIX® Vaccine and ISCOMATRIX® Adjuvant Alone in Patients With Resected Stage Ilc, Illb, lIIc, or IV Malignant Melanoma

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.

Read the detailed description

NY-ESO-1 protein is an immune target found in many cancers including melanoma. ISCOMATRIX® adjuvant enhances immune responses. This trial compares NY-ESO-1 ISCOMATRIX® vaccine with ISCOMATRIX® adjuvant alone to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for participants with Malignant Melanoma which has been removed, but is at high risk of recurrence.

Eligible participants are randomly allocated to a treatment arm. Treatment involves four intramuscular (into a muscle) injections (1 injection every 4 weeks x 3, plus 1 injection at 6 months).

Participants are assessed for recurrence of melanoma, safety and immune responses (by blood test) over the 18 month study period. Off study, their own doctor will follow them for melanoma recurrence and survival.

Conditions
Melanoma
Being tested
NY-ESO-1 ISCOMATRIX®, ISCOMATRIX® adjuvant
Keywords
Phase II, Randomized Controlled Trial, Double-Blind, Cancer Vaccine, NY-ESO-1 protein, human, ISCOMATRIX®, immunological adjuvant
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

  • 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).

Study groups in NCT00199901
Study groupRoleWhat they receive
VaccineActive comparatorNY-ESO-1 ISCOMATRIX® vaccine
Receives: Biological: NY-ESO-1 ISCOMATRIX®
Adjuvant AlonePlacebo comparatorISCOMATRIX® adjuvant alone
Receives: Biological: ISCOMATRIX® adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 18 months

Secondary outcomes (8)

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

    Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, electrocardiograms, magnetic resonance imaging, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 18 months. AEs were considered to be treatment emergent (TEAE) if they occurred or worsened in severity after the first dose of study treatment.

    Measured: 18 months

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

    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.

    Measured: through study completion; up to 6 years

  3. Overall Survival

    Overall Survival measured during the entire Period of Observation (up to 6years).

    Overall survival was measured from start of treatment to the last follow-up or death.

    Measured: through study completion; up to 6 years

  4. 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

    NY-ESO-1-specific antibodies were measured by an enzyme-linked immunosorbent assay ( ELISA) method at baseline and on days 71, 197, 365 and end of study. The results are reported as antibodies to NY-ESO-1-specific Total IgG (reciprocal titer) and were scored on a scale of 0-4 with 0 being no or minimal antibody response (reciprocal titer of 0-100) and 4 a strong antibody response (reciprocal titer of >100,000). The number of patients with each antibody response level are tabulated at each timepoint.

    Measured: Baseline

  5. 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

    NY-ESO-1-specific antibodies were measured by an enzyme-linked immunosorbent assay ( ELISA) method at baseline and on days 71, 197, 365 and end of study. The results are reported as antibodies to NY-ESO-1-specific Total IgG (reciprocal titer) and were scored on a scale of 0-4 with 0 being no or minimal antibody response (reciprocal titer of 0-100) and 4 a strong antibody response (reciprocal titer of >100,000). The number of patients with each antibody response level are tabulated at each timepoint.

    Measured: Day 71

  6. NY-ESO-1 Antibody Response on Day 197 Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response

    NY-ESO-1-specific antibodies were measured by an enzyme-linked immunosorbent assay ( ELISA) method at baseline and on days 71, 197, 365 and end of study. The results are reported as antibodies to NY-ESO-1-specific Total IgG (reciprocal titer) and were scored on a scale of 0-4 with 0 being no or minimal antibody response (reciprocal titer of 0-100) and 4 a strong antibody response (reciprocal titer of >100,000). The number of patients with each antibody response level are tabulated at each timepoint.

    Measured: Day 197

  7. NY-ESO-1 Antibody Response on Day 365 Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response

    NY-ESO-1-specific antibodies were measured by an enzyme-linked immunosorbent assay ( ELISA) method at baseline and on days 71, 197, 365 and end of study. The results are reported as antibodies to NY-ESO-1-specific Total IgG (reciprocal titer) and were scored on a scale of 0-4 with 0 being no or minimal antibody response (reciprocal titer of 0-100) and 4 a strong antibody response (reciprocal titer of >100,000). The number of patients with each antibody response level are tabulated at each timepoint.

    Measured: Day 365

  8. NY-ESO-1 Antibody Response at End of Study Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response

    NY-ESO-1-specific antibodies were measured by an enzyme-linked immunosorbent assay ( ELISA) method at baseline and on days 71, 197, 365 and end of study. The results are reported as antibodies to NY-ESO-1-specific Total IgG (reciprocal titer) and were scored on a scale of 0-4 with 0 being no or minimal antibody response (reciprocal titer of 0-100) and 4 a strong antibody response (reciprocal titer of >100,000). The number of patients with each antibody response level are tabulated at each timepoint.

    Measured: End of Study (month 18)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionDec 2008
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00199901
Sponsor's protocol ID
LUD2003-009
Status last verified
Oct 2022
First submitted
16 Sep 2005
Last updated
12 Oct 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NY-ESO-1 ISCOMATRIX® and ISCOMATRIX® adjuvant in people with Melanoma, run by Ludwig Institute for Cancer Research at 15 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United Kingdom, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Relapse-free Survival at 18 Months (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00199901.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.

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