Phase 2
N=110
Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00199901 ↗Enrolled (actual)
110
Serious AEs
20.0%
Results posted
Apr 2021
Primary outcome: Primary: Rate of Relapse-free Survival at 18 Months — 29; 28; 27; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NY-ESO-1 ISCOMATRIX® (Biological); ISCOMATRIX® adjuvant (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ludwig Institute for Cancer Research
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Relapse-free Survival at 18 Months |
29; 28; 27; 26 | — |
| SECONDARY Number of Patients With Treatment -Emergent Adverse Events (TEAEs) |
54; 52; 10; 12; 2; 7 | — |
| SECONDARY Relapse-Free Survival During the Entire Period of Observation (up to 6 Years). |
23; 25; 33; 29 | — |
| SECONDARY Overall Survival |
32; 31; 24; 23 | — |
| SECONDARY 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 |
31; 32; 2; 0; 8; 10 | — |
| SECONDARY 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 |
0; 32; 0; 2; 2; 8 | — |
| SECONDARY 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 |
0; 20; 0; 0; 3; 7 | — |
| SECONDARY 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 |
0; 19; 1; 0; 3; 6 | — |
| SECONDARY 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 |
0; 26; 2; 2; 6; 4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00199901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.