18 and older, female only, with Fallopian Tube Cancer or Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients With Dose Limiting Toxicities (DLTs)Primary· up to 16 weeks
Toxicities and adverse events defined by National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999). DLT defined as:
≥ Grade 2 autoimmune phenomena, asymptomatic bronchospasm or generalized urticaria, or ≥ Grade 3 hematological and non hematological toxicities. To be dose-limiting, an adverse event must be definitely, probably, or possibly related to the administration of the investigational agent.
Group
Value
95% CI
NY-ESO-1b Peptide With Montanide® ISA-51
0
Number of Patients Developing NY-ESO-1 Antibodies After TreatmentSecondary· up to 16 weeks
Blood samples were obtained at baseline and in weeks 4, 7, 10, 13 and 16 for the assessment of NY-ESO-1 specific antibodies by enzyme-linked immunosorbent assay (ELISA).
Group
Value
95% CI
NY-ESO-1b Peptide With Montanide® ISA-51
2
NY-ESO-1b Peptide With Montanide® ISA-51
7
Number of Patients With NY-ESO-1b-Specific CD8+ T Cells Measured by Tetramer AnalysisSecondary· up to 16 weeks.
Blood samples were obtained at baseline and at 4, 7, 10. 13 and 16 weeks. Tetramer assays were conducted after presensitization of CD8+ T cells with NY-ESO-1b. Results are presented separately for patients with NY-ESO-1 positive and negative tumors.
Patients with NY ESO-1 Positive Tumors
Group
Value
95% CI
NY-ESO-1b Peptide With Montanide® ISA-51
3
NY-ESO-1b Peptide With Montanide® ISA-51
1
Patients with NY-ESO-1 Negative Tumors
Group
Value
95% CI
NY-ESO-1b Peptide With Montanide® ISA-51
3
NY-ESO-1b Peptide With Montanide® ISA-51
2
Number of Patients With NY-ESO-1b-Specific Activated CD8+ T Cells Measured by ELISPOTSecondary· up to 16 weeks
Blood samples were obtained at baseline and at 4, 7, 10, 13 and 16 weeks. T cell responses were monitored after the in vitro sensitization with NY-ESO-1b (157-165), modified NY-ESO-1b-A (157-165A), or control peptide influenza matrix 58 to 66. Results are presented separately for patients with NY-ESO-1 positive and negative tumors.
Patients with NY-ESO-1 Positive Tumors
Group
Value
95% CI
NY-ESO-1b Peptide With Montanide® ISA-51
3
NY-ESO-1b Peptide With Montanide® ISA-51
1
Patients with NY-ESO-1 Negative Tumors
Group
Value
95% CI
NY-ESO-1b Peptide With Montanide® ISA-51
3
NY-ESO-1b Peptide With Montanide® ISA-51
2
Number of Patients With NY-ESO-1b-specific Delayed-type Hypersensitivity (DTH)Secondary· up to 16 weeks
NY-ESO-1b-specific delayed-type hypersensitivity (DTH) was measured by number of patients with induration and/or redness at each timepoint.
NY-ESO-1b-specific DTH skin reaction was measured at baseline and weeks 7 and 16. The NY-ESO-1b peptide solution (0.1 mg/mL in 8% DMSO) was injected intradermally at a separate site from the vaccination to give a visable and palpable skin depot. The extent and intensity of DTH reactions were documented by measuring visible redness, palpable induration and other signs of local skin irritation or necrosis. Assessment of DTH reaction was performed 48 hours a
Group
Value
95% CI
NY-ESO-1b Peptide With Montanide® ISA-51
0
NY-ESO-1b Peptide With Montanide® ISA-51
9
Clinical Outcome as Measured by Number of Patients With No Evidence of Disease and Number of Participants Who ProgressedSecondary· up to 52 months
Although clinical outcome was not an endpoint of this study, patients were evaluated for disease progression throughout the study by cancer antigen 125 (CA-125) levels, physical examination and at the time of study completion with CT scan. All patients enrolled in the study were confirmed to be in Complete Response (cCR) at the initiation of therapy, as documented by CA-125 at \<35 units/mL, physical examination, and CT scan without evidence of disease. Patients were assessed for disease progression by CA-125 during the study at weeks 7 and 16. CT scan was done after completion of the study (w
Week 16 (End of Study)
Group
Value
95% CI
NY-ESO-1b Peptide With Montanide® ISA-51
7
NY-ESO-1b Peptide With Montanide® ISA-51
2
Month 52 (last follow-up)
Group
Value
95% CI
NY-ESO-1b Peptide With Montanide® ISA-51
3
NY-ESO-1b Peptide With Montanide® ISA-51
6
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 16 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: A phase I trial to study the side effects of vaccine therapy in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07402915 — Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian
· Phase 1
· recruiting
NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo
· Phase 3
· recruiting
NCT06787612 — Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
· Phase 2
· recruiting
NCT07023484 — Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer
· Phase 2
· recruiting
NCT07460180 — The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cy
· Phase 1, PHASE2
· recruiting
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NCT02643303 — A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers
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· Phase 1
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ludwig Institute for Cancer Research
Last refreshed: 4 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00066729.