Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02775292 | Gene-Modified T Cells, Vaccine Therapy, and Nivolumab in Treating Patients With Stage IV or Locally Advanced Solid Tumors Expressing NY-ESO-1 | PHASE1 | COMPLETED | 1 | — | — | Jan 3, 2017 | Apr 8, 2019 | Jul 30, 2025 | 1 | United States |
Simple descriptive statistics will be used to summarize toxicities observed after TCR transgenic cell infusion in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity and nadir or maximum values for the laboratory measures, time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.
| Arm | Type | Description |
|---|---|---|
| Treatment (NY-ESO-1 TCR transduced PBMC, vaccine, nivolumab) | EXPERIMENTAL | CONDITIONING REGIMEN: Patients receive cyclophosphamide IV over 1 hour on days -5 to -4 and fludarabine phosphate IV over 30 minutes on days -4 to -1. NY-ESO-1 TCR PBMC INFUSION: Patients receive NY-ESO-1 TCR PBMC IV on day 0. NIVOLUMAB: Patients receive nivolumab IV over 60 minutes on day 0 or 1. Treatment repeats every 2 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. NY-ESO-1(157-165) PEPTIDE PULSED DC: Patients receive NY-ESO-1(157-165) peptide pulsed DC ID on days 1, 14, and 28. LOW DOSE ALDESLEUKIN ADMINISTRATION: Patients receive aldesleukin SC BID for 7 days beginning on day 1 for a maximum of 14 doses. |
| Name | Type | Description |
|---|---|---|
| Aldesleukin | BIOLOGICAL | Given SC |
| Cyclophosphamide | DRUG | Given IV |
| Fludarabine Phosphate | DRUG | Given IV |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Nivolumab | BIOLOGICAL | Given IV |
| NY-ESO-1 Reactive TCR Retroviral Vector Transduced Autologous PBL | BIOLOGICAL | Given IV |
| NY-ESO-1(157-165) Peptide-pulsed Autologous Dendritic Cell Vaccine | BIOLOGICAL | Given ID |
| Positron Emission Tomography | PROCEDURE | Correlative studies |
Inclusion Criteria: * Stage IV or locally advanced histologically confirmed solid tumors for which no alternative therapies with proven survival advantage are available * At least 1 lesion amenable for outpatient biopsies; this should be a cutaneous or palpable metastatic site or a deeper site acce...