Gene-Modified T Cells, Vaccine Therapy, and Nivolumab in Treating Patients With Stage IV or Locally Advanced Solid Tumors Expressing NY-ESO-1

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT02775292
Phase
PHASE1
Status
Completed

Conditions

  • Adult Solid Neoplasm
  • Childhood Solid Neoplasm
  • Metastatic Neoplasm

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

This phase I trial studies the side effects and the best dose of nivolumab when given together with gene-modified T cells and vaccine therapy in treating patients with solid tumors that express the cancer-testes antigen NY-ESO-1 gene AND have spread from where it started to nearby tissue or lymph nodes (locally advanced) or distant organs (stage IV). T cells are a special type of white blood cells (immune cell) that have the ability to kill cancer cells. Nivolumab may block PD-1 which is found on T cells and help the immune system kill cancer cells. Placing a modified gene for the NY-ESO-1 T cell receptor (TCR) into the patients' T cells in the laboratory and then giving them back to the patient may help the body build an immune response to kill tumor cells that express NY-ESO-1. Dendritic cells are another type of blood cell that can teach other cells in the body to look for cancer cells and attack them. Giving a dendritic cell vaccine with the NY-ESO-1 protein may help dendritic cells teach the immune system to target cancer cells expressing that protein, and further help the T cells attack cancer. Giving nivolumab together with gene-modified T-cells and dendritic cell vaccine may teach the immune system to recognize and kill cancer cells that express NY-ESO-1.

Key Dates

Start date
Jan 3, 2017
Status verified
Aug 2019
Primary completion
Apr 8, 2019
Completion
Apr 8, 2019

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (NY-ESO-1 TCR transduced PBMC, vaccine, nivolumab)
    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.

Primary Outcome Measure

Incidence of adverse events, defined following the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 15 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-

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UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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