# Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1

> **NCT02650986** · PHASE1,PHASE2 · ACTIVE_NOT_RECRUITING · sponsor: **Roswell Park Cancer Institute** · enrollment: 15 (actual)

## Conditions studied

- Advanced Fallopian Tube Carcinoma
- Advanced Malignant Solid Neoplasm
- Advanced Melanoma
- Advanced Ovarian Carcinoma
- Advanced Primary Peritoneal Carcinoma
- Advanced Synovial Sarcoma
- Clinical Stage III Cutaneous Melanoma AJCC v8
- Clinical Stage IV Cutaneous Melanoma AJCC v8
- Metastatic Fallopian Tube Carcinoma
- Metastatic Melanoma
- Metastatic Ovarian Carcinoma
- Metastatic Primary Peritoneal Carcinoma
- Metastatic Synovial Sarcoma
- Pathologic Stage III Cutaneous Melanoma AJCC v8
- Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
- Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
- Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
- Pathologic Stage IIID Cutaneous Melanoma AJCC v8
- Pathologic Stage IV Cutaneous Melanoma AJCC v8
- Platinum-Resistant Fallopian Tube Carcinoma
- Platinum-Resistant Ovarian Carcinoma
- Platinum-Resistant Primary Peritoneal Carcinoma
- Stage III Fallopian Tube Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage III Primary Peritoneal Cancer AJCC v8
- Stage IIIA Fallopian Tube Cancer AJCC v8
- Stage IIIA Ovarian Cancer AJCC v8
- Stage IIIA Primary Peritoneal Cancer AJCC v8
- Stage IIIA1 Fallopian Tube Cancer AJCC v8
- Stage IIIA1 Ovarian Cancer AJCC v8
- Stage IIIA2 Fallopian Tube Cancer AJCC v8
- Stage IIIA2 Ovarian Cancer AJCC v8
- Stage IIIB Fallopian Tube Cancer AJCC v8
- Stage IIIB Ovarian Cancer AJCC v8
- Stage IIIB Primary Peritoneal Cancer AJCC v8
- Stage IIIC Fallopian Tube Cancer AJCC v8
- Stage IIIC Ovarian Cancer AJCC v8
- Stage IIIC Primary Peritoneal Cancer AJCC v8
- Stage IV Fallopian Tube Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Stage IV Primary Peritoneal Cancer AJCC v8
- Stage IVA Fallopian Tube Cancer AJCC v8
- Stage IVA Ovarian Cancer AJCC v8
- Stage IVA Primary Peritoneal Cancer AJCC v8
- Stage IVB Fallopian Tube Cancer AJCC v8
- Stage IVB Ovarian Cancer AJCC v8
- Stage IVB Primary Peritoneal Cancer AJCC v8
- Unresectable Melanoma
- Unresectable Ovarian Carcinoma
- Unresectable Synovial Sarcoma

## Interventions

- **DRUG:** Cyclophosphamide
- **DRUG:** Decitabine
- **OTHER:** Laboratory Biomarker Analysis
- **PROCEDURE:** Leukapheresis
- **BIOLOGICAL:** TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes

## Key facts

- **NCT ID:** NCT02650986
- **Lead sponsor:** Roswell Park Cancer Institute
- **Sponsor class:** OTHER
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2017-07-14
- **Primary completion:** 2021-03-04
- **Final completion:** 2032-07-14
- **Target enrollment:** 15 (ACTUAL)
- **Last updated:** 2025-06-17

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02650986

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02650986, "Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT02650986. Licensed CC0.

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