TriangleNCT02650986 · STUDY IN CONTEXT
Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Will be assessed using Common Toxicity Criteria. Patients will be monitored by medical histories, physical examinations, ophthalmologic exams, and blood studies to detect potential toxicities from the treatment. the number of patients experiencing a DLT are reported.
Unfeasibility will be defined as 3 or more preparations not meeting the lot release criteria in each cohort. Sufficient numbers of circulating, lot released confirmed T cells will be measured prior to administration. The count of patients not meeting the preparation criteria are reported.
TCR and vector presence will be quantitated in PBMC samples, obtained before adoptive transfer and at weeks 1, 2, 4, 8, and 12 after transgenic cell adoptive transfer. Thereafter, sampling will be every 3 months during the first year, and then every 6 to 12 months per schedule of procedures and observations.
Will be assessed in blood by polymerase chain reaction (PCR).
Will be determined by immune-related Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Response assessment will be performed by comparing standard computed tomography imaging scans and photographs of target lesions from baseline.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- trial label
- Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- outcome key
- om-0000
- source section id
- NCT02650986-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Dose Limiting Toxicities
- endpoint definition
- Will be assessed using Common Toxicity Criteria. Patients will be monitored by medical histories, physical examinations, ophthalmologic exams, and blood studies to detect potential toxicities from the treatment. the number of patients experiencing a DLT are reported.
- time origin
- Up to 30 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- outcome key
- om-0001
- source section id
- NCT02650986-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Feasibility Concerns in Manufacturing of NY-ESO-1/ dnTGFbetaRII Engineered Cells
- endpoint definition
- Unfeasibility will be defined as 3 or more preparations not meeting the lot release criteria in each cohort. Sufficient numbers of circulating, lot released confirmed T cells will be measured prior to administration. The count of patients not meeting the preparation criteria are reported.
- time origin
- 1 month
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- outcome key
- om-0002
- source section id
- NCT02650986-om-0002
- source outcome index
- 2
- endpoint
- Expression of the NY-ESO-1 T Cell Receptor (TCR) Transgenic Protein in Peripheral Blood Mononuclear Cells (PBMC)
- endpoint definition
- TCR and vector presence will be quantitated in PBMC samples, obtained before adoptive transfer and at weeks 1, 2, 4, 8, and 12 after transgenic cell adoptive transfer. Thereafter, sampling will be every 3 months during the first year, and then every 6 to 12 months per schedule of procedures and observations.
- time origin
- Up to 15 years
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- outcome key
- om-0003
- source section id
- NCT02650986-om-0003
- source outcome index
- 3
- endpoint
- Replication Competent Retrovirus (RCR)
- endpoint definition
- Will be assessed in blood by polymerase chain reaction (PCR).
- time origin
- Up to 1 year
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- outcome key
- om-0004
- source section id
- NCT02650986-om-0004
- source outcome index
- 4
- endpoint
- Tumor Response (Complete and Partial Response)
- endpoint definition
- Will be determined by immune-related Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Response assessment will be performed by comparing standard computed tomography imaging scans and photographs of target lesions from baseline.
- time origin
- Up to 90 days after TCR transgenic PBMC adoptive transfer
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)
- regimen
- Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^7 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02650986-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)
- regimen
- Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^8 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02650986-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
- regimen
- Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^9 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02650986-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
- regimen
- Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^9 Decitabine: Given IV at 20 mg/m\^2 x 3 days Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02650986-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)
- regimen
- Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^7 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02650986-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)
- regimen
- Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^8 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02650986-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
- regimen
- Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^9 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02650986-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
- regimen
- Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^9 Decitabine: Given IV at 20 mg/m\^2 x 3 days Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02650986-om-0001#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- harm key
- EG000
- source section id
- NCT02650986-ae
- event group key
- EG000
- event group label
- Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- harm key
- EG001
- source section id
- NCT02650986-ae
- event group key
- EG001
- event group label
- Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)
- serious affected
- 3
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- harm key
- EG002
- source section id
- NCT02650986-ae
- event group key
- EG002
- event group label
- Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pathologic-stage-iiic-cutaneous-melanoma-ajcc-v8
- nct id
- NCT02650986
- harm key
- EG003
- source section id
- NCT02650986-ae
- event group key
- EG003
- event group label
- Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
- serious affected
- 3
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice