TriangleNCT02858310 · STUDY IN CONTEXT
E7 TCR T Cells for Human Papillomavirus-Associated Cancers
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
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Compete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Adverse events were assessed by the Common Terminology Criteria for Adverse Events v4.0. Grade 3 is serious. Grade 4 is life-threatening. Grade 5 is death related to adverse event. A DLT is defined as all Grade 3 and greater toxicities occurring within 30 days of the cell infusion with the exception of: Cytokine Release Syndrome (CRS) that resolves ≤ grade 2 within 14 days of the last dose of aldesleukin. Autoimmune toxicity that resolves to ≤ grade 2 within 14 days for starting symptom treatment (e.g. steroids). Cardiac, gastrointestinal, dermatological, hepatic, pulmonary, renal, hematologic, neurologic toxicity, or toxicity in Appendix C of the protocol attributable to aldesleukin that resolves to ≤ grade 2 within 14 days of the last dose of aldesleukin. Transient grade 3 hypoxia associated with cell infusion that corrects to ≤ grade 2 with supplemental oxygen and/or that resolves to ≤ grade 2 within 24 hours or before starting aldesleukin.
Progression-free survival is the time from start of treatment to disease progression or death from any cause. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Disease progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
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-vulvar-cancer
- nct id
- NCT02858310
- trial label
- E7 TCR T Cells for Human Papillomavirus-Associated Cancers
- 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
- 4
- harms Count
- 5
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0003
- source section id
- NCT02858310-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
- endpoint definition
- Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
- time origin
- Adverse Events were monitored/assessed from the first study intervention, Study Day 0, through 40 days after the study therapy was last administered up to a maximum of 12 months
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 194/224 participants enrolled but not treated were not evaluable for this outcome.
- 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-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0000
- source section id
- NCT02858310-om-0000
- source outcome index
- 0
- endpoint
- Phase II: Overall Response Rate Partial Response + Complete Response (PR +CR)
- endpoint definition
- Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Compete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
- time origin
- At 12 weeks, every 3 months x 3, and every 6 months for approximately 5 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants in Phase II only were evaluable for this outcome.
- 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-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0001
- source section id
- NCT02858310-om-0001
- source outcome index
- 1
- endpoint
- Phase I: Number of Dose Limiting Toxicities (DLT)
- endpoint definition
- Adverse events were assessed by the Common Terminology Criteria for Adverse Events v4.0. Grade 3 is serious. Grade 4 is life-threatening. Grade 5 is death related to adverse event. A DLT is defined as all Grade 3 and greater toxicities occurring within 30 days of the cell infusion with the exception of: Cytokine Release Syndrome (CRS) that resolves ≤ grade 2 within 14 days of the last dose of aldesleukin. Autoimmune toxicity that resolves to ≤ grade 2 within 14 days for starting symptom treatment (e.g. steroids). Cardiac, gastrointestinal, dermatological, hepatic, pulmonary, renal, hematologic, neurologic toxicity, or toxicity in Appendix C of the protocol attributable to aldesleukin that resolves to ≤ grade 2 within 14 days of the last dose of aldesleukin. Transient grade 3 hypoxia associated with cell infusion that corrects to ≤ grade 2 with supplemental oxygen and/or that resolves to ≤ grade 2 within 24 hours or before starting aldesleukin.
- time origin
- From the day of cell infusion (Day 0) to Day +30
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 194/224 participants enrolled but not treated were not evaluable.
- 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-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0002
- source section id
- NCT02858310-om-0002
- source outcome index
- 2
- endpoint
- Progression-free Survival
- endpoint definition
- Progression-free survival is the time from start of treatment to disease progression or death from any cause. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Disease progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
- time origin
- From the time of cell infusion (Day 0) until documented progressive disease; a maximum of 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 24/224 participants were analyzed because 200 were not evaluable for this outcome.
- 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-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells
- regimen
- Phase II Cohort; Arm 2: Phase II; 1 x 10\^11 E7 Cells that were determined in Phase I + Aldesleukin.
- analyzed count
- 18
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02858310-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells
- regimen
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 1: 1 x 10\^9 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02858310-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells
- regimen
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 2: 1 x 10\^10 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02858310-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells
- regimen
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 3: 1 x 10\^11 E7 Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 T-Cell Receptor (TCR) Cells at escalating doses, followed by Aldesleukin.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02858310-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells
- regimen
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 1: 1 x 10\^9 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02858310-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells
- regimen
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 2: 1 x 10\^10 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02858310-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells
- regimen
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 3: 1 x 10\^11 E7 Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 T-Cell Receptor (TCR) Cells at escalating doses, followed by Aldesleukin.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02858310-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells
- regimen
- Phase II Cohort; Arm 2: Phase II; 1 x 10\^11 E7 Cells that were determined in Phase I + Aldesleukin.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02858310-om-0002#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0002
- arm key
- OG004
- arm label
- Participants Enrolled But Were Not Treated
- regimen
- Participants were enrolled but were not treated and not assigned to Arm/Cohorts.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02858310-om-0002#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells
- regimen
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 1: 1 x 10\^9 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02858310-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells
- regimen
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 2: 1 x 10\^10 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02858310-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT02858310
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells
- regimen
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 3: 1 x 10\^11 E7 Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 T-Cell Receptor (TCR) Cells at escalating doses, followed by Aldesleukin.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02858310-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT02858310
- harm key
- EG000
- source section id
- NCT02858310-ae
- event group key
- EG000
- event group label
- Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells
- serious affected
- 3
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- All-Cause Mortality was monitored/assessed from the time of consent for screening until participants were taken off study, a maximum of 1 year. Adverse Events (AEs) were monitored/assessed from the first study intervention, Study Day 0, through 40 days after the study therapy was last administered, a maximum of 12 months.
- event definition
- 194/224 participants(pts) were not treated/unevaluable for safety. AEs not reported for 5 pts (i.e., signed screening consent only/were not deemed eligible for treatment before death) on study who died. "Per Protocol, AEs were only assessed for pts that were treated (i.e., received at least one course of the study treatment). Deaths were assessed for all randomized pts who were considered enrolled. All study related AEs were captured in the study database up to 40 days after last study agent."
- 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-vulvar-cancer
- nct id
- NCT02858310
- harm key
- EG001
- source section id
- NCT02858310-ae
- event group key
- EG001
- event group label
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells
- serious affected
- 3
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- All-Cause Mortality was monitored/assessed from the time of consent for screening until participants were taken off study, a maximum of 1 year. Adverse Events (AEs) were monitored/assessed from the first study intervention, Study Day 0, through 40 days after the study therapy was last administered, a maximum of 12 months.
- event definition
- 194/224 participants(pts) were not treated/unevaluable for safety. AEs not reported for 5 pts (i.e., signed screening consent only/were not deemed eligible for treatment before death) on study who died. "Per Protocol, AEs were only assessed for pts that were treated (i.e., received at least one course of the study treatment). Deaths were assessed for all randomized pts who were considered enrolled. All study related AEs were captured in the study database up to 40 days after last study agent."
- 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-vulvar-cancer
- nct id
- NCT02858310
- harm key
- EG002
- source section id
- NCT02858310-ae
- event group key
- EG002
- event group label
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells
- serious affected
- 5
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- All-Cause Mortality was monitored/assessed from the time of consent for screening until participants were taken off study, a maximum of 1 year. Adverse Events (AEs) were monitored/assessed from the first study intervention, Study Day 0, through 40 days after the study therapy was last administered, a maximum of 12 months.
- event definition
- 194/224 participants(pts) were not treated/unevaluable for safety. AEs not reported for 5 pts (i.e., signed screening consent only/were not deemed eligible for treatment before death) on study who died. "Per Protocol, AEs were only assessed for pts that were treated (i.e., received at least one course of the study treatment). Deaths were assessed for all randomized pts who were considered enrolled. All study related AEs were captured in the study database up to 40 days after last study agent."
- 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-vulvar-cancer
- nct id
- NCT02858310
- harm key
- EG003
- source section id
- NCT02858310-ae
- event group key
- EG003
- event group label
- Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells
- serious affected
- 5
- serious at risk
- 18
- other affected
- 18
- other at risk
- 18
- frequency threshold
- 0
- collection period
- All-Cause Mortality was monitored/assessed from the time of consent for screening until participants were taken off study, a maximum of 1 year. Adverse Events (AEs) were monitored/assessed from the first study intervention, Study Day 0, through 40 days after the study therapy was last administered, a maximum of 12 months.
- event definition
- 194/224 participants(pts) were not treated/unevaluable for safety. AEs not reported for 5 pts (i.e., signed screening consent only/were not deemed eligible for treatment before death) on study who died. "Per Protocol, AEs were only assessed for pts that were treated (i.e., received at least one course of the study treatment). Deaths were assessed for all randomized pts who were considered enrolled. All study related AEs were captured in the study database up to 40 days after last study agent."
- 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-vulvar-cancer
- nct id
- NCT02858310
- harm key
- EG004
- source section id
- NCT02858310-ae
- event group key
- EG004
- event group label
- Participants Enrolled But Were Not Treated
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- All-Cause Mortality was monitored/assessed from the time of consent for screening until participants were taken off study, a maximum of 1 year. Adverse Events (AEs) were monitored/assessed from the first study intervention, Study Day 0, through 40 days after the study therapy was last administered, a maximum of 12 months.
- event definition
- 194/224 participants(pts) were not treated/unevaluable for safety. AEs not reported for 5 pts (i.e., signed screening consent only/were not deemed eligible for treatment before death) on study who died. "Per Protocol, AEs were only assessed for pts that were treated (i.e., received at least one course of the study treatment). Deaths were assessed for all randomized pts who were considered enrolled. All study related AEs were captured in the study database up to 40 days after last study agent."
- 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