Trial · NCT02280811
T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers
NCT02280811, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-08-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers. Trials, record NCT02280811. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02280811
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers
- NCT number
- NCT02280811
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Vaginal Cancer, Cervical Cancer, Anal Cancer, Penile Cancer, Oropharyngeal Cancer
- Interventions
- Fludarabine, Cyclophosphamide, E6 TCR, Aldesleukin
- First posted
- 2014-11-03
- Last updated
- 2017-09-06
- Results first posted
- 2017-08-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) | participants were followed for the duration of hospital stay, an average of 3 weeks | The MTD is the highest dose at which ≤1 of 6 patients experienced a dose limiting toxicity (DLT) or the highest dose level studied if DLTs are not observed at any of the dose levels. |
| Primary | Objective Tumor Response Rate (Complete or Partial Response) | 4 years | Objective tumor response rate is defined as the number of participants with a complete or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. |
| Primary | Duration of Response | up to one year | Duration of response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progression is at least a 20% increase in the sum of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events | 19 months and 7 days | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). 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. |
| Secondary | Number of Participants With a Dose Limiting Toxicity (DLT) | 19 months and 7 days | A dose limiting toxicity is all Grade 3 and greater toxicities with the exception of myelosuppression, defined as lymphopenia, neutropenia, decreased hemoglobin, and thrombocytopenia, due to chemotherapy preparative regimen. Aldesleukin expected toxicities as defined in Appendix 2 and 3 of the protocol. Expected chemotherapy toxicities as defined in the pharmaceutical information section. Immediate hypersensitivity reactions (excluding symptomatic bronchospasm and grade 4 hypotension) occurring within 2 hours of cell infusion (related to cell infusion) that are reversible to a grade 2 or less within 24 hours of cell administration with standard therapy. Grade 3 fever. Events that are clearly related to the patient's disease. |
| Secondary | Percentage of Cluster of Differentiation 3 (CD3+) Cells That Are E6 T-Cell Receptor Memory of Circulating T-Cells in Responders and Non-responders | One month after treatment | Detection of E6 TCR T cells in patients peripheral blood leukocytes (PBL)/apheresis samples by flow cytometry. |
| Secondary | Expression of Programmed Cell Death 1 (PD-1) by Circulating E6 T-Cell Receptor (TCR) T-Cells | one month after treatment | Presence of PD-1 on circulating lymphocytes by flow cytometry one month after treatment. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) | participants were followed for the duration of hospital stay, an average of 3 weeks | # of cells x 10^11 | NUMBER | |
| PRIMARY | Objective Tumor Response Rate (Complete or Partial Response) | 4 years | participants | NUMBER | |
| PRIMARY | Duration of Response | up to one year | months | MEAN | |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events | 19 months and 7 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Dose Limiting Toxicity (DLT) | 19 months and 7 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Cluster of Differentiation 3 (CD3+) Cells That Are E6 T-Cell Receptor Memory of Circulating T-Cells in Responders and Non-responders | One month after treatment | One patient in group HPV-16 E6 mTCR PBL 1x10\^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point. | percentage of cells | MEAN |
| SECONDARY | Expression of Programmed Cell Death 1 (PD-1) by Circulating E6 T-Cell Receptor (TCR) T-Cells | one month after treatment | One patient in group HPV-16 E6 mTCR PBL 1x10\^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point. | % PD-1 circulating lymphocytes | MEAN |
Source ClinicalTrials.gov
Results by group41
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) | All Treated Subjects | 2 | # of cells x 10^11 | ||
| Objective Tumor Response Rate (Complete or Partial Response) | HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | Complete Response (CR) | 0 | participants | |
| Objective Tumor Response Rate (Complete or Partial Response) | HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | Complete Response (CR) | 0 | participants | |
| Objective Tumor Response Rate (Complete or Partial Response) | HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | Complete Response (CR) | 0 | participants | |
| Objective Tumor Response Rate (Complete or Partial Response) | HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | Complete Response (CR) | 0 | participants | |
| Objective Tumor Response Rate (Complete or Partial Response) | HPV-16 E6 mTCR PBL MTD + HD IL-2 | Complete Response (CR) | 0 | participants | |
| Objective Tumor Response Rate (Complete or Partial Response) | HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | Partial Response (PR) | 0 | participants | |
| Objective Tumor Response Rate (Complete or Partial Response) | HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | Partial Response (PR) | 0 | participants | |
| Objective Tumor Response Rate (Complete or Partial Response) | HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | Partial Response (PR) | 0 | participants | |
| Objective Tumor Response Rate (Complete or Partial Response) | HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | Partial Response (PR) | 2 | participants |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Drug Administration | STARTED | HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 1 | |
| Drug Administration | STARTED | HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 2 | |
| Drug Administration | STARTED | HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 1 | |
| Drug Administration | STARTED | HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 6 | |
| Drug Administration | STARTED | HPV-16 E6 mTCR PBL MTD + HD IL-2 | 2 | |
| Drug Administration | COMPLETED | HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 1 | |
| Drug Administration | COMPLETED | HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 2 | |
| Drug Administration | COMPLETED | HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 1 | |
| Drug Administration | COMPLETED | HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 6 | |
| Drug Administration | COMPLETED | HPV-16 E6 mTCR PBL MTD + HD IL-2 | 2 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events162
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 1 | 1 | 1 |
| other | Fatigue | General disorders | HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 1 | 2 | 1 |
| other | Fatigue | General disorders | HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 1 | 1 | 1 |
| other | Fatigue | General disorders | HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 1 | 6 | 1 |
| other | Fatigue | General disorders | HPV-16 E6 mTCR PBL MTD + HD IL-2 | 0 | 2 | 0 |
| other | Fatigue | General disorders | HPV-16 E6 mTCR PBL MTD + HD IL-2-Retreatment | 0 | 1 | 0 |
| other | Hemoglobin | Metabolism and nutrition disorders | HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 1 | 1 | 1 |
| other | Hemoglobin | Metabolism and nutrition disorders | HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 2 | 2 | 2 |
| other | Hemoglobin | Metabolism and nutrition disorders | HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 1 | 1 | 1 |
| other | Hemoglobin | Metabolism and nutrition disorders | HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 4 | 6 | 4 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 0 | 1 |
| Total, all-cause mortality | HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 0 | 2 |
| Total, all-cause mortality | HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 0 | 1 |
| Total, all-cause mortality | HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 0 | 6 |
| Total, all-cause mortality | HPV-16 E6 mTCR PBL MTD + HD IL-2 | 0 | 2 |
| Total, all-cause mortality | HPV-16 E6 mTCR PBL MTD + HD IL-2-Retreatment | 0 | 1 |
| Total, other adverse events | HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 1 | 1 |
| Total, other adverse events | HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 2 | 2 |
| Total, other adverse events | HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 1 | 1 |
| Total, other adverse events | HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 6 | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02280811
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