Trial · NCT02865135
Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer
NCT02865135, Phase 1, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2024-01-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer. Trials, record NCT02865135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02865135
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer
- NCT number
- NCT02865135
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Cancer of Head and Neck, Cancer of Cervix, Cancer of Anus
- Interventions
- DPX-E7 vaccine, Cyclophosphamide
- First posted
- 2016-08-12
- Last updated
- 2024-01-11
- Results first posted
- 2024-01-11
- Limitations and caveats
- Week accrual leading to small numbers of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicity (DLT) [Phase 1b] | Patients were followed for 50 days. | A DLT was defined as any grade 3 or greater adverse event at least possibly related to the study agent including injection site reactions; or grade 2 or greater allergic reactions which occur in a subject prior to day 50, will trigger DLT. In addition, to be considered as DLT, the adverse event must be considered at least possibly related to study treatment. Grade 3 or greater abnormal lab values lasting \<= 72 hours might be excluded as DLTs if there are no accompanying clinical signs and symptoms per investigator's discretion. |
| Primary | Grade 1-2 Treatment-Related AE Rate | The median follow up was 2.92 months (range 1.25 - 5.88months). | The proportion of participants who experienced grade 1-2 treatment-related adverse events based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4) as reported on case report forms. |
| Primary | Changes in CD8+ T Cells in Peripheral Blood and Tumor Tissue | Patients were followed 22 days. | 'Responders' will be defined as patients with at least a two-fold increase in the number of CD 8+ T cells (dextramer, ELISpot or both methods) in the peripheral blood and tissue at the final analysis. |
| Secondary | Best Overall Response | The median follow up was 2.92 months (range 1.25 - 5.88months). | Best Overall Response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started) based on modified RECIST 1.1 and irRECIST. Per irRECIST, CR was defined as disappearance of all lesions in two consecutive observations not less than four weeks apart; PR was defined as greater than or equal to 50% decrease in tumor burden compared with baseline in two observations at least four weeks apart. |
| Secondary | Median Overall Survival | The median follow up was 4.8 months (range 1.6 - 14.9 months). | Overall survival based on the Kaplan-Meier method is defined as the time the start of treatment to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant. |
| Secondary | Median Progression-Free Survival | The median follow up was 4.8 months (range 1.6 - 14.9 months). | PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study or the appearance of one or more new lesions. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated. |
| Secondary | Time to Progression (TTP) | The median follow up was 4.8 months (range 1.6 - 14.9 months). | TTP is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Participants alive without PD were censored at the earliest of the date of the last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study or the appearance of one or more new lesions. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated. |
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 | Number of Participants With Dose Limiting Toxicity (DLT) [Phase 1b] | Patients were followed for 50 days. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Grade 1-2 Treatment-Related AE Rate | The median follow up was 2.92 months (range 1.25 - 5.88months). | proportion of participants | NUMBER | |
| PRIMARY | Changes in CD8+ T Cells in Peripheral Blood and Tumor Tissue | Patients were followed 22 days. | Data were not collected for participants who registered after amendment 10. | percentage of participants | NUMBER |
| SECONDARY | Best Overall Response | The median follow up was 2.92 months (range 1.25 - 5.88months). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Overall Survival | The median follow up was 4.8 months (range 1.6 - 14.9 months). | The analysis dataset is comprised of all enrolled participants. | Months | MEDIAN |
| SECONDARY | Median Progression-Free Survival | The median follow up was 4.8 months (range 1.6 - 14.9 months). | The analysis dataset is comprised of all enrolled participants | Months | MEDIAN |
| SECONDARY | Time to Progression (TTP) | The median follow up was 4.8 months (range 1.6 - 14.9 months). | The analysis dataset is comprised of all enrolled patients. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicity (DLT) [Phase 1b] | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | 0 | Participants | ||
| Grade 1-2 Treatment-Related AE Rate | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | 0.66 | 95% Confidence Interval 0.22 to 0.96 | proportion of participants | |
| Grade 1-2 Treatment-Related AE Rate | DPX-E7 + Cyclophosphamide [Phase II Cohort 1] | 1 | 95% Confidence Interval 0.01 to 1 | proportion of participants | |
| Grade 1-2 Treatment-Related AE Rate | DPX-E7 [Phase II Cohort 2] | 1 | 95% Confidence Interval 0 to 1 | proportion of participants | |
| Changes in CD8+ T Cells in Peripheral Blood and Tumor Tissue | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | Responders | 16.7 | 95% Confidence Interval 0.6 to 64.1 | percentage of participants |
| Changes in CD8+ T Cells in Peripheral Blood and Tumor Tissue | DPX-E7 + Cyclophosphamide [Phase II Cohort 1] | Responders | 0 | 95% Confidence Interval 0 to 70.8 | percentage of participants |
| Changes in CD8+ T Cells in Peripheral Blood and Tumor Tissue | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | Non-responder | 83.3 | 95% Confidence Interval 35.9 to 99.6 | percentage of participants |
| Changes in CD8+ T Cells in Peripheral Blood and Tumor Tissue | DPX-E7 + Cyclophosphamide [Phase II Cohort 1] | Non-responder | 100 | 95% Confidence Interval 29.2 to 100 | percentage of participants |
| Best Overall Response | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | SD | 2 | Participants | |
| Best Overall Response | DPX-E7 + Cyclophosphamide [Phase II Cohort 1] | SD | 1 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | 6 | |
| Overall Study | STARTED | DPX-E7 + Cyclophosphamide [Phase II Cohort 1] | 3 | |
| Overall Study | STARTED | DPX-E7 [Phase II Cohort 2] | 2 | |
| Overall Study | Evaluable for T Cell Analysis | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | 6 | |
| Overall Study | Evaluable for T Cell Analysis | DPX-E7 + Cyclophosphamide [Phase II Cohort 1] | 3 | |
| Overall Study | Evaluable for T Cell Analysis | DPX-E7 [Phase II Cohort 2] | 0 | |
| Overall Study | COMPLETED | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | 0 | |
| Overall Study | COMPLETED | DPX-E7 + Cyclophosphamide [Phase II Cohort 1] | 0 | |
| Overall Study | COMPLETED | DPX-E7 [Phase II Cohort 2] | 0 | |
| Overall Study | NOT COMPLETED | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events231
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 | Anemia | Blood and lymphatic system disorders | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | 3 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | DPX-E7 + Cyclophosphamide [Phase II Cohort 1] | 1 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | DPX-E7 [Phase II Cohort 2] | 1 | 2 | |
| other | Palpitations | Cardiac disorders | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | 1 | 6 | |
| other | Palpitations | Cardiac disorders | DPX-E7 + Cyclophosphamide [Phase II Cohort 1] | 0 | 3 | |
| other | Palpitations | Cardiac disorders | DPX-E7 [Phase II Cohort 2] | 0 | 2 | |
| other | Sinus bradycardia | Cardiac disorders | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | 1 | 6 | |
| other | Sinus bradycardia | Cardiac disorders | DPX-E7 + Cyclophosphamide [Phase II Cohort 1] | 0 | 3 | |
| other | Sinus bradycardia | Cardiac disorders | DPX-E7 [Phase II Cohort 2] | 0 | 2 | |
| other | Ear pain | Ear and labyrinth disorders | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | 0 | 6 |
1 to 10 of 231Source ClinicalTrials.gov
See all 231 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | 3 | 6 |
| Total, all-cause mortality | DPX-E7 + Cyclophosphamide [Phase II Cohort 1] | 2 | 3 |
| Total, all-cause mortality | DPX-E7 [Phase II Cohort 2] | 0 | 2 |
| Total, other adverse events | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | 6 | 6 |
| Total, other adverse events | DPX-E7 + Cyclophosphamide [Phase II Cohort 1] | 3 | 3 |
| Total, other adverse events | DPX-E7 [Phase II Cohort 2] | 2 | 2 |
| Total, serious adverse events | DPX-E7 + Cyclophosphamide [Phase Ib Cohort] | 2 | 6 |
| Total, serious adverse events | DPX-E7 + Cyclophosphamide [Phase II Cohort 1] | 0 | 3 |
| Total, serious adverse events | DPX-E7 [Phase II Cohort 2] | 1 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02865135
GET https://conductscience.org/api/trials/v1/NCT02865135/results?page=2