Trial · NCT02426892
Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid Tumors
NCT02426892, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2023-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid Tumors. Trials, record NCT02426892. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02426892
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid Tumors
- NCT number
- NCT02426892
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Solid Tumors
- Interventions
- ISA 101, Nivolumab
- First posted
- 2015-04-27
- Last updated
- 2023-04-18
- Results first posted
- 2023-04-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Overall Response Rate (ORR) | From the time of the first protocol-specific intervention, every 6 weeks until progression, death, withdrawal of consent or study completion, an average of 4.5 years | ORR defined as sum of subjects with a complete response (CR) and partial response (PR) divided by number of evaluable subjects at 11 weeks from start of treatment. RECIST 1.1 criteria used for assessment. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Median Progression Free Survival (PFS) | From the time of the first protocol-specific intervention, every 6 weeks until progression, death, withdrawal of consent or study completion, an average of 4.5 years. | PFS is defined as the time from first day of treatment to the date of the first documented tumor progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.1). RECIST V1.1 defines progression as at least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm. Additionally, the appearance of one or more new lesions is also considered progression. Progression Free survival will be summarized using the method of Kaplan and Meier and Cox proportional hazards model. |
| Secondary | Progression Free Survival (PFS) Rates at 2 and 3 Years | From the time of the first protocol-specific intervention, every 6 weeks until progression, death, withdrawal of consent or study completion, an average of 3 years. | PFS is defined as the time from first day of treatment to the date of the first documented tumor progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.1). RECIST V1.1 defines progression as at least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm. Additionally, the appearance of one or more new lesions is also considered progression. Progression Free survival will be summarized using the method of Kaplan and Meier and Cox proportional hazards model. |
| Secondary | Median Overall Survival | 3 years | OS is defined as the time from treatment to the date of death, whichever comes first. Overall survival will be summarized using the method of Kaplan and Meier) and Cox proportional hazards model. |
| Secondary | Overall Survival (OS) Rates at 2 and 3 Years | up to 3 years | OS is defined as the time from treatment to the date of death. Overall survival will be summarized using the method of Kaplan and Meier) and Cox proportional hazards model. |
| Secondary | Number of Participants With Adverse Events | at baseline, and continuously throughout the study at the beginning of each subsequent cycle, up to 3 years | The safety and tolerability which will be measured by the incidence of adverse events, serious adverse events, deaths, and laboratory abnormalities. Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. Laboratory abnormalities are Any laboratory test result that is clinically significant or meets the definition of an SAE, laboratory abnormality that required the subject to have study drug discontinued or interrupted, laboratory abnormality that required the subject to receive specific corrective therapy. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. |
Source ClinicalTrials.gov
Outcomes6
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 Overall Response Rate (ORR) | From the time of the first protocol-specific intervention, every 6 weeks until progression, death, withdrawal of consent or study completion, an average of 4.5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Progression Free Survival (PFS) | From the time of the first protocol-specific intervention, every 6 weeks until progression, death, withdrawal of consent or study completion, an average of 4.5 years. | months | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) Rates at 2 and 3 Years | From the time of the first protocol-specific intervention, every 6 weeks until progression, death, withdrawal of consent or study completion, an average of 3 years. | months | MEDIAN | |
| SECONDARY | Median Overall Survival | 3 years | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) Rates at 2 and 3 Years | up to 3 years | months | MEDIAN | |
| SECONDARY | Number of Participants With Adverse Events | at baseline, and continuously throughout the study at the beginning of each subsequent cycle, up to 3 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
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 Overall Response Rate (ORR) | ISA101 Vaccine and Nivolumab | Complete Response (CR) | 2 | Participants | |
| Number of Participants With Overall Response Rate (ORR) | ISA101 Vaccine and Nivolumab | Partial Response (PR) | 6 | Participants | |
| Median Progression Free Survival (PFS) | ISA101 Vaccine and Nivolumab | 2.66 | 95% Confidence Interval 2.5 to 9.44 | months | |
| Progression Free Survival (PFS) Rates at 2 and 3 Years | ISA101 Vaccine and Nivolumab | 2 Years | 12.5 | 95% Confidence Interval 4.3 to 36 | months |
| Progression Free Survival (PFS) Rates at 2 and 3 Years | ISA101 Vaccine and Nivolumab | 3 Years | 12.5 | 95% Confidence Interval 4.3 to 36 | months |
| Median Overall Survival | ISA101 Vaccine and Nivolumab | 15.3 | 95% Confidence Interval 10.6 to 27.2 | months | |
| Overall Survival (OS) Rates at 2 and 3 Years | ISA101 Vaccine and Nivolumab | 2 Years | 33 | 95% Confidence Interval 18.9 to 58.7 | months |
| Overall Survival (OS) Rates at 2 and 3 Years | ISA101 Vaccine and Nivolumab | 3 Years | 12.5 | 95% Confidence Interval 4.3 to 36 | months |
| Number of Participants With Adverse Events | ISA101 Vaccine and Nivolumab | Adverse Events | 23 | Participants | |
| Number of Participants With Adverse Events | ISA101 Vaccine and Nivolumab | Serious Adverse Events | 11 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ISA101 Vaccine and Nivolumab | 24 | |
| Overall Study | COMPLETED | ISA101 Vaccine and Nivolumab | 4 | |
| Overall Study | NOT COMPLETED | ISA101 Vaccine and Nivolumab | 20 |
Source ClinicalTrials.gov
Adverse events152
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 | Abdominal pain | Gastrointestinal disorders | ISA101 Vaccine and Nivolumab | 3 | 24 | 3 |
| other | Activated partial thromboplastin time prolonged | Investigations | ISA101 Vaccine and Nivolumab | 1 | 24 | 1 |
| other | Acute kidney injury | Renal and urinary disorders | ISA101 Vaccine and Nivolumab | 1 | 24 | 1 |
| other | Alanine aminotransferase increased | Investigations | ISA101 Vaccine and Nivolumab | 3 | 24 | 6 |
| other | Alkaline phosphatase increased | Investigations | ISA101 Vaccine and Nivolumab | 6 | 24 | 8 |
| other | Allergic reaction | Immune system disorders | ISA101 Vaccine and Nivolumab | 1 | 24 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | ISA101 Vaccine and Nivolumab | 1 | 24 | 1 |
| other | Anemia | Blood and lymphatic system disorders | ISA101 Vaccine and Nivolumab | 17 | 24 | 44 |
| other | Anorexia | Metabolism and nutrition disorders | ISA101 Vaccine and Nivolumab | 6 | 24 | 6 |
| other | Anxiety | Psychiatric disorders | ISA101 Vaccine and Nivolumab | 4 | 24 | 4 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ISA101 Vaccine and Nivolumab | 20 | 24 |
| Total, other adverse events | ISA101 Vaccine and Nivolumab | 23 | 24 |
| Total, serious adverse events | ISA101 Vaccine and Nivolumab | 11 | 24 |
Source ClinicalTrials.gov
Papers2
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/NCT02426892
GET https://conductscience.org/api/trials/v1/NCT02426892/events?page=2