Trial · NCT03811015
Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer
NCT03811015, Phase 3, Active not recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer. Trials, record NCT03811015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03811015
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer
- NCT number
- NCT03811015
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 636 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Interventions
- Biospecimen Collection, Cisplatin, Computed Tomography, Echocardiography Test, Fludeoxyglucose F-18, Intensity-Modulated Radiation Therapy, Nivolumab, Patient Observation, Positron Emission Tomography
- First posted
- 2019-01-22
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival (OS) | From randomization to death, assessed up to 10 years | Log rank test will be used to compare OS. As patients on the observation arm are allowed to cross-over to the nivolumab arm upon progression, an overall survival analysis using inverse probability censoring weights (IPCW, Robins et. al, 2000) will also be considered. Kaplan-Meier method and Cox regression will be used for the survival outcome analyses. |
| Primary | Negative (standardized qualitative) 12 week post therapy (cisplatin + radiation therapy [RT]) FDG positron emission tomography/computed tomography (PET/CT) associated with OS for patients who have a PET/CT | At 12 weeks post therapy | Logrank tests and input hazard rates will be used. |
| Primary | Negative (standardized qualitative) 12 week post therapy (cisplatin + RT) FDG PET/CT associated with PFS for patients who have a PET/CT | At 12 weeks post therapy | Logrank tests and input hazard rates will be used. |
| Secondary | Progression-free survival (PFS) | From randomization to date of progression, second primary tumor from the head and neck region, or death, assessed up to 10 years | Progression will be defined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. The comparison of PFS will use stratified log rank test and will be intent-to-treat analyses. |
| Secondary | Prognostic effect of baseline PD-L1 expression (positive versus [vs.] negative) on OS and PFS | Baseline up to 10 years | Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses. |
| Secondary | Prognostic effect of baseline saliva and/or plasma human papillomavirus (HPV) status (positive vs. negative) on OS and PFS | Baseline up to 10 years | Saliva and plasma HPV status at 12 weeks and 9 months following completion of concurrent therapy will also be analyzed regarding effect on outcome. Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses. |
| Secondary | Prognostic value of maximum standardized uptake value (SUVmax) of primary tumor or neck nodal metastasis of baseline FDG PET/CT for OS | Baseline up to 10 years | Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses. |
| Secondary | Prognostic value of SUVmax of primary tumor or neck nodal metastasis of baseline FDG PET/CT for PFS | Baseline up to 10 years | Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses. |
| Secondary | SUVmax of primary tumor or nodal metastasis of baseline FDG PET/CT with PD-L1 expression (positive vs. negative) | Baseline up to 10 years | Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses. |
| Secondary | Post therapy (cisplatin + RT) FDG PET/CT with saliva or plasma levels of HPV deoxyribonucleic acid (DNA) | Up to 9 months post-therapy | Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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/NCT03811015
GET https://conductscience.org/api/trials/v1/NCT03811015/registered