Trial · NCT03952585
De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer
NCT03952585, Phase 2, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer. Trials, record NCT03952585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03952585
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer
- NCT number
- NCT03952585
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 384 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Basaloid Squamous Cell Carcinoma, Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Oropharyngeal Squamous Cell Carcinoma, Papillary Squamous Cell Carcinoma, Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Squamous Cell Carcinoma
- Interventions
Biopsy Procedure, Biospecimen Collection, Cisplatin, Computed Tomography, Fludeoxyglucose F-18, Image Guided Radiation Therapy, Intensity-Modulated Radiation Therapy, Magnetic Resonance Imaging, Nivolumab, Positron Emission Tomography, Quality-of-Life Assessment, Questionnaire Administration
- First posted
- 2019-05-16
- Last updated
- 2026-07-02
- Results first posted
- 2025-05-02
- Limitations and caveats
- This phase II/III trial did not proceed to the phase III component, per the protocol. Arm 2 closed to accrual earlier than the other arms due to the timing of the futility analyses.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) (Phase II) (Percentage of Participants Alive Without Progression) | From randomization to first progression or last follow-up. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported. | Progression is defined as local-regional progression or recurrence, distant metastasis, death due to any reason, salvage surgery of primary with tumor present/unknown, salvage neck dissection with tumor present/unknown, \> 20 weeks from end of radiation therapy. Progression-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. The primary phase IIR endpoint is tested using a confidence interval (CI) approach with each experimental arm compared to the standard arm (Arm 1). |
| Primary | Progression-free Survival (Phase III) (Percentage of Participants Alive Without Progression) | From randomization to first progression or last follow-up. Maximum follow-up was 4.6 years. | Progression is defined as local-regional progression or recurrence, distant metastasis, death due to any reason, salvage surgery of primary with tumor present/unknown, salvage neck dissection with tumor present/unknown, \> 20 weeks from end of radiation therapy. Progression-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. |
| Primary | MD Anderson Dysphagia Inventory (MDADI) Global Quality of Life (QOL) Score | Baseline to two years | The M. D. Anderson Dysphagia Inventory (MDADI) assesses how patients view their swallowing ability as a result of treatment and how this affects their QOL. It consists of a global quality of life question and a functional, emotional, and physical subscale. The global QOL question ranges from 1 to 5 and multiplied by 20 to obtain a score with a range of 0 to 100. Higher scores indicate better functioning. |
| Secondary | Locoregional Failure (Percentage of Participants With Locoregional Failure) | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported. | Locoregional failure is defined as local-regional progression or recurrence, death due to study cancer or unknown causes, salvage neck dissection with tumor present/unknown. Locoregional failure rates are estimated the cumulative incidence method, treating distant metastasis and death due to any reason other than study cancer or unknown as competing risks, and otherwise censoring participants alive at time of analysis. Each experimental arm is compared to the standard arm (Arm I). |
| Secondary | Distant Failure (Percentage of Participants With Distant Failure) | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported. | Distant failure is defined as the occurrence of distant metastasis. Distant failure rates are estimated the cumulative incidence method, treating local-regional progression or recurrence, death due to any reason, salvage neck dissection with tumor present/unknown as competing risks, and otherwise censoring participants alive at time of analysis. Each experimental arm is compared to the standard arm (Arm I). |
| Secondary | Overall Survival (Percentage of Participants Alive) | From randomization to death from any cause or last follow-up. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported. | Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. |
| Secondary | Number of Participants by Highest Grade Adverse Event Reported | From randomization to last known follow-up. Maximum follow-up at the time of analysis was 4.6 years. | Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. |
| Secondary | Hearing | Baseline up to 24 months from end of radiation therapy (RT) | Measured as Hearing Handicap Inventory for Adults-Screening (HHIA-S). |
| Secondary | Quality of Life | Baseline up to 24 months from end of RT | Measured by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)30. |
| Secondary | Fludeoxyglucose F-18 (FDG)-Positron Emission Tomography (PET)/Computed Tomography (CT) Locoregional Control | Up to 6 years | Will be associated with PFS. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) (Phase II) (Percentage of Participants Alive Without Progression) | From randomization to first progression or last follow-up. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported. | Randomized phase II participants | percentage of participants | NUMBER |
| PRIMARY | Progression-free Survival (Phase III) (Percentage of Participants Alive Without Progression) | From randomization to first progression or last follow-up. Maximum follow-up was 4.6 years. | Randomized phase III participants. (Phase III component did not and will not open.) | ||
| PRIMARY | MD Anderson Dysphagia Inventory (MDADI) Global Quality of Life (QOL) Score | Baseline to two years | Randomized phase III participants. (Phase III component did not and will not open.) | ||
| SECONDARY | Locoregional Failure (Percentage of Participants With Locoregional Failure) | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported. | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Distant Failure (Percentage of Participants With Distant Failure) | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported. | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (Percentage of Participants Alive) | From randomization to death from any cause or last follow-up. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported. | Randomized participants | Percent of participants | NUMBER |
| SECONDARY | Number of Participants by Highest Grade Adverse Event Reported | From randomization to last known follow-up. Maximum follow-up at the time of analysis was 4.6 years. | Randomized and started protocol treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hearing | Baseline up to 24 months from end of radiation therapy (RT) | |||
| SECONDARY | Quality of Life | Baseline up to 24 months from end of RT | |||
| SECONDARY | Fludeoxyglucose F-18 (FDG)-Positron Emission Tomography (PET)/Computed Tomography (CT) Locoregional Control | Up to 6 years |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) (Phase II) (Percentage of Participants Alive Without Progression) | Arm I (Standard RT + Cisplatin) | 1 year | 99.1 | 95% Confidence Interval 97.3 to 100 | percentage of participants |
| Progression-free Survival (PFS) (Phase II) (Percentage of Participants Alive Without Progression) | Arm II (Reduced RT+ Cisplatin) | 1 year | 96.4 | 95% Confidence Interval 93.0 to 99.9 | percentage of participants |
| Progression-free Survival (PFS) (Phase II) (Percentage of Participants Alive Without Progression) | Arm III (Reduced RT + Nivolumab) | 1 year | 96.6 | 95% Confidence Interval 93.4 to 99.9 | percentage of participants |
| Progression-free Survival (PFS) (Phase II) (Percentage of Participants Alive Without Progression) | Arm I (Standard RT + Cisplatin) | 2 years | 98.1 | 95% Confidence Interval 95.4 to 100 | percentage of participants |
| Progression-free Survival (PFS) (Phase II) (Percentage of Participants Alive Without Progression) | Arm II (Reduced RT+ Cisplatin) | 2 years | 88.6 | 95% Confidence Interval 82.4 to 94.7 | percentage of participants |
| Progression-free Survival (PFS) (Phase II) (Percentage of Participants Alive Without Progression) | Arm III (Reduced RT + Nivolumab) | 2 years | 90.3 | 95% Confidence Interval 84.5 to 96.1 | percentage of participants |
| Locoregional Failure (Percentage of Participants With Locoregional Failure) | Arm I (Standard RT + Cisplatin) | 1 year | 0.0 | 95% Confidence Interval NA to NA | percentage of participants |
| Locoregional Failure (Percentage of Participants With Locoregional Failure) | Arm II (Reduced RT+ Cisplatin) | 1 year | 2.7 | 95% Confidence Interval 0.7 to 7.0 | percentage of participants |
| Locoregional Failure (Percentage of Participants With Locoregional Failure) | Arm III (Reduced RT + Nivolumab) | 1 year | 1.7 | 95% Confidence Interval 0.3 to 5.4 | percentage of participants |
| Locoregional Failure (Percentage of Participants With Locoregional Failure) | Arm I (Standard RT + Cisplatin) | 2 years | 0.0 | 95% Confidence Interval NA to NA | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Standard RT + Cisplatin) | 136 | |
| Overall Study | STARTED | Arm II (Reduced RT+ Cisplatin) | 116 | |
| Overall Study | STARTED | Arm III (Reduced RT + Nivolumab) | 132 | |
| Overall Study | Adverse Event Populaton | Arm I (Standard RT + Cisplatin) | 123 | |
| Overall Study | Adverse Event Populaton | Arm II (Reduced RT+ Cisplatin) | 112 | |
| Overall Study | Adverse Event Populaton | Arm III (Reduced RT + Nivolumab) | 123 | |
| Overall Study | COMPLETED | Arm I (Standard RT + Cisplatin) | 136 | |
| Overall Study | COMPLETED | Arm II (Reduced RT+ Cisplatin) | 116 | |
| Overall Study | COMPLETED | Arm III (Reduced RT + Nivolumab) | 132 | |
| Overall Study | NOT COMPLETED | Arm I (Standard RT + Cisplatin) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events558
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 | Arm I (Standard RT + Cisplatin) | 52 | 123 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Reduced RT+ Cisplatin) | 53 | 112 | |
| other | Anemia | Blood and lymphatic system disorders | Arm III (Reduced RT + Nivolumab) | 33 | 123 | |
| other | Ear pain | Ear and labyrinth disorders | Arm I (Standard RT + Cisplatin) | 7 | 123 | |
| other | Ear pain | Ear and labyrinth disorders | Arm II (Reduced RT+ Cisplatin) | 10 | 112 | |
| other | Ear pain | Ear and labyrinth disorders | Arm III (Reduced RT + Nivolumab) | 10 | 123 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm I (Standard RT + Cisplatin) | 33 | 123 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm II (Reduced RT+ Cisplatin) | 34 | 112 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm III (Reduced RT + Nivolumab) | 10 | 123 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm I (Standard RT + Cisplatin) | 75 | 123 |
1 to 10 of 558Source ClinicalTrials.gov
See all 558 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Standard RT + Cisplatin) | 1 | 136 |
| Total, all-cause mortality | Arm II (Reduced RT+ Cisplatin) | 6 | 116 |
| Total, all-cause mortality | Arm III (Reduced RT + Nivolumab) | 5 | 132 |
| Total, other adverse events | Arm I (Standard RT + Cisplatin) | 123 | 123 |
| Total, other adverse events | Arm II (Reduced RT+ Cisplatin) | 111 | 112 |
| Total, other adverse events | Arm III (Reduced RT + Nivolumab) | 122 | 123 |
| Total, serious adverse events | Arm I (Standard RT + Cisplatin) | 49 | 123 |
| Total, serious adverse events | Arm II (Reduced RT+ Cisplatin) | 32 | 112 |
| Total, serious adverse events | Arm III (Reduced RT + Nivolumab) | 34 | 123 |
Source ClinicalTrials.gov
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 |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | 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/NCT03952585
GET https://conductscience.org/api/trials/v1/NCT03952585/results?page=2