# De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer

> **NCT03952585** · PHASE2,PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **National Cancer Institute (NCI)** · enrollment: 384 (actual)

## Conditions studied

- 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

- **PROCEDURE:** Biopsy Procedure
- **PROCEDURE:** Biospecimen Collection
- **DRUG:** Cisplatin
- **PROCEDURE:** Computed Tomography
- **OTHER:** Fludeoxyglucose F-18
- **RADIATION:** Image Guided Radiation Therapy
- **RADIATION:** Intensity-Modulated Radiation Therapy
- **PROCEDURE:** Magnetic Resonance Imaging
- **BIOLOGICAL:** Nivolumab
- **PROCEDURE:** Positron Emission Tomography
- **OTHER:** Quality-of-Life Assessment
- **OTHER:** Questionnaire Administration

## Key facts

- **NCT ID:** NCT03952585
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2019-10-09
- **Primary completion:** 2024-03-01
- **Final completion:** 2026-12-11
- **Target enrollment:** 384 (ACTUAL)
- **Last updated:** 2026-05-04

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03952585

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03952585, "De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT03952585. Licensed CC0.

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