Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03952585 · ClinicalTrials.gov registry record · Phase 2
De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer
A Phase 2 study of Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 384
- Enrollment target
- 20
- Study locations
NCT03952585 is a Phase 2 study of Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 384 participants, above the 96-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (300% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT03952585, a Phase 2 study of Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 384 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- PROCEDURE Biopsy Procedure
- OTHER Fludeoxyglucose F-18
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
- Tower Cancer Research Foundation - Beverly Hills
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente Dublin - Dublin
- UC San Diego Health System - Encinitas - Encinitas
- Kaiser Permanente-Fremont - Fremont
- Fresno Cancer Center - Fresno
- Kaiser Permanente-Fresno - Fresno
- City of Hope at Irvine Lennar - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- City of Hope Antelope Valley - Lancaster
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2026-12-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03952585
The ClinicalTrials.gov registry entry for NCT03952585 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 96-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (300% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03952585 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT03952585 about?
NCT03952585 is a clinical study titled "De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer". This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and...
What is the current status of trial NCT03952585?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 384 participants. The study started on 2019-10-09. Estimated completion is 2026-12-11.
What conditions does trial NCT03952585 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8.
What interventions are being tested in trial NCT03952585?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Biopsy Procedure (PROCEDURE), Fludeoxyglucose F-18 (OTHER).
Who is sponsoring clinical trial NCT03952585?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03952585 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Squamous Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma
RECRUITING · Phase 2
-
Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin
RECRUITING · Phase 2
-
Toripalimab With Chemotherapy for Sinus Cancer
RECRUITING · Phase 2
-
Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design
RECRUITING · Phase 2
-
Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
RECRUITING · Phase 2
-
Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)
RECRUITING · Phase 2
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.