← Back to Search

Chemotherapy

De-intensified Radiation Therapy + Cisplatin/Nivolumab for Oropharyngeal Cancer

Phase 2 & 3
Waitlist Available
Led By Sue S Yom
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 and 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a lower dose of radiation therapy with nivolumab for patients with HPV-positive oropharyngeal cancer that is early in growth.

Who is the study for?
This trial is for adults with early-stage, HPV-positive oropharyngeal cancer not linked to smoking. Participants must have a specific type of squamous cell carcinoma, limited smoking history (no more than 10 pack-years), and meet certain health criteria including blood counts and organ function. Those with prior invasive malignancies within 3 years, previous immune therapy, severe allergies to monoclonal antibodies or cisplatin, active autoimmune diseases requiring treatment, or pregnant/nursing women are excluded.
What is being tested?
The study compares the effectiveness of reduced radiation therapy combined with nivolumab (an immunotherapy drug) versus standard radiation therapy paired with cisplatin (a chemotherapy drug). The goal is to see if lower doses of radiation can be as effective when used alongside newer treatments like nivolumab in non-smoking related throat cancer caused by HPV.
What are the potential side effects?
Potential side effects include typical reactions from radiation such as skin irritation and fatigue; chemotherapy-related issues like nausea and kidney effects; and immunotherapy-associated risks such as immune system overactivity leading to inflammation in various organs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 and 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PFS (Phase III)
Progression-free survival (PFS) (Phase II)
Secondary study objectives
Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) locoregional control
Hearing
Incidence of adverse events
+4 more
Other study objectives
Locoregional control for patients with post-RT FDG-PET/CT
PFS for patients with post-RT FDG-PET/CT
Quality of life
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (IMRT, IGRT, nivolumab)Experimental Treatment10 Interventions
Beginning 1 week prior to radiation, patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Group II: Arm II (IMRT, IGRT, cisplatin)Experimental Treatment11 Interventions
Patients undergo reduced dose IMRT or IGRT QD over 5 fractions per week and receive cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Group III: Arm I (IMRT, IGRT, cisplatin)Active Control11 Interventions
Patients undergo IMRT or IGRT over 6 fractions per week and receive cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3120
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Biospecimen Collection
2004
Completed Phase 3
~2030
Computed Tomography
2017
Completed Phase 2
~2790
Positron Emission Tomography
2011
Completed Phase 2
~2200
Biopsy
2014
Completed Phase 4
~1150
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2140
Nivolumab
2015
Completed Phase 3
~4010
Image Guided Radiation Therapy
2016
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,957 Previous Clinical Trials
41,111,703 Total Patients Enrolled
NRG OncologyOTHER
239 Previous Clinical Trials
102,781 Total Patients Enrolled
Sue S YomPrincipal InvestigatorNRG Oncology

Media Library

Cisplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03952585 — Phase 2 & 3
Squamous Cell Carcinoma Research Study Groups: Arm III (IMRT, IGRT, nivolumab), Arm I (IMRT, IGRT, cisplatin), Arm II (IMRT, IGRT, cisplatin)
Squamous Cell Carcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03952585 — Phase 2 & 3
Cisplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03952585 — Phase 2 & 3
~62 spots leftby Dec 2025