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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 and 2 years

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

Biospecimen Collection

2004

Completed Phase 3

~2020

Cisplatin

2013

Completed Phase 3

~3120