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Recurrent Head and Neck Squamous Cell CarcinomaPhase 2NCT03521570

Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer

A Phase 2 study testing IMRT and Nivolumab in people with Recurrent Head and Neck Squamous Cell Carcinoma, run by Emory University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies how well intensity-modulated radiotherapy and nivolumab work together in treating patients with head and neck squamous cell cancer that has come back. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IMRT and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
4 sitesUnited States
Study dates
28 Jun 2018to 7 Sep 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with recurrent squamous cell carcinoma or a second primary arising in a previously irradiated field
  • Life expectancy of greater than 6 months
  • Patients cannot have distant metastases and have to be candidates for curative re-irradiation
  • Patients with salivary gland tumors are excluded (patients with nasopharynx or sinonasal cancers can participate)
  • Patients with unresectable disease are eligible
  • Patients who undergo surgical resection will be allowed regardless of human papilloma virus (HPV) status provided they have one of the following criteria:
Show all 22Show fewer
  • Positive margins on pathology
  • Evidence of extracapsular spread on nodal pathology
  • Gross residual disease on postoperative or simulation imaging
  • N2/3 disease
  • T3/4 disease
  • Multifocal perineural invasion and/or lymphovascular space invasion
  • The majority of the anticipated target volume (> 50%) must have been previously treated to ≥ 40 Gy; prior radiation therapy (RT) must have been completed > 6 months prior to initiation of IMRT reirradiation; if previous RT records are unavailable, investigators can estimate the dose to previously treated tissues based on completion notes or other treatment history
  • An Eastern Cooperative Oncology Group (ECOG) performance score 0-2
  • Granulocytes > 1500/mm³
  • Platelets > 100,000/mm³
  • Bilirubin < 1.5 mg/dl
  • Creatinine < 1.5 mg/dl
  • No other concurrent invasive malignancies treated for the past year (localized prostate cancer or early stage skin cancer are not exclusion criteria)
  • Patients with carotid artery involvement or encasement will be allowed provided they have no symptoms related to carotid involvement
  • No prior exposure to immunotherapy agents
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Any known factors that would pose a contraindication to receiving nivolumab
  • Recursive partitioning analysis (RPA) class III patients defined as those expected to begin reirradiation within 2 years of first course of radiation therapy AND are percutaneous endoscopic gastrostomy (PEG) dependent or have a tracheostomy (patients who have undergone total laryngectomy are not excluded)
  • Patients with metastases
  • Prior treatment with a programmed cell death protein-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor
  • Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment
  • Patients with primary salivary gland cancers are excluded
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  • Patients who have had chemotherapy or biological therapy within 4 weeks of registration
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disease requiring systemic steroids, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients who are pregnant or breast-feeding
  • Patients with known active human immunodeficiency virus (HIV), hepatitis (hep) B, or hep C infection
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: Phase II Study of IMRT Re-Irradiation With Concurrent/Adjuvant Nivolumab in Patients With Locoregionally Recurrent or Second Primary Squamous Cell Cancer of the Head and Neck

This phase II trial studies how well intensity-modulated radiotherapy and nivolumab work together in treating patients with head and neck squamous cell cancer that has come back. Intensity-modulation radiation therapy uses varying intensities of radiation beams to kill cancer cells and shrink tumors, thereby reducing the damage to nearby healthy tissue. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving intensity-modulated radiation therapy and nivolumab may work better at treating head and neck squamous cell cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the 1-year progression-free survival (PFS) for patients with recurrent or second primary head and neck squamous cancer treated with intensity-modulated radiation therapy (IMRT) re-irradiation with concurrent and adjuvant nivolumab.

SECONDARY OBJECTIVES:

  1. Evaluate the 1-year (yr) overall survival (OS) of patients treated with re-irradiation and nivolumab.

II. Evaluate patient quality of life (QOL).

III. Evaluate patterns of failure including local, regional and distant failure rates at 1 yr.

IV. Identify and estimate the incidence rate of acute and late toxicities associated with combined re-irradiation and concurrent and adjuvant nivolumab.

TERTIARY OBJECTIVE:

  1. To identify potential biomarkers related to clinical benefit to concurrent and adjuvant nivolumab and re-irradiation in patients with recurrent or second primary (RSP) head and neck squamous cell carcinoma (HNSCC).

OUTLINE:

Patients receive nivolumab intravenously (IV) over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years from the beginning of radiation therapy.

Being tested
IMRT, Nivolumab
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMRTRadiation

    Also called Intensity-Modulated Radiation Therapy, Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo intensity-modulated radiation therapy

  • NivolumabBiological

    Also called BMS-936558, MDX-1106, ONO-4538, Opdivo

    Given IV

Study groups in NCT03521570
Study groupRoleWhat they receive
Treatment (nivolumab, IMRT)ExperimentalPatients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: IMRT; Biological: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Progression-Free Survival (PFS)

    95% confidence interval will be estimated by Kaplan-Meier method for all participants.

    Measured: 1 year from study start

Secondary outcomes (5)

  1. Number of Participants With Overall Survival (OS)

    Will be assessed using Kaplan-Meier method.

    Measured: 1 year from study start

  2. Number of Participants With Pattern of Failure

    To evaluate patterns of failure as local, regional, or distant.

    Measured: 1 year from study start

  3. Number of Participants With Incidence of Acute Adverse Events

    Acute toxicities will be identified and their incidence rate estimated.

    Measured: Up to 1 year from study start

  4. Number of Participants With Incidence of Late Adverse Events

    Late toxicities will be identified and their incidence rate estimated.

    Measured: 2 years from study start

  5. Quality of Life (QOL)

    The FACT-HN (Functional Assessment of Cancer Therapy-Head and Neck) (version 4) consists of a cancer-specific questionnaire, FACT-G (Functional Assessment of Cancer Therapy - General), in addition to 12 H\&N cancer-specific items (the HN subscale).The Functional Assessment of Cancer Therapy-Head and Neck Quality of Life questionnaire may be completed by the patient using paper or electronically. FACT-HN total score ranges between 0 and 148. The higher the score, the better the QOL

    Measured: At baseline, end of Intensity-Modulated Radiation Therapy, and weeks 18, 30, 52, and 104, baseline and month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2018
  2. Study start28 Jun 2018
  3. Primary completion25 Jul 2022
  4. Study completion7 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03521570
Sponsor's protocol ID
IRB00100923
Other IDs
NCI-2018-00064, Winship4221-17, P30CA138292
Status last verified
Sep 2024
First submitted
30 Apr 2018
Last updated
19 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Saba NF, Wong SJ, Nasti T, McCook-Veal AA, McDonald MW, Stokes WA, Anderson AM, Ekpenyong A, Rupji M, Abousaud M, Rudra S, Bates JE, Remick JS, Joshi NP, Woody NM, Awan M, Geiger JL, Shreenivas A, Samsa J, Ward MC, Schmitt NC, Patel MR, Higgins KA, Teng Y, Steuer CE, Shin DM, Liu Y, Ahmed R, Koyfman SA. Intensity-Modulated Reirradiation Therapy With Nivolumab in Recurrent or Second Primary Head and Neck Squamous Cell Carcinoma: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Jul 1;10(7):896-904. doi: 10.1001/jamaoncol.2024.1143.

    PubMed 38780927

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMRT and Nivolumab in people with Recurrent Head and Neck Squamous Cell Carcinoma, run by Emory University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Progression-Free Survival (PFS) (time frame: 1 year from study start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03521570, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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