Head and Neck CancerPhase 2NCT04938609
Neoadjuvant Immunoradiotherapy in Head & Neck Cancer (NIRT 2-HNC)
A Phase 2 study testing Pembrolizumab, Stereotactic Body Radiation Therapy (5 days) and Surgical Resection in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Providence Health & Services at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of neoadjuvant immunoradiotherapy (NIRT) prior to surgery for the treatment of stage III and IVA HPV- HNSCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Pembrolizumab, Stereotactic Body Radiation Therapy (5 days) and Surgical Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jan 2022to 11 Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male/female participants who are at least 18 years of age on the day of signing informed consent.
- Histologically confirmed diagnosis of stage III-IVA HPV-negative HNSCC who are planned for surgical resection and in the opinion of the investigator are able to safely undergo neoadjuvant anti-PD-1 and radiation will be enrolled in this study. Oral cavity, hypopharynx, and larynx cancer are not required to undergo HPV testing by p16 IHC as by convention these tumor locations are assumed to be HPV-negative
- Male participants:
- A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 75 days, corresponding to time needed to eliminate any study treatment) plus an additional 120 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period.
- Female participants:
- A female participant is eligible to participate if she is not pregnant (see Appendix 3),or breastfeeding and at least one of the following conditions applies:
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- Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 75 days (corresponding to time needed to eliminate any study treatment) plus 30 days (a menstruation cycle) after the last dose of study treatment.
- The participant must provide (or legally acceptable representative if applicable) written informed consent for the trial.
- Have provided archival tumor tissue sample collected within the last 6 months or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- Note: If submitting unstained slides, slides should be submitted to the testing laboratory within 14 days from the date slides are cut. For archival tissue samples collected >6 months from screening, PI approval is required.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 10 days prior to the date of enrollment
- Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 10 days prior to the start of study treatment.
Who cannot join
- A WOCBP who has a positive serum or urine pregnancy test within 72 hours prior to first dose of pembrolizumab (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks [could consider shorter interval for kinase inhibitors or other short half-life drugs] prior to enrollment
- Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.
- Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- Has received prior radiotherapy to the head and neck region.
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- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) or other solid tumor or hematologic malignancy that have undergone potentially curative therapy outside of the head and neck are not excluded.
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV) testing is not required unless mandated by local health authority
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Has a known history of active TB (Bacillus Tuberculosis). testing is not required unless mandated by local health authority
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Patients with T1,T2 and T3 larynx cancer are excluded.
- Patients with prior history of solid organ and/or allo-transplantation.
- Patients with pre-existing neuropathy of grade 2 or higher peripheral neuropathy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Portland Providence Medical Center
Portland, Oregon, 97213
Providence St. Vincent Medical Center
Portland, Oregon, 97225
University of San Diego
San Diego, California, 92037
About this study
The purpose of this study is to evaluate the efficacy of neoadjuvant immunoradiotherapy (NIRT) prior to surgery for the treatment of stage III and IVA HPV- HNSCC.
Read the detailed description
This clinical trial uses pembrolizumab and radiotherapy prior to definitive surgical resection of tumors in patients with Head and Neck Squamous Cell Carcinoma (OHNSCC) with the primary objective of determining the safety and efficacy of preoperative immunoradiotherapy. In addition, tumor tissue, microbiome samples, and peripheral blood will be obtained for exploratory immunologic end points including measurements of tumor infiltrating immune cell populations based on flow cytometry and immunohistochemistry as well as circulating immunological parameters.
Estimated duration of 52 weeks: neoadjuvant immunoradiotherapy +/- surgery at week 7, followed by risk adapted adjuvant therapy, per standard of care. Patients will then be treated with adjuvant pembrolizumab every 3 weeks for 14 additional doses (17 doses total).
Phase II efficacy study (n = 28, total) to assess rate of down-staging after neoadjuvant immunoradiotherapy using Simon's two-stage design (futility assessment at n = 12).
Phase I studied nivolumab in 10 patients with HPV+ HNSCC, the results of which suggest that the combination is safe and efficacious. The phase II portion of study will evaluate the efficacy of neoadjuvant pembrolizumab in combination with SBRT as a safe means to down-stage HNSCC prior to surgical resection, improve quality of life, and enhance local control and overall survival. Patients will be followed for disease free and overall survival at 5 years.
Eligible patients may be enrolled unless a rate of unplanned surgical delay attributed to immunoradiotherapy is found to exceed 33% after enrollment of the first 10 patients. We estimate at least 2 patients per month will be enrolled. Time to full accrual is estimated as 2.5 years.
- Being tested
- Pembrolizumab, Stereotactic Body Radiation Therapy (5 days), Surgical Resection
- Keywords
- HNSCC, radiation, surgery, pembrolizumab, Phase 2, immunotherapy, antibodies
- Medical subject headings
- Head and Neck Neoplasms, 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.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
Stereotactic Body Radiation Therapy (5 days)Radiation
8Gy x 3 (Mon-Fri) GTV+3mm
Surgical ResectionProcedure or surgery
Surgical Resection of Tumor
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + SBRT + Surgery | Experimental | Pembrolizumab administration (3 dose) every 3 weeks and 1 dose before radiation (5 days) therapy followed by an additional administration of Pembrolizumab (2 doses) prior to restaging and surgical resection followed by risk-adapted adjuvant therapy, per standard of care. Patient will then be treated with adjuvant pembrolizumab every 3 weeks for 14 additional doses (17 doses total) Receives: Drug: Pembrolizumab; Radiation: Stereotactic Body Radiation Therapy (5 days); Procedure: Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the pathologic response rate (MPR + pCR) at time of surgery
Prior to surgery neoadjuvant immunoradiotherapy (NIRT) with stereotactic body radiation therapy (SBRT) + pembrolizumab in stage III-IVA HPV-negative HNSCC patients.
Measured: 52 weeks
Secondary outcomes (10)
Overall Response Rate
Number of patients who have a partial or complete response to treatment per RECIST 1.1.
Measured: 5 years
Clinical swallowing evaluation assessed by VFSS
Clinical swallowing evaluation using the Video Fluoroscopic Swallowing Study (VFSS)
Measured: 5 years
Quality of Life assessed by PSS-HN
Quality of life using the Performance Status Scale for Head and Neck Cancer (PSS-HN)
Measured: 5 years
Quality of Life assessed by FACT-H&N
Quality of life using Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H\&N)
Measured: 5 years
Quality of Life assessed by MDASI-HN
Quality of life using the MD Anderson Symptom Inventory for head and neck cancer (MDASI-HN) module.
Measured: 5 years
Quality of Life assessed by Eat-10
Quality of life using the Eating Assessment Tool (Eat-10)
Measured: 5 year
Quality of Life assessed by FOIS
Quality of life using the Functional Oral Intake Scale FOIS
Measured: 5 years
Quality of Life assessed by UW-QOL
Quality of life using the University of Washington Quality of Life Questionnaire (UW-QOL)
Measured: 5 years
Adverse events
Frequency, duration, and severity of adverse events
Measured: From time of informed consent through 90 days after the last study treatment
Surgical Complications
Post surgery: Clavien-Dindo classification for grading surgical complications
Measured: 30 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start11 Jan 2022
- Primary completion11 Jan 2027 (estimated)
- Study completion11 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Cancer Center, Earle A. Chiles Research Institute
- Responsible party
- Sponsor
- Investigators
- R. Bryan Bell, MD, DDS, FACS, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938609
- Sponsor's protocol ID
- 2020000720 NIRT 2
- Status last verified
- Apr 2026
- First submitted
- 9 Jun 2021
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Immunoradiotherapy in Head & Neck Cancer (NIRT 2-HNC)
- ClinicalTrials.gov ID
- NCT04938609
- Acronym / sponsor ID
- 2020000720 NIRT 2
- Keywords
- HNSCC, radiation, surgery, pembrolizumab, Phase 2, immunotherapy, antibodies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Providence Cancer Center, Earle A. Chiles Research Institute
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 11 Jan 2027 (estimated)
- Study completion
- 11 Jan 2031 (estimated)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of neoadjuvant immunoradiotherapy (NIRT) prior to surgery for the treatment of stage III and IVA HPV- HNSCC.
Detailed description
This clinical trial uses pembrolizumab and radiotherapy prior to definitive surgical resection of tumors in patients with Head and Neck Squamous Cell Carcinoma (OHNSCC) with the primary objective of determining the safety and efficacy of preoperative immunoradiotherapy. In addition, tumor tissue, microbiome samples, and peripheral blood will be obtained for exploratory immunologic end points including measurements of tumor infiltrating immune cell populations based on flow cytometry and immunohistochemistry as well as circulating immunological parameters.
Estimated duration of 52 weeks: neoadjuvant immunoradiotherapy +/- surgery at week 7, followed by risk adapted adjuvant therapy, per standard of care. Patients will then be treated with adjuvant pembrolizumab every 3 weeks for 14 additional doses (17 doses total).
Phase II efficacy study (n = 28, total) to assess rate of down-staging after neoadjuvant immunoradiotherapy using Simon's two-stage design (futility assessment at n = 12).
Phase I studied nivolumab in 10 patients with HPV+ HNSCC, the results of which suggest that the combination is safe and efficacious. The phase II portion of study will evaluate the efficacy of neoadjuvant pembrolizumab in combination with SBRT as a safe means to down-stage HNSCC prior to surgical resection, improve quality of life, and enhance local control and overall survival. Patients will be followed for disease free and overall survival at 5 years.
Eligible patients may be enrolled unless a rate of unplanned surgical delay attributed to immunoradiotherapy is found to exceed 33% after enrollment of the first 10 patients. We estimate at least 2 patients per month will be enrolled. Time to full accrual is estimated as 2.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + SBRT + Surgery | Experimental | Drug: Pembrolizumab, Radiation: Stereotactic Body Radiation Therapy (5 days), Procedure: Surgical ResectionPembrolizumab administration (3 dose) every 3 weeks and 1 dose before radiation (5 days) therapy followed by an additional administration of Pembrolizumab (2 doses) prior to restaging and surgical resection followed by risk-adapted adjuvant therapy, per standard of care. Patient will then be treated with adjuvant pembrolizumab every 3 weeks for 14 additional doses (17 doses total) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male/female participants who are at least 18 years of age on the day of signing informed consent.
- Histologically confirmed diagnosis of stage III-IVA HPV-negative HNSCC who are planned for surgical resection and in the opinion of the investigator are able to safely undergo neoadjuvant anti-PD-1 and radiation will be enrolled in this study. Oral cavity, hypopharynx, and larynx cancer are not required to undergo HPV testing by p16 IHC as by convention these tumor locations are assumed to be HPV-negative
- A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 75 days, corresponding to time needed to eliminate any study treatment) plus an additional 120 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant (see Appendix 3),or breastfeeding and at least one of the following conditions applies:
- The participant must provide (or legally acceptable representative if applicable) written informed consent for the trial.
Key exclusion criteria (25 listed)
- A WOCBP who has a positive serum or urine pregnancy test within 72 hours prior to first dose of pembrolizumab (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks [could consider shorter interval for kinase inhibitors or other short half-life drugs] prior to enrollment
- Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.
- Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KeytrudaPembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region. | Drug | Pembrolizumab + SBRT + Surgery |
| Stereotactic Body Radiation Therapy (5 days)8Gy x 3 (Mon-Fri) GTV+3mm | Radiation | Pembrolizumab + SBRT + Surgery |
| Surgical ResectionSurgical Resection of Tumor | Procedure or surgery | Pembrolizumab + SBRT + Surgery |
Primary outcome
To determine the pathologic response rate (MPR + pCR) at time of surgery
Time frame: 52 weeks
Prior to surgery neoadjuvant immunoradiotherapy (NIRT) with stereotactic body radiation therapy (SBRT) + pembrolizumab in stage III-IVA HPV-negative HNSCC patients.
10 secondary outcomes
Overall Response Rate
Time frame: 5 years
Clinical swallowing evaluation assessed by VFSS
Time frame: 5 years
Quality of Life assessed by PSS-HN
Time frame: 5 years
Quality of Life assessed by FACT-H&N
Time frame: 5 years
Quality of Life assessed by MDASI-HN
Time frame: 5 years
Quality of Life assessed by Eat-10
Time frame: 5 year
Quality of Life assessed by FOIS
Time frame: 5 years
Quality of Life assessed by UW-QOL
Time frame: 5 years
Adverse events
Time frame: From time of informed consent through 90 days after the last study treatment
Surgical Complications
Time frame: 30 days post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Bryan Bell, MD, DDS, FACS principal investigator
Providence Health & Services
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Stereotactic Body Radiation Therapy (5 days) and Surgical Resection in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Providence Health & Services at 3 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 13 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
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?
To determine the pathologic response rate (MPR + pCR) at time of surgery (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2026.