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Head and Neck CancerPhase 2QUADSHOTNCT04373642

"QUAD SHOT" Radiotherapy With Pembrolizumab in Patients With Recurrent Head & Neck Cancer

A Phase 2 study testing Pebrolizumab + QUADSHOT Radiotherapy in people with Head and Neck Cancer, run by University of Oklahoma at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to test the safety of palliative "QUAD SHOT" radiotherapy combined with pembrolizumab and evaluate the effects of the combination treatment patients with recurrent cancer of head and neck. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Pebrolizumab + QUADSHOT Radiotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
23 Dec 2020to Oct 2026
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

  • Age 18 years and older
  • Written informed consent and any locally-required authorization obtained from the patients prior to performing any protocol-related procedures, including screening evaluations
  • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck (nasopharynx, oral cavity, oropharynx, hypopharynx, larynx, or unknown primary).
  • Locally recurrent or metastatic HNSCC not deemed amenable to curative-intent salvage therapy, in whom at least six months have passed since their prior RT, if received.
  • Must have evaluable lesion per RECIST v1.1
  • Patients agree to provide their smoking history prior to registration
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  • ECOG performance status of 0-2
  • Adequate bone marrow: absolute neutrophil count ≥ 1,500/μl, platelets ≥ 100,000/μl, hemoglobin ≥ 9 g/dL
  • Adequate hepatic function: total bilirubin ≤ 1.5 X upper normal limit (UNL) (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl), aspartate aminotransferase (AST) ≤ 2.5 X UNL, alanine aminotransferase (ALT) ≤ 2.5 X UNL
  • Adequate renal function: calculated serum creatinine clearance >40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection or Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN)
  • Female patients of reproductive potential and their male partners must agree to practice total abstinence or use a highly effective method of contraception (failure rate < 1% per year) prior to study entry, during treatment and for 90 days following the last dose of study treatment.
  • Male patient agrees to use an adequate method of contraception

Who cannot join

  • Histologically confirmed other types (Non-SCC) of salivary gland cancer
  • History of another primary malignancy EXCEPT For:
  • malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence;
  • adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease (eg, carcinoma in situ of the breast, oral cavity and cervix are all permissible);
  • low to favorable intermediate risk prostate cancer based on NCCN criteria on active surveillance, .
  • Prior radiotherapy to the region of the study cancer within less than 6 months
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  • Patients who have received prior radiation therapy and who, in the opinion of the treating radiation oncologist, cannot be reirradiated safely without excess risk of severe toxicity given prior radiation dose to critical structures.
  • Patients with known contraindications to radiotherapy, including inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., Ataxia-Telangiectasia, Nijmegen Breakage Syndrome)
  • Patients with inadequate renal function or other contraindications to IV contrast
  • Any previous treatment with PD-1 or PD-L1 inhibitors, including pembrolizumab
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of pembrolizumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
  • Any unresolved toxicity (>CTCAE grade 2) from previous anti-cancer therapy
  • Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
  • Active or prior documented autoimmune disease within the past 2 years (subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded)
  • Patients with evidence of interstitial lung disease or active, non-infectious pneumonitis
  • History of primary immunodeficiency
  • History of allogeneic organ transplant
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Known history of active infection including tuberculosis
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of pembrolizumab.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: A Single-arm Phase II Trial of Palliative "QUAD SHOT" Radiotherapy Combined With Pembrolizumab in Patients With Recurrent Head & Neck Cancer

The purpose of this study is to test the safety of palliative "QUAD SHOT" radiotherapy combined with pembrolizumab and evaluate the effects of the combination treatment patients with recurrent cancer of head and neck.

Read the detailed description

During this study, patients will receive infusions of pembrolizumab with radiotherapy (palliative QUADSHOT regimen). The patient will receive treatment of pembrolizumab once every 3 weeks and palliative "QUAD SHOT" radiotherapy every 4 weeks. These 28 day period of time is called a cycle. The cycle will be repeated 3 times. Each cycle is numbered in order. The patient will be treated for up to 3 cycles followed by pembrolizumab single drug until unacceptable toxicity or tumor progression.

The patient will also complete a survey.

Total duration of the study is up to two years.

Being tested
Pebrolizumab + QUADSHOT Radiotherapy
Keywords
QUADSHOT, Head and Neck Cancer, Pembrolizumab
Medical subject headings
Head and Neck Neoplasms

What participants receive

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

  • Pebrolizumab + QUADSHOT RadiotherapyDrug

    Treatment will consist of "QUAD SHOT" radiotherapy combined with pembrolizumab.

Study groups in NCT04373642
Study groupRoleWhat they receive
Pembrolizumab + QUADSHOT RadiotherapyExperimentalCombination Treatment * Pembrolizumab by IV once on day 1 of 21 day cycle, begin 7 days before the first round of QUAD SHOT radiotherapy. * QUAD SHOT radiotherapy twice a day for two days, begin 7 days after the first dose of pembrolizumab; repeat every 28 days for up to 3 rounds. Maintenance Treatment * Pembrolizumab by IV once on day 1 of 21 day cycle * On day 21, if the medical oncologist feels that the patient may safely continue treatment, patient will receive a new 21 days cycle of treatment with pebrolizumab.
Receives: Drug: Pebrolizumab + QUADSHOT Radiotherapy

What is being measured

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

  1. Tumor Response Rate

    Measured: up to 2 years

  2. Health-Related Quality of Life Questionnaire

    Measured: up to 2 years

Secondary outcomes (5)

  1. Overall Survival

    Measured: up to 2 years

  2. Progression Free Survival

    Measured: 6 months

  3. Progression Free Survival

    Measured: 12 months

  4. Incidence of post treatment toxicities

    Measured: up to 2 years

  5. Duration of Response

    Measured: up to 2 years

Timeline

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

  1. First posted4 May 2020
  2. Study start23 Dec 2020
  3. Primary completion14 Oct 2025
  4. Study completionOct 2026 (estimated)

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04373642
Sponsor's protocol ID
OU-SCC-QUADSHOT
Acronym
QUADSHOT
Status last verified
May 2026
First submitted
24 Apr 2020
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pebrolizumab + QUADSHOT Radiotherapy in people with Head and Neck Cancer, run by University of Oklahoma at 1 site 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 12 inclusion and 26 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 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Tumor Response Rate (time frame: up to 2 years). The study lists 2 primary outcomes in all. 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 NCT04373642.

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 11 May 2026.

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