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

NCT04373642 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: OU-SCC-QUADSHOT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Keywords

QUADSHOT; Head and Neck Cancer; Pembrolizumab

Outcome Measures

Primary Outcomes (2)

• Tumor Response Rate

  up to 2 years

• Health-Related Quality of Life Questionnaire

  up to 2 years

Secondary Outcomes (5)

• Overall Survival

  up to 2 years

• Progression Free Survival

  6 months

• Progression Free Survival

  12 months

• Incidence of post treatment toxicities

  up to 2 years

• Duration of Response

  up to 2 years

Study Arms (1)

Pembrolizumab + QUADSHOT Radiotherapy

EXPERIMENTAL

Combination 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.

Drug: Pebrolizumab + QUADSHOT Radiotherapy

Interventions

Pebrolizumab + QUADSHOT Radiotherapy DRUG

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

Pembrolizumab + QUADSHOT Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Christina Henson, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 4, 2020
• Study Start: December 23, 2020
• Primary Completion: October 14, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)