RECRUITING

Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer

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Conditions

Head and Neck Carcinoma of Unknown PrimaryLocally Recurrent Head and Neck Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Pharyngeal Squamous Cell CarcinomaResectable Head and Neck Squamous Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy before and during surgery may kill more tumor cells.

Official Title

HNSALV Trial: Combining Immunotherapy With Salvage Surgery and IORT for Treatment of Persistent/Recurrent Head and Neck Cancers

Quick Facts

Study Start:2022-05-12
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04754321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically confirmed either persistent and/ or locoregionally recurrent HNSCC of oral cavity, pharynx, larynx, unknown primary head and neck (H\&N) squamous cell carcinoma
  2. * Resectable disease as determined by the surgeon and team
  3. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) \< 2
  4. * At least 18 years of age
  5. * Adequate hematologic, renal, and hepatic function
  6. * Must have at least 2 week washout period from prior therapy
  7. * Willingness and ability to provide informed consent
  8. * Negative pregnancy test for females of reproductive potential
  9. * Patients who have undergone therapy for their cancer, such as surgery and/or chemotherapy and/or radiotherapy and recurred
  10. * Disease measurable by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria.
  11. * Prior definitive and palliative chemotherapy will be allowed
  12. * Prior radiation therapy will be allowed
  13. * Tumor tissue from resected site of disease must be provided for biomarker analyses, in addition to urine and blood sample as scheduled per protocol
  14. * White blood cell (WBC) \>= 2000/uL (obtained within 14 days of randomization)
  15. * Neutrophils \>= 1500/uL (obtained within 14 days of randomization)
  16. * Platelets \>= 100 x10\^3/uL (obtained within 14 days of randomization)
  17. * Hemoglobin \> 9.0 g/dL (obtained within 14 days of randomization)
  18. * Serum creatinine =\< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) \>= 40 mL/min (Cockcroft and Gault or Wright formula may be used according to local practice) (obtained within 14 days of randomization)
  19. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional ULN
  20. * Total Bilirubin =\< 1.5 x institutional ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
  21. * Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for four months after the last dose of pembrolizumab.
  22. * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\])
  23. * Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of four months after the last dose of investigational product
  1. * Requirement of immunosuppressive therapy within 14 days of randomization
  2. * Salivary gland carcinomas, lip carcinoma, adenocarcinoma of the skin
  3. * Prior use of immune checkpoint blockade agent
  4. * History of human immunodeficiency virus (HIV), hepatitis B, C: Participants who test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection, those who test positive for human immunodeficiency virus (HIV) or have known acquired immunodeficiency syndrome (AIDS)
  5. * Unresectable disease, as determined by the surgeon and team
  6. * Subjects with history of grade 3 toxicity with prior immunotherapy
  7. * Patients with distant metastases
  8. * Subjects with active autoimmune disease
  9. * Breastfeeding women
  10. * Additional prior malignancy within the previous 3 years (treated or untreated, except for skin carcinomas treated with excision alone and carcinoma in situ of the cervix)
  11. * Palliative radiotherapy less than 14 days prior to first dose of study drug
  12. * Any history of hypersensitivity to any of the trial medications
  13. * Poorly controlled or serious medical or psychiatric illness likely to interfere with participation and/or compliance in this clinical trial
  14. * Prisoners or subjects who are involuntarily incarcerated
  15. * Patients not available for follow-up/future contact as defined in the ICF
  16. * Note: Patients on this protocol are not excluded from participation in other clinical trials

Contacts and Locations

Study Contact

The Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Dukagjin M Blakaj, MD, PhD
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

  • Dukagjin M Blakaj, MD, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-12
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-05-12
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Carcinoma of Unknown Primary
  • Locally Recurrent Head and Neck Squamous Cell Carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Oral Cavity Squamous Cell Carcinoma
  • Recurrent Pharyngeal Squamous Cell Carcinoma
  • Resectable Head and Neck Squamous Cell Carcinoma