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

StatusRecruiting
PhasePhase 1
Started2022-05-12
View on ClinicalTrials.gov ↗

Amendment history

2026-07-23
Suspended→Recruiting Study Status, Contacts/Locations v11
Trial statusSuspended→Recruiting
Reason stoppedIRB Approval Expiration→not stated
Study sitesdetails revised at 1 of 1 site
2026-07-08
Study Status, Contacts/Locations v10
Recruitment suspended
Reason stopped changed: — → IRB Approval Expiration
Study sitesdetails revised at 1 of 1 site
2026-01-29
Study Status, Oversight v9
Primary completion date2025-12-31→2026-12-31
Completion date2025-12-31→2026-12-31
2025-09-26
Suspended→Recruiting Study Status, Contacts/Locations v8
Trial statusSuspended→Recruiting
Reason stoppedIRB review expired→not stated
Study sitesdetails revised at 1 of 1 site
2025-07-03
Recruiting→Suspended Study Status, Contacts/Locations v7
Trial statusRecruiting→Suspended
Reason stoppednot stated→IRB review expired
Study sitesdetails revised at 1 of 1 site
Show 6 earlier versions
2025-03-13
Study Status, Oversight v6
Primary completion date2024-12-31→2025-12-31
2024-05-20
Study Status, Eligibility v5
Eligibility criteria-18 characters
[...] ancy test for females of reproductive potential Patients who plan to or have undergone therapy for their cancer, such as surgery an [...] imaging (MRI) per RECIST 1.1 criteria. Prior definitive and pallativepalliative chemotherapy will be allowed Prior radiation therapy will b [...] ll be instructed to adhere to contraception for a period of 31four weeksmonths after the last dose of investigational product Exclusion Cr [...] history of hypersensitivity to any of the trial medications or solutions they are mixed into Poorly controlled or serious medical or psychiatric illness [...] rcerated Patients not available for fol [...]
2024-01-09
Study Status, Study Description, Eligibility v4
Eligibility criteria-220 characters
[...] computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Prior definitive and pallative chemotherapy will be allowed Prior radiation therapy will b [...] transferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional ULN (obtained within 14 days of randomization) Total Bilirubin =< 1.5 x institutional ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) (obtained within 14 days of randomization) Women of childbearing potential (WOCBP) must use appropriat [...] WOCBP should use an adequate method to avoid pregnancy for 23four weeks (30 [...] [...]
Study description+23 characters
[...] o compare the overall survival (OS) of pembrolizumab and pre and post-operative external beam radiation therapy (EBRT) plus intra [...] t HNSCC. V. To assess the overall safety and tolerability of pre-operative pembrolizumab and pre-operative EBRT and IORT plus post-ope [...]
2022-12-01
Study Status v3
Start dateestimated 2022-05-01→confirmed 2022-05-12
2022-03-01
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2022-02-01→2022-05-01
Study description+13 characters
[...] er (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) and QLQ-HN35. EXPLORATORY OBJECTIVES: I. To evaluate associations betwee [...]
Study sitesdetails revised at 1 of 1 site
Study title-38 characters
PembrolizumabCombining andImmunotherapy Radiation Therapy Before and DuringSalvage Surgery for& theIORT Treatment ofTx Persistent or /Recurrent Head and& Neck Cancer
2021-12-16
Study Status v1
Start date2021-03-01→2022-02-01
2021-02-09
Original filing
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.
Trial Details
NCT Number NCT04754321
Lead Sponsor Ohio State University Comprehensive Cancer Center
Conditions 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
Enrollment 45 participants
Start Date 2022-05-12
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-24