"QUAD SHOT" Radiotherapy With Pembrolizumab in Patients With Recurrent Head & Neck Cancer (NCT04373642) | Clinical Trial Compass
Active — Not RecruitingPhase 2
"QUAD SHOT" Radiotherapy With Pembrolizumab in Patients With Recurrent Head & Neck Cancer
United States30 participantsStarted 2020-12-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✕. 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)