Last updated 7 months ago
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
864 patients around the world
Available in Brazil, Argentina, Mexico, United States
GlaxoSmithKline
4Research sites
864Patients around the world
This study is for people with
Head and neck cancer
Squamous cell carcinoma of the head and neck
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Participants are eligible to be included in the study only if all of the following criteria apply.Has newly diagnosed unresected LA histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and completed cisplatin plus radiotherapy with curative intent and has no evidence of distant metastatic disease.Has provided acceptable core or excisional tissue demonstrating.PD-L1 positive tumor status.If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 IHC testing.Has an Eastern Cooperative Oncology Group performance status of 0 or 1.Has adequate organ function.
- Participants are excluded from the study if any of the following criteria apply.Has received prior radiation therapy, systemic therapy, targeted therapy, or radical surgery for management of head and neck cancer not considered part of CRT.Has cancer outside of the oropharynx, larynx, hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer.Has experienced any of the following with prior immunotherapy: any irAE of Grade ≥3, immune-related severe neurologic events of any grade, exfoliative dermatitis of any grade, or myocarditis of any grade. (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade [Stevens-Johnson Syndrome, toxic epidermal necrolysis, or DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) syndrome], or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary.Has undergone any major surgical procedure or experienced significant traumatic injury within 28 days prior to enrolment.Has any history of interstitial lung disease or pneumonitis.Has cirrhosis or current unstable liver biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate.Is receiving any other anticancer or experimental therapy.Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or coinhibitory T-cell receptor.Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study.Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab or its excipients.
Sites
STAT Research - CABA
Recruiting
Sanatorio de la Mujer - Rosario
Recruiting
Fundación Respirar
Recruiting
Hospital General de Agudos Dra. Cecilia Grierson
Recruiting
StudyJADE
SponsorGlaxoSmithKline
Conditions
Squamous cell carcinoma of the head and neck
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06256588
