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Recruiting Phase 3 NCT06256588

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Phase 3 – large-scale trial before approval
Conditions: Neoplasms, Head and Neck

Sponsor: GlaxoSmithKline

trial.available_in: БГ
Overview
The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with Head and Neck Squamous Cell Carcinoma (HNSCC)
Who can participate
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Has newly diagnosed unresected Locally Advanced (LA) histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and completed cisplatin plus radiotherapy (termed "CRT" in this protocol) with curative intent and has no evidence of distant metastatic disease. * Has provided acceptable core or excisional biopsy obtained prior to CRT: * PD-L1 positive tumor status * If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 immunohistochemistry (IHC) testing. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Has adequate organ function. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Has received prior radiation therapy (RT), systemic therapy, targeted therapy, or surgery for management of head and neck cancer not considered part of CRT. Participants receiving induction chemotherapy are excluded. CRT combinations with components other than cisplatin and RT (e.g., experimental agents, including radiosensitizers/radioprotectants, cetuximab) are not eligible. * 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 more than one primary HNSCC tumor. * Has experienced any of the following with prior immunotherapy: any immune-related adverse event (irAE) of Grade ≥3, immune-related severe neurologic events 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 Drug Rash with Eosinophilia and Systemic Symptoms \[DRESS\] 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 that has not resolved by the time of randomization. * Has any history of interstitial lung disease or pneumonitis (past or current). * Has cirrhosis of any stage 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, in the opinion of the investigator. * Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention. * 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 \[e.g., Cytotoxic T-lymphocyte associated protein 4 (CTLA4), OX-40, CD137\] * Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention. * 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.
Locations 26
Argentina (1)
GSK Investigational Site
Buenos Aires
US GSK Clinical Trials Call Center
Australia (1)
GSK Investigational Site
Blacktown , New South Wales
US GSK Clinical Trials Call Center
Belgium (1)
GSK Investigational Site
Brussels
US GSK Clinical Trials Call Center
Brazil (1)
GSK Investigational Site
Barretos
US GSK Clinical Trials Call Center
Canada (1)
GSK Investigational Site
Hamilton , Ontario
US GSK Clinical Trials Call Center
China (1)
GSK Investigational Site
Chongqing , Chongqing Municipality
US GSK Clinical Trials Call Center
Czech Republic (1)
GSK Investigational Site
Olomouc
US GSK Clinical Trials Call Center
France (1)
GSK Investigational Site
Caen
US GSK Clinical Trials Call Center
Germany (1)
GSK Investigational Site
Augsburg
US GSK Clinical Trials Call Center
Greece (1)
GSK Investigational Site
Athens
US GSK Clinical Trials Call Center
Hungary (1)
GSK Investigational Site
Győr
US GSK Clinical Trials Call Center
India (1)
GSK Investigational Site
Bengaluru
US GSK Clinical Trials Call Center
Israel (1)
GSK Investigational Site
Ashdod
US GSK Clinical Trials Call Center
Italy (1)
GSK Investigational Site
Bologna
US GSK Clinical Trials Call Center
Japan (1)
GSK Investigational Site
Aichi
US GSK Clinical Trials Call Center
Mexico (1)
GSK Investigational Site
Guadalajara
US GSK Clinical Trials Call Center
Norway (1)
GSK Investigational Site
Bergen
US GSK Clinical Trials Call Center
Poland (1)
GSK Investigational Site
Bielsko-Biala
US GSK Clinical Trials Call Center
Romania (1)
GSK Investigational Site
Bucharest
US GSK Clinical Trials Call Center
South Korea (1)
GSK Investigational Site
Busan
US GSK Clinical Trials Call Center
Spain (1)
GSK Investigational Site
BaracaldoVizcaya
US GSK Clinical Trials Call Center
Sweden (1)
GSK Investigational Site
Gothenburg
US GSK Clinical Trials Call Center
Taiwan (1)
GSK Investigational Site
Changhua
US GSK Clinical Trials Call Center
Turkey (1)
GSK Investigational Site
Adapazarı
US GSK Clinical Trials Call Center
United Kingdom (1)
GSK Investigational Site
Edinburgh
US GSK Clinical Trials Call Center
United States (1)
GSK Investigational Site
Jonesboro , Arkansas
US GSK Clinical Trials Call Center
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
21.03.2024
Completion date
26.10.2029
Registry ID
NCT06256588
Source
anzctr
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