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Clinical Trials in India / NCT06256588
Recruiting Phase 3

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

NCT06256588 · tracked via the Priya Life Science India tracker
Sponsor
GlaxoSmithKline
Phase
Phase 3
Started
2024-03-21
Last updated
2026-05-26

Condition(s) studied

Neoplasms, Head and Neck

Investigational drug(s) / intervention(s)

DostarlimabPlacebo

Dostarlimab: Dostarlimab will be administered as an intravenous (IV) infusion

Placebo: Placebo will be administered as an IV infusion

Study summary

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (277)

FacilityCityRegionStatus
GSK Investigational Site Jonesboro Arkansas Recruiting
GSK Investigational Site Los Angeles California Recruiting
GSK Investigational Site Solvang California Recruiting
GSK Investigational Site Stockton California Recruiting
GSK Investigational Site Torrance California Recruiting
GSK Investigational Site Farmington Connecticut Recruiting
GSK Investigational Site New Haven Connecticut Recruiting
GSK Investigational Site Washington D.C. District of Columbia Recruiting
GSK Investigational Site St. Petersburg Florida Recruiting
GSK Investigational Site Tamarac Florida Withdrawn
GSK Investigational Site Atlanta Georgia Recruiting
GSK Investigational Site Fort Wayne Indiana Recruiting
GSK Investigational Site Iowa City Iowa Recruiting
GSK Investigational Site Lexington Kentucky Recruiting
GSK Investigational Site Columbia Maryland Recruiting
GSK Investigational Site Worcester Massachusetts Recruiting
GSK Investigational Site St Louis Missouri Recruiting
GSK Investigational Site Omaha Nebraska Recruiting
GSK Investigational Site New York New York Completed
GSK Investigational Site The Bronx New York Recruiting
GSK Investigational Site Canton Ohio Recruiting
GSK Investigational Site Cincinnati Ohio Completed
GSK Investigational Site Tulsa Oklahoma Recruiting
GSK Investigational Site Philadelphia Pennsylvania Recruiting
GSK Investigational Site Pittsburgh Pennsylvania Recruiting
GSK Investigational Site Charleston South Carolina Recruiting
GSK Investigational Site Greenville South Carolina Completed
GSK Investigational Site Chattanooga Tennessee Recruiting
GSK Investigational Site Germantown Tennessee Recruiting
GSK Investigational Site Nashville Tennessee Recruiting
GSK Investigational Site Dallas Texas Recruiting
GSK Investigational Site Fort Worth Texas Recruiting
GSK Investigational Site San Antonio Texas Recruiting
GSK Investigational Site Fredericksburg Virginia Recruiting
GSK Investigational Site Wytheville Virginia Recruiting
GSK Investigational Site Tacoma Washington Withdrawn
GSK Investigational Site Buenos Aires Argentina Recruiting
GSK Investigational Site Buenos Aires Argentina Recruiting
GSK Investigational Site Buenos Aires Argentina Recruiting
GSK Investigational Site Ciudad Autonoma de Buenos Aire Argentina Recruiting

+ 237 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06256588 on ClinicalTrials.gov ↗ ← All trials in India