At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Dostarlimab (drug), Placebo (drug)
- How long the study runs
- Study runs about 67 months (dates as stated)
- About the drug or intervention
- Dostarlimab — drug: Dostarlimab will be administered as an intravenous (IV) infusion · Placebo — drug: Placebo will be administered as an IV infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 864
- Started
- 2024-03-21
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for neoplasms, head and neck
- • Phase3 - 864 participants
- • 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 take part?
- • Ages 18 Years and over
- • Diagnosed with neoplasms, head and neck
Where?
- • Edinburgh - GSK Investigational Site
- • Gloucester - GSK Investigational Site
- • London - GSK Investigational Site
- • Nottingham - GSK Investigational Site
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ p16 immunohistochemistry (IHC) testing
What the study is looking for
- ✓Participants are eligible to be included in the study only if all of the following criteria apply:
- ✓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 activity scale (ECOG) performance status of 0 or 1
Who cannot take part
- ✗Participants are excluded from the study if any of the following criteria apply:
- ✗Has undergone any major surgical procedure or experienced significant traumatic injury that has not resolved by the...
- ✗Has any history of interstitial lung disease or pneumonitis (past or current).
- ✗Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study, starting...
- ✗Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion...
See the full criteria
Where Is This Study? (6 UK sites)
GSK Investigational Site
Edinburgh EH4 2XU, United Kingdom
GSK Investigational Site
Gloucester GL1 3NN, United Kingdom
GSK Investigational Site
London SW3 6JJ, United Kingdom
GSK Investigational Site
Nottingham NG5 1PB, United Kingdom
GSK Investigational Site
Sutton SM2 5PT, United Kingdom
GSK Investigational Site
Wolverhampton WV10 0QP, United Kingdom
How to Get in Touch
US GSK Clinical Trials Call Center
Sponsor contactCONTACT
EU GSK Clinical Trials Call Center
Sponsor contactCONTACT
