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Looking for participantsPhase3

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

Sponsor: GlaxoSmithKline

NCT ID: NCT06256588

View on ClinicalTrials.gov ↗

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)

Neoplasms, Head and Neck

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

PD-L1L1 positiveCD137

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
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.

Where Is This Study? (6 UK sites)

GSK Investigational Site

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
David NoblePrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Gloucester GL1 3NN, United Kingdom

Recruiting
Site contact (verified)
Warren GrantPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Ben O'LearyPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Nottingham NG5 1PB, United Kingdom

Recruiting
Site contact (verified)
Judith ChristianPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Ben O'LearyPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Wolverhampton WV10 0QP, United Kingdom

WITHDRAWN

How to Get in Touch

US GSK Clinical Trials Call Center

Sponsor contact

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

Sponsor contact

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05