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A Study of Dostarlimab for Head and Neck Squamous Cell Carcinoma

This study is testing Dostarlimab against a placebo (an inactive substance) in adults with newly diagnosed, locally advanced head and neck squamous cell carcinoma (HNSCC). This is a type of cancer that starts in the moist tissues lining the head and neck. Participants will have already completed chemoradiation (a combination of chemotherapy and radiation therapy). The main goal is to see if Dostarlimab can improve event-free survival (EFS), meaning how long participants live without the cancer returning or getting worse, over approximately five years. The study is currently recruiting and plans to enroll 864 participants. Dostarlimab works as an immunotherapy, targeting PD-L1.

Study design
This interventional study plans to enroll 864 adult participants. It compares Dostarlimab to a placebo, both given intravenously (into a vein).
What's involved
Participants will receive Dostarlimab or placebo as an intravenous infusion. The study will assess event-free survival for up to approximately 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for event-free survival for up to approximately 5 years.

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NCT06256588

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
GlaxoSmithKline
~864 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:DostarlimabPlacebo

At a glance

Recruiting sites
256 of 277 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
Measured over Up to approximately 5 years

Conditions

Neoplasms, Head and Neck

Explore related trials

Head and Neck Squamous Cell CarcinomaCDKN2A wt Allele

Where it's being run

277 sites across 61 states
China29
Japan27
Spain14
Brazil13
Argentina10
Italy10
Romania10
France9

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)Up to approximately 5 years

    Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event, where an event is defined as locoregional progression or recurrence, or distant metastasis per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as per BICR; Salvage surgery at the primary tumor site; Neck dissection or surgery performed \>20 weeks after completion of Concomitant Chemoradiotherapy (CRT) when invasive cancer is present or Death from any cause.