Tests dostarlimab after chemoradiation in head and neck cancer
Tests dostarlimab against placebo in adults with head and neck squamous cell carcinoma.
Plain-language title generated from the registry record
Registry title: A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
Key facts
- Where
- Augsburg, Berlin, Erlangen, Essen, Giessen, Hamburg, and Straubing, GermanySee the 8 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed head and neck squamous cell carcinoma that cannot be removed by surgery and who have finished chemoradiation with cisplatin.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed locally advanced head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, not removed by surgery, with no distant spread.
- Earlier treatment
- Must have finished cisplatin plus radiotherapy with the aim of removing all of the disease. Prior immune checkpoint treatment (anti-PD-1, anti-PD-L1, anti-PD-L2 or similar) is not allowed.
- Biomarker or test result
- Tumour must be PD-L1 positive. For oropharyngeal cancer, p16 testing is needed.
Main reasons for not taking part
- Prior radiation, systemic, targeted therapy or surgery for head and neck cancer outside the chemoradiation
- Cancer of the nasopharynx, sinus or unknown primary site, or more than one primary tumour
- History of interstitial lung disease or pneumonitis
- Cirrhosis of any stage or unstable liver or bile duct disease
- Pregnant or breastfeeding, or planning to conceive during the study
Read by machine on 9 November 2026.
Where in Germany
- Universitaetsklinikum AugsburgAugsburg, GermanyNo longer taking part
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyNo longer taking part
- Vivantes Netzwerk fuer Gesundheit GmbHBerlin, GermanyNo longer taking part
- Universitaetsklinikum Erlangen AöRErlangen, GermanyNo longer taking part
- Universitaetsklinikum Essen (AoR)Essen, GermanyNo longer taking part
- Justus-Liebig-Universitaet GiessenGiessen, GermanyNo longer taking part
- Katholisches Marienkrankenhaus gGmbHHamburg, GermanyNo longer taking part
- Barmherzige Brueder gemeinnuetzige Traeger GmbHStraubing, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GlaxoSmithKline
- Trial code
- NCT06256588EU 2023-508613-17-00
- Record updated
- 26 May 2026
- Original description
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)Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
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)
Inclusion: 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: 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 undergone any major surgical procedure or experienced significant traumatic injury that has not resolved by the time of randomization; 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; 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 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 of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab or its excipients; 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 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; 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]; Participants are excluded from the study if any of the following criteria apply:; 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.