Testing Dostarlimab against a placebo for head and neck neoplasms

Exclusion

• −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.
• −Participants are excluded from the study if any of the following criteria apply:
• −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 undergone any major surgical procedure or experienced significant traumatic injury that has not resolved by the time of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
• −Has any history of interstitial lung disease or pneumonitis (past or current).
• −Has cirrhosis of any stage or current unstable liver biliary disease per investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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.
• −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 VisitScreeningThe checks done before joining, to see whether a study fits.Read more → through 120 days after the last dose of study intervention.
• −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 experienced any of the following with prior immunotherapy: any immune-related adverse eventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (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.
• −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.