Testing Ficerafusp alfa against a placebo for metastatic head and neck squamous cell carcinoma

Exclusion

• −Prior history of Grade ≥2 intolerance or hypersensitivity reaction to anti-EGFR therapy or other murine proteins.
• −Known active central nervous system metastases, history of spinal cord compression from tumor involvement, a history of carcinomatous meningitis, or leptomeningeal disease are excluded.
• −Subjects with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment.
• −Subjects with a known history of hepatitis C virus (HCV) who have not completed curative antiviral treatment or have an HCV viral load above the limit of quantification at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
• −Known history of human immunodeficiency virus (HIV).
• −Disease suitable for local therapy administered with curative intent.
• −Prior treatment with anti-TGFβ therapy.
• −Prior therapy with an anti-EGFR antibody (exception: radio sensitizing agents and multimodal treatment for locoregionally advanced disease).
• −Prior therapy with an immune checkpoint inhibitor completed within 6 months prior to study treatment initiation.
• −Progressive disease \<6 months from completion of curative intent systemic therapy for locoregionally advanced HNSCC.
• −Life expectancy less than 3 months.
• −Current active major bleeding, or a recent major bleeding episode within 4 weeks prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
• −Subject participated in another clinical study or received treatment with another investigational drug must wait at least 5 half-lives of the treatment received or 4 weeks (whichever is shorter) following prior therapy.
• −Active autoimmune disease requiring systemic treatment in the past 2 years.
• −Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, with the exception of transplants that do not require immunosuppression.
• −Known to be diagnosed and/or treated for any other additional malignancy within 2 years prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer.
• −Any condition requiring systemic treatment with either corticosteroids (\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids.
• −Use of a live or live attenuated vaccine within 4 weeks prior to Screening.
• −Other InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply as defined in the protocolProtocolThe detailed plan a study must follow.Read more →.