Testing Ficlatuzumab against a placebo for metastatic head-and-neck squamous-cell carcinoma

Exclusion

• −History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or cetuximab
• −Known or suspected untreated and uncontrolled brain metastases or leptomeningeal carcinomatosis Note: Participants with locally treated brain metastases are eligible provided 2 weeks have elapsed since local therapy. Participants are allowed to continue steroid taper during the start of study treatment.
• −Participants who are positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) with indication of acute or chronic hepatitis (as defined in protocolProtocolThe detailed plan a study must follow.Read more →)
• −Participants who have received \> 2 prior lines of anticancer therapy or prior treatment with cetuximab/alternative EGFR inhibitors for the treatment of R/M HNSCC
• −2 weeks (14 days) or 5 half-lives, whichever is shorter, for chemotherapeutic agents, small molecules, and checkpoint inhibitors
• −3 weeks (21 days) or 5 half-lives, whichever is shorter, for antibody-drug conjugates
• −4 weeks (28 days) for cell therapies
• −Significant cardiovascular disease, including: Cardiac failure New York Heart Association class III or IV; Myocardial infarction, severe or unstable angina within 6 months prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →; History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
• −Any other medical condition or psychiatric condition that, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, might interfere with the participant's involvement in the study or interfere with the interpretation of study results
• −History of prior malignancy within 2 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early-stage prostate cancer, without evidence of recurrence; participants may or may not be on maintenance therapy)
• −Radiographic evidence (historical or at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →) of interstitial lung disease or idiopathic pulmonary fibrosis
• −A full list of inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → can be found in the protocol.
• −Female participants who are pregnant or breastfeeding
• −Prior treatment with any other investigational drug or biologic agent or radiation therapy before a washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → has been completed (must be completed prior to randomization):
• −2 weeks (14 days) for radiation therapy
• −Any unresolved and significant toxicity (National Cancer Institute Common Terminology Criteria for Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → \[NCI-CTCAE\] version 5.0) Grade 2 or greater from previous anticancer therapy (including radiation therapy), other than alopecia