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People eligible to participate in the FIERCE-HN study

Not actual patient

Not actual patient

People eligible to participate in the FIERCE-HN study

Inclusion criteria*

Male or female ≥18 years of age with histologically and/or cytologically confirmed primary diagnosis of R/M HNSCC
Participants with oropharyngeal cancer will be required to have proof of HPV-negative status submitted on the basis of a pathology report
At least 1 measurable lesion by contrast CT or MRI scan according to RECIST v.1.1. Such lesions must not have been previously irradiated; if the measurable lesion(s) has been irradiated, clear progression must be documented
Participants must have failed prior therapy with an anti-PD-1/PD-L1 ICI and with platinum-based chemotherapy administered in combination or sequentially, in either the locally advanced or R/M setting. Failure of prior treatment may be due to progression of disease or intolerance to treatment
ECOG performance status of 0 or 1 with a life expectancy of at least 12 weeks

Documentation of negative serum pregnancy test within 30 days of randomization for women of childbearing potential (WOCBP)

For WOCBP and male participants whose sexual partners are of childbearing potential, agreement to use an effective method of contraception during the study and for at least 60 days after the last dose of study treatment
Ability to give written informed consent and comply with protocol requirements
Participants with feeding tubes are eligible for the study
Archived tissue sample must be submitted to the Sponsor-designated laboratory within 60 days of randomization for cMet/HGF analysis

Exclusion criteria*

History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or cetuximab

Known 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
Prior treatment with any other investigational drug or biologic agent before a washout has been completed (must be completed prior to randomization):
  1. 2 weeks (14 days) or 5 half-lives, whichever is shorter, for chemotherapeutic agents, small molecules, and checkpoint inhibitors
  2. 3 weeks (21 days) or 5 half-lives, whichever is shorter, for antibody-drug conjugates
  3. 4 weeks (28 days) for cell therapies
Any unresolved and significant toxicity (NCI-CTCAE version 5.0) Grade >2 from previous anticancer therapy (including radiation therapy)
Significant cardiovascular disease, including: cardiac failure NYHA class III or IV; MI, severe or unstable angina within 6 months prior to randomization; history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation)
Any other medical condition or psychiatric condition that, in the opinion of the Investigator, 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)
Female participants who are pregnant or breastfeeding

*Full list of criteria can be found in the study protocol.
cMET/HGF, cellular mesenchymal-epithelial transition factor/hepatocyte growth factor; CT, computed tomography; ECOG, Eastern Cooperative Oncology Group; HPV, human papillomavirus; ICI, immune checkpoint inhibitor; MI, myocardial infarction; MRI, magnetic resonance imaging; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; NYHA, New York Heart Association; PD-1, programmed cell death protein 1; PD-L1, programmed death ligand 1; RECIST, response evaluation criteria in solid tumors.