Clinical Trial TitleA phase 2 study of lenvatinib (E7080/MK-7902) with or without pembrolizumab (MK-3475) and SOC chemotherapy for R/M HNSCC after platinum therapy and immunotherapy
National Clinical Trial Number:NCT04428151
Clinical Trial Protocol Description:
This study is trying to find out if two research study drugs will work to slow down or stop the growth of head and neck squamous cell carcinoma. The study is also trying to find out what side effects patients may have when they take the one study drug alone and the two study drugs together. Researchers don’t know if these study drugs work to treat this type of cancer.
One drug being studied is called pembrolizumab (or MK-3475). It is a type of immunotherapy, which may help the body’s immune system attack cancer cells. The other drug being studied is called lenvatinib. It is a type of drug called an inhibitor, which may help to block cancer cells from growing.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histologically confirmed recurrent (not amenable to curative treatment with local and/or systemic therapies) or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and/or larynx that is considered incurable by local therapies.
- Have disease progression at any time during or after treatment with a platinum-containing (eg, carboplatin or cisplatin) regimen.
- Have disease progression on or after treatment with an anti-PD-1/PD-L1 mAb (programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody).
- Have pre-study imaging that demonstrates evidence of disease progression based on investigator review of at least 2 pre-study images per RECIST 1.1, following initiation of treatment with a PD-1/PD-L1 inhibitor.
You will be excluded from the study if any of the following criteria apply to you:
- Have carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors.
- Have disease that is suitable for local therapy administered with curative intent.
- Have life expectancy of less than 3 months and/or has rapidly progressing disease in the opinion of the treating investigator.
- Have a history of noninfectious pneumonitis that required systemic steroids, or current pneumonitis/interstitial lung disease.
- Have an active infection requiring systemic therapy.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Clinical Trial Investigator
RUSH University Medical Center
1620 W Harrison St
Chicago, IL 60612