Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SQZ Biotechnologies
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients ≥18 years of age
Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally or centrally, or based on documented historic test results)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
At least 1 measurable lesion according to RECIST 1.1
Must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at Screening and on Cycle 2 Day 8 (+/- 2 days)
Patients must agree to venous access for leukapheresis and be willing to have a central line inserted if venous access is an issue
Adequate organ function and bone marrow reserve performed within 14 days prior to leukapheresis
Patients must not have been treated with immune check-point inhibitors
You may not be if
Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to leukapheresis.
Systemic treatment with either corticosteroids (\>10 mg of prednisone or the equivalent per day) or other immunosuppressive medications within 14 days prior to leukapheresis
Patients treated with non-corticosteroid based immunosuppressive agents within the last 6 months prior to leukapheresis
Patients with active, known, or suspected autoimmune disease may not be eligible and should be discussed with the Sponsor
Patients with \>Grade 1 AEs related to previous treatment with anticancer or investigational therapy that do not resolve at least 2 weeks prior to leukapheresis, except Grade 2 neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement
Known HIV infection, active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
Has known active central nervous system metastases
Have active interstitial lung disease and any history of myocarditis
Major surgery within 2 weeks of leukapheresis
Known hypersensitivity to pembrolizumab
History of any Grade 3 immune-related AE (irAE) from prior immunotherapy
Prior treatment with an immune check-point inhibitor
