Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Incyte Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ability to comprehend and willingness to sign a written informed consent form.
Confirmed diagnosis of locally advanced or metastatic SCAC.
Must have received (or been intolerant to or ineligible for) at least 1 prior line of platinum-based chemotherapy and received no more than 2 prior systemic treatments.
Must have measurable disease by RECIST v1.1.
Eastern Cooperative Oncology Group performance status of 0 to 1.
If HIV-positive, then all of the following criteria must also be met: CD4+ count ≥ 300/μL, undetectable viral load, and receiving highly active antiretroviral therapy.
You may not be if
Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug; 6 weeks for mitomycin C.
Radiotherapy within 14 days of first dose of study treatment with the following caveats: 28 days for pelvic radiotherapy, 6 months for thoracic region radiotherapy that is \> 30 Gy.
Prior treatment with programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (PD-L1)-directed therapy.
Active autoimmune disease requiring systemic immunosuppression.
Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
Known active hepatitis infection.
Active infections requiring systemic therapy.
Is pregnant or breastfeeding or is expecting to conceive or father children within the projected duration of the study, from screening through 6 months after the last dose of study drug.
