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 not be if
Measurable disease per RECIST v1.1.
Eastern Cooperative Oncology Group performance status 0 to 1.
Willingness to avoid pregnancy or fathering children.
Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug.
Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be acceptable with prior approval from the medical monitor).
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.
Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor.
Has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
Laboratory values outside the protocol-defined range at screening.
Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry.
Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\> 10 mg of prednisone or equivalent).
Evidence of interstitial lung disease or active noninfectious pneumonitis.
Known active central nervous system metastases and/or carcinomatous meningitis.
Known active hepatitis B antigen, hepatitis B virus, or hepatitis C virus infection.
Active infections requiring systemic therapy.
Known to be HIV-positive, unless all of the following criteria are met: CD4+ count ≥ 300/μL, undetectable viral load, receiving antiretroviral therapy.
Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
Impaired cardiac function or clinically significant cardiac disease.
Is pregnant or breastfeeding.
Has received a live vaccine within 28 days of the planned start of study drug.