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
Advanced and/or metastatic solid tumors including the following: histologically or cytologically confirmed diagnosis of Stage IIIB not amenable to curative treatment or Stage IV non-small cell lung cancer (pemetrexed-platinum treatment groups must have nonsquamous histology type); and histologically or cytologically confirmed diagnosis of advanced/metastatic unresectable malignant pleural mesothelioma.
Measurable or nonmeasurable tumor lesions per RECIST v1.1.
Eastern Cooperative Oncology Group performance status 0 to 1.
You may not be if
Received prior treatment with checkpoint inhibitor agents (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4).
Had major surgery within 3 weeks before the first dose of study treatment.
Received radiation therapy to the lung(s) that is \> 30 Gy within 6 months of the first dose of study treatment.
Received palliative radiotherapy within 7 days before the first dose of study treatment.
Has ≥ Grade 2 residual toxicities from the most recent prior therapy (except alopecia).
Organ function (renal, hepatic), bone marrow reserve, and coagulation panel outside the protocol-defined laboratory values.
Is currently participating and receiving investigational therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks before the first dose of study treatment.
Has active autoimmune disease requiring systemic immunosuppression with corticosteroids (\> 10 mg once daily of prednisone or equivalent) or immunosuppressive drugs within 2 years before the first dose of study treatment.
Is on chronic systemic steroids (\> 10 mg once daily of prednisone or equivalent).
Known active central nervous system metastases and/or carcinomatous meningitis (patients with previously-treated and clinically stable brain metastases are eligible and a washout period of ≥ 4 weeks since radiation therapy is required).
Known additional malignancy that is progressing or requires active treatment.
Evidence of interstitial lung disease or active, noninfectious pneumonitis.
History of organ transplant, including allogeneic stem cell transplantation.
Active infections requiring systemic antibiotics.
Known active hepatitis B or C.
Has a diagnosis of immunodeficiency, including participants known to be HIV positive (positive for HIV 1/2 antibodies).
Significant cardiac event within 6 months before Cycle 1 Day 1.
Has received a live vaccine within 28 days of the planned start of study treatment.
Known hypersensitivity to any component of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
Clareo Health | INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
