- Histological or cytological diagnosis of locally advanced or metastatic NSCLC or
urothelial carcinoma who have progressed on or were intolerant to standard of care
systemic therapy, or for whom standard of care systemic therapy was refused (refusal
must be documented) or unavailable.
- No prior treatment with anti-PD-1 or anti-PD-L1 therapy.
- NSCLC patients whose tumor is not known to have ALK or EGFR mutations must have
progressed on or after no more than 1 prior line of platinum-containing systemic
therapy or were intolerant or refused standard of care systemic therapy.
- NSCLC patients whose tumor is known to have ALK or EGFR mutation must have received
prior systemic therapies that only include 1 or more lines of ALK or EGFR targeting
drugs and chemotherapy limited to 1 line of a platinum-based regimen and they must
have progressed on or after both types of therapies.
- Urothelial carcinoma patients must have received up to 2 lines of prior systemic
therapy and progressed on or after, experienced disease recurrence within 12 months of
neoadjuvant or adjuvant treatment, were intolerant to, ineligible or refused
platinum-containing systemic therapy. If urothelial cancer patients are treatment
naïve and eligible for platinum-containing systemic therapy but are refusing platinum
chemotherapy, they must also be documented to have previous PD-L1 high status.
- Provide archived tumor tissue sample taken within the past 2 years or provide a fresh
tumor biopsy sample.
- At least one measurable lesion as defined by RECIST version 1.1.
- Adequate renal, liver, thyroid and bone marrow function.
- Performance status 0 or 1.
- Patient is capable of receiving study treatment for at least 8 weeks.
- Active brain or leptomeningeal metastases.
- Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes
mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone
replacement, psoriasis not requiring systemic treatment, or conditions not expected to
recur in the absence of an external trigger are permitted to enroll. Diagnosis of
prior immunodeficiency or organ transplant requiring immunosuppressive therapy or
prior allogeneic bone marrow or hematopoietic stem cell transplant.
- Patients with a condition requiring systemic treatment with either corticosteroids
(>10mg daily prednisone equivalents) or other immunosuppressive medications within 14
days of study drug administration. Inhaled or topical steroids, and adrenal
replacement doses >10 mg daily prednisone equivalents are permitted in the absence of
active autoimmune disease.
- Patients with a history of interstitial lung disease, non-infectious pneumonitis, or
active pulmonary tuberculosis. Those with active lung infections requiring treatment
are also excluded.
- History of Grade ?3 immune mediated AE (including AST/ALT elevations that where
considered drug related and cytokine release syndrome) that was considered related to
prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory
agents, etc.) and required immunosuppressive therapy.
- Active hepatitis B or C, HIV/AIDS.
- Other potentially metastatic malignancy within past 5 years.