18 Years and up
Accepting Healthy Volunteers?
- Histologically proven, locally advanced unresectable or metastatic solid tumors for
whom no approved therapy with demonstrated clinical benefit is available or
participants who are intolerant to or have declined standard therapy
- Measurable or nonmeasurable tumor lesions per RECIST v 1.1.
- Willing to provide fresh or archival tumor tissue for correlative studies.
- Eastern Cooperative Oncology Group performance status 0 to 1.
- Willingness to avoid pregnancy or fathering children based on protocol-defined
- Receipt of anticancer therapy within 21 days of the first administration of study
treatment, with the exception of localized radiotherapy.
- Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the
exception of alopecia and anemia not requiring transfusional support).
- Laboratory values outside the protocol-defined range at screening.
- Active autoimmune disease requiring systemic immunosuppression in excess of
physiologic maintenance doses of corticosteroids.
- Known hypersensitivity to any of the study drugs, excipients, or another monoclonal
antibody which cannot be controlled with standard measures (eg, antihistamines and
- Evidence of interstitial lung disease or active, noninfectious pneumonitis.