Patients should have lesions that are safely accessible for biopsy and be willing to provide pre- treatment and on-treatment tissue biopsy. Fine -needle aspiration biopsy is not acceptable. Archival tumor tissue will be accepted in lieu of fresh bio psy at s creening if sample was collected within 6 -months from Cycle 1 Day 1, and the local pathologist confirms that an adequate amount of tissue/tumor cells exist to allow completion of all testing as outlined in the specimen collection m anual. 3.