<qa>  What is a newly-obtained specimen defined as?- Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks 42 days prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided e.g. inaccessible or subject safety concern may submit an archived specimen only upon agreement from the Sponsor and primary investigator. 