Signed informed consent prior to study specific procedures. Signed informed consent prior to the performance of any study-specific procedures, including fresh tumor biopsies. Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures. Signed written informed consent granted prior to initiation of any study-specific procedures. Provide signed, written informed consent prior to the initiation of any study-specific procedures The patient has signed informed consent prior to initiation of any study-specific procedures or treatment. Patient must give study-specific informed consent on an IRB-approved consent prior to any research-related procedures or study treatment. The patient has not signed a study-specific informed consent for this study. Signed, informed consent must be obtained prior to any study specific procedures Have signed an informed document prior to any study-specific procedures or treatment Signed study-specific informed consent Signed informed consent obtained prior to initiation of any study-specific procedures and treatment; Signed, informed consent must be obtained prior to any study specific procedures Ability to understand and the willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures Written informed consent/assent prior to any study-specific procedures Signed written informed consent granted prior to initiation of any study-specific procedures Signed informed consent prior to the start of any study specific procedures. Subject understood and signed the study specific informed consent Ability to understand and willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures Signed informed consent prior to the start of any study specific procedures. Signed informed consent prior to initiation of any study-specific procedure or treatment Signed study-specific informed consent prior to study entry Signed study-specific informed consent form prior to study entry Signed study-specific informed consent prior to study entry Signed informed consent before initiation of any study procedures. Ability to sign informed consent form; informed consent form for this study must be signed prior to the performance of any study-specific procedures and initiation of any study therapy The patient has signed informed consent prior to initiation of any study-specific procedures or treatment. The patient has signed informed consent prior to initiation of any study-specific procedures or treatment. Signed study-specific informed consent Signed written informed consent before performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements (inclusive of 2 biopsies, one at baseline and if they qualify, one pre-randomization for part 2B) Signed informed consent prior to any protocol-specific procedures Ability to understand and the willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures The patient has signed informed consent prior to initiation of any study-specific procedures or treatment. Provided informed consent prior to initiation of any study-specific activities/procedures Ability to understand and the willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures Signed, informed consent must be obtained prior to any study specific procedures Signed, informed consent must be obtained prior to any study specific procedures. Signed informed consent prior to the start of any study specific procedures. Signed a protocol-specific informed consent Signed, informed consent must be obtained prior to any study specific procedures. Signed study-specific informed consent Have given written informed consent prior to any study-specific procedures Have given written informed consent prior to any study-specific procedures Signed study-specific informed consent Signed written informed consent granted prior to initiation of any study-specific procedures Have signed an informed document prior to any study-specific procedures or treatment Ability to understand and the willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures Signed study-specific informed consent prior to registration Ability to understand and willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures. Written informed consent before any study-specific procedure is performed Informed consent given prior to study-specific screening procedures Have signed written informed consent prior to the initiation of any study-specific procedures A signed informed consent must be obtained prior to any study-specific procedures. Written informed consent prior to completing any study-specific procedure Signed written informed consent from either the subject, or their legally acceptable representative if the subject is incapable of giving their own consent, prior to performing any study-specific tests or procedures. Give written informed consent prior to any study-specific procedures. Willing and able to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures Ability to understand and to sign an informed consent form; a signed informed consent must be obtained prior to any study specific procedures Before any study-specific procedure is performed, the appropriate written informed consent must be obtained Must give study specific informed consent prior to enrollment. For re-administration, patients must be re-consented. Ability to understand and the willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures Written informed consent before any study-specific procedure is performed Subjects must give written informed consent to participate in study. Consent must be obtained prior to the performance of any study-specific, non-institutional standard procedures. A copy of the signed informed consent will be retained in the subject's chart. Signed a study-specific informed consent prior to study entry Signed study-specific informed consent prior to registration Signed, specific informed consent prior to study entry Signed, specific informed consent prior to study entry Valid written informed consent signed by the patient prior to any study-specific procedures Ability to understand and the willingness to sign a written informed consent. A signed informed consent, including consent for biomarker analyses, must be obtained prior to any study-specific procedures Signed informed consent prior to any protocol-specific procedures