Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

Exclusion Criteria

• •NEOADJUVANT PATIENTS: Subjects must be eligible based on investigator discretion to receive approved CPI therapy.
• •Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy.
• •Subjects who are Stage I, II, or III and have progressed to metastatic cannot have received any anti-cancer treatment for at least 2 - 4 weeks (depending upon the washout period of prior anti-cancer treatment) prior to biopsy as per the agents used.
• •ECOG Performance Status (PS) 0, 1 or 2.
• •Negative pregnancy test done ≤7 days prior to enrollment, for persons of childbearing potential only
• •Female subjects must not be pregnant or breastfeeding and must use appropriate methods of contraception when applicable.
• •Subjects must be clinically able, at investigator discretion, and willing to undergo either:
• •* additional biopsy passes during their standard of care biopsy, OR
• •* a biopsy for research only, if applicable.
• •* NOTE: These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to biopsies per the clinician.
• •Subjects with a known secondary cancer diagnosis are eligible to participate if participation does not interfere with systemic anti-cancer standard of care treatment for suspected primary diagnosis.
• •Provide written informed consent
• •Pregnant women because this study involves a greater than minimal risk procedure (biopsy)
• •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety for the biopsy
• •Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
• •* NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
• •Uncontrolled intercurrent illness including, but not limited to:
• •* ongoing or active infection
• •* psychiatric illness/social situations that would limit compliance with study requirements
• •Subjects who are enrolled or plan to be enrolled in a blinded cancer therapeutic treatment trial