EAY191: Molecular Analysis for Combination Therapy Choice (ComboMATCH)

• Must have measurable disease.
• Must have an ECOG performance status between 0 – 2, OR Lansky performance status of ≥ 50% OR Karnofsky performance status of ≥ 50%.
• Must have sequencing results available from an NCI credentialed Designated Laboratory (DL).
• Must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria:
  • Must have progressed on at least one line of standard systemic therapy. OR,
  • Patients whose disease has no standard treatment that has been shown to prolong overall survival.
• Must meet one of the following requirements:
  • Patients ≥18 years who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial. OR,
  • Patients ≥18 years who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial; must not have had a RECIST response (CR or PR) to any intervening therapy after collection of the tissue; FFPE tumor tissue block(s) or slides must be available. OR,
  • Patients <18 years old must confirm willingness to submit an archival tumor tissue specimen, if available, for research if the patient enrolls to a ComboMATCH Treatment Trial. FFPE tumor tissue block(s) or slides.

N/A