EAY191: ComboMATCH

Summary

Patients with solid tumors who have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.

To be included in EAY191: ComboMATCH, participants must be / have

• Measurable disease.
• An ECOG performance status between 0 – 2, OR Lansky performance status of ≥ 50% OR Karnofsky performance status of ≥ 50%.
• Sequencing results available from an NCI credentialed Designated Laboratory (DL).
• 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.
• 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.

To be included in EAY191: ComboMATCH, participants must not be / have

• N/A

Keywords

Genetic markers; Tumors