Protocol EAY191 Molecular Analysis for Combination Therapy Choice (ComboMATCH)

This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical
trials to study cancer treatment directed by genetic testing. Patients with solid tumors
that 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.

Inclusion Criteria:

- Patient must have measurable disease

- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status
between 0-2 OR patient must have Lansky performance status of >= 50% or Karnofsky
performance status of >= 50%

- Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as
assessed by the enrolling provider

- All patients must have sequencing results available from a National Cancer Institute
(NCI) credentialed Designated Laboratory (DL)

- Patients must have locally advanced or advanced histologically documented solid
tumors requiring therapy and meet one of the following criteria:

- Patients 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

- Patient must meet one of the following requirements:

- Patients 18 years and older 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 and older 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 meet the following criteria:

- Tissue must have been collected within 12 months prior to registration to
the EAY191 Registration Trial

- Patient must not have had a Response Evaluation Criteria in Solid Tumors
(RECIST) response (complete response [CR] or partial response [PR]) to any
intervening therapy after collection of the tissue

- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be
available OR

- Patients under 18 years old must confirm availability of an archival tumor
tissue specimen for submission for research if patient enrolls to a ComboMATCH
Treatment Trial. This tumor tissue must meet the following criteria:

- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be
available

- NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection
and management instructions. Performance of the mandatory research biopsy or
submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection
and submission of the blood specimens for the integrated studies will be
performed under the consent authority of the specific treatment trial protocol
to which the patient is registered. No procedures to collect specimens for
research only are to be performed for patients registered to the EAY191
Registration Trial only

- NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If
patient is found to not be eligible for the assigned ComboMATCH Treatment Trial,
indication of ineligibility will trigger re-evaluation and potential assignment to
another Treatment Trial