Summary

This clinical trial determines whether an educationally enhanced genomic tumor board (EGTB) intervention increases the proportion of patients with solid tumor who receive genome-informed treatment for tumor that has come back after a period of improvement (recurrent), does not respond to treatment (refractory), has spread from where it started (primary site) to other places in the body (metastatic), or is newly diagnosed and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). This trial also aims to learn whether EGTB intervention increases doctors’ understanding of genomic tumor test results as well as their comfort level with genomic tumor tests. Genome-informed treatment refers to treatment based on the information found in genomic tumor test results. This study compares the usual approach in which physicians order genomic tumor test and review the results without the genomic board (GTB) involvement vs. when physicians receive guidance from genomic tumor board (GTB) after GTB reviews patients’ genomic test results. A GTB is team of doctors and scientists that have experience in understanding genomic changes. An educationally enhanced tumor board is a tumor board that provides additional training. The tumor board helps to suggest whether there are other cancer treatment options based on patient genetic test results.

Objectives

PRIMARY OBJECTIVE:
I. To determine whether an EGTB intervention compared to usual practice increases the proportion of patients who receive evidence-based genome-informed therapy within 6 months after registration to the study.

SECONDARY OBJECTIVES:
I. To compare physician genomic confidence and physician experience with genomic tumor testing (GTT) between arms at baseline and end of study.
II. To compare clinical outcomes between arms by assessing patient survival and time to treatment discontinuation.
III. To compare physician assessment of evidence-based genome-informed therapy to the central study team determination of evidence-based genome-informed therapy, both overall and separately by arm.

IMPLEMENTATION OBJECTIVES:
I. To assess the utilization of GTT and implementation of the EGTB intervention into clinic workflow in order to better understand barriers and facilitators at Recruitment Centers assigned to the active intervention arm using a mixed-methods approach.
II. To assess the evolution of GTT utilization within clinic workflows at Recruitment Centers assigned to the usual practice (control) arm using a mixed-methods approach.

OUTLINE: Study clinics are randomized to 1 of 2 arms. Participants receive interventions based on this randomization.

ARM 1: Participants receive usual care. This consists of physicians ordering GTT for patients and reviewing the results without the GTB being involved.

ARM 2: Patients and physicians receive the EGTB intervention. This is comprised of 2 components: the structured GTB and the supporting education. Physicians submit cases for discussion to the GTB within 2 weeks of GTT results. The GTB sessions are held weekly and conducted virtually over a video-conferencing platform. Each case presentation is 10 to 15 minutes long, and 4 to 9 cases are discussed during each 60 to 90 minute GTB session. GTT results and clinical data are presented and expert interpretation of genomic test results is provided to help prioritize potential treatment options and provide a framework for interpretation. Supporting education materials are also available online to participants to support GTT decision making.

Physicians are followed until the end of the study or through 6 months after their last patient was registered to the study, whichever is later. Patients are followed for 24 months after registration or until a criterion for removal from protocol participation is met, whichever comes first.

Eligibility

1. RECRUITMENT CENTERS INCLUSION
2. A Recruitment Center is defined as an outpatient clinic, or group of clinics, belonging to the same National Cancer Institute Community Oncology Research Program (NCORP) or minority/underserved (MU)-NCORP, that will be contributing physicians and patient participants to the study.
3. Recruitment Centers must be part of an NCORP or MU-NCORP site with Cancer Care Delivery Research (CCDR) funding. Each clinic included in the Recruitment Center must be associated with Cancer Therapy Evaluation Program (CTEP) institution identification (ID).
4. Recruitment Centers must order large panel next generation sequencing genomic tests on at least 10 unique patients per month.
5. Recruitment Centers must have at least 4 practicing oncologists (including medical, gynecologic, or neuro-oncologists) at the site willing to participate in the study and register within three months of study activation.
6. Recruitment Centers must be willing to register a total of 66 patients (over 2 years) to the study.
7. Recruitment Centers must be able to send at least one member of the clinical team to attend the Recruitment Center’s cases presented to the S2108CD Genomic Tumor Board, should the Recruitment Center be randomized to the intervention arm.
8. Recruitment Centers must be willing and able to document the number of unique patients for whom GTT were ordered at the Recruitment Center and submit this monthly via Rave (registered trademark).
9. Recruitment Centers must not have an existing Genomic Tumor Board. For the purposes of this study, a Genomic Tumor Board is defined as an interdisciplinary team of clinicians and scientists that reviews genomic testing results and provides guidance on treatment options based primarily on genomic data to the treating physician. The existence of a general multidisciplinary tumor board that addresses all aspects of patient care and treatment is not considered an exclusion criterion. A general multidisciplinary tumor board is defined as an interdisciplinary team of clinicians that primarily discusses all aspects of cancer care, including diagnostic aspects (pathology and radiology), therapeutic options (surgical, radiation and medical) as well as palliative and psychosocial support options.
10. PHYSICIAN PARTICIPANT INCLUSION
11. Physician participant must be a registering investigator of the Recruitment Center that is participating in the study. If the physician is a registering investigator at more than one Recruitment Center, he/she must choose one Recruitment Center to identify with and enroll patients from.
12. Physician participants must be board-eligible or board-certified in Medical Oncology or Gynecologic Oncology, or board-eligible or board-certified in Neurology with certification or eligible for certification in Neuro-oncology.
13. Physician participants must be willing to offer participation in the study to all eligible patients under their care for the duration of the study. A single physician may enroll multiple patients on the study.
14. Physician participants must be willing to complete all study questionnaires and, as part of the implementation objective, participate in interviews if invited.
15. Physician participants must complete all baseline questionnaires prior to registration.
16. Physician participants at a Recruitment Center randomized to the intervention arm must be willing to participate in the educationally enhanced Genomic Tumor Board (GTB) (EGTB).
17. PATIENT PARTICIPANT INCLUSION
18. Patient participants must have a solid tumor malignancy that is either recurrent, relapsed, refractory, metastatic, or newly diagnosed stage III or stage IV.
19. Patient participants must be under the care of a physician enrolled on the study.
20. Patient participants must not be going on hospice care at the time of registration.
21. Patient participants may have started anti-cancer treatment for the current diagnosis.
22. The treating physician anticipates that the patient will start a new anti-cancer treatment (either first or subsequent lines) within 6 months after registration. NOTE: The eligibility criterion above is meant to focus on physician intent. To provide a counter example, if a physician believes the patient’s treatment to be fixed and does not anticipate a change to treatment, even after examination of the GTT results, the patient is not eligible
23. Patient participants are allowed to be co-enrolled on other clinical trials including non-treatment studies and studies that include investigational drugs. Patients may be enrolled on genome-informed therapeutic trials, such as LungMAP, MATCH, or TAPUR.
24. Patient participant must have a genomic tumor test (GTT) ordered prior to registration with results pending. The genomic testing may be a commercially available panel (such as FoundationOne, Caris, or Tempus) or a non-commercial tumor panel performed at an academic medical center. * NOTE: Qualifying GTTs are defined as a genomic test conducted on the tumor tissue, tumor cells, or cell-free deoxyribonucleic acid (DNA) (cfDNA). They must be Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) tissue or liquid biopsy panels, including hotspot, whole gene, or DNA and ribonucleic acid (RNA) (including expression data) panels. Fluorescence-in-situ hybridization (FISH) and immunohistochemistry test results assessing cancer-relevant proteins (e.g. Her2/neu, ALK, MET) and immune parameters (e.g. PD-L1 tests) are also permissible if performed in the context of a larger panel that includes NGS or expression profiling. These tests can come from any commercial or academic laboratory within the United States (US) and they should be ordered with the intent to influence genome-informed treatment decision. Oncotype DX and other panels used for making treatment decisions based on a prognostic read-out (e.g. liquid biopsy minimal residual disease [MRD]) are not permitted. * NOTE: If multiple GTTs are sent simultaneously (i.e. liquid biopsy and tissue biopsy), none should be resulted prior to registration, however, if a PD-L1 immunohistochemistry (IHC) test was ordered as part of the GTT and the PD-L1 IHC result returns prior to the rest of the NGS panel, the patient is still eligible to be registered to the study.
25. Patient participants must be at least 18 years of age.
26. Patient participants must have a Zubrod performance status of 0-2.
27. Patient participants with tests assessing cancer-risk defining germline variants only (“germline test”) are not eligible.
28. Participants (patients and physicians) must sign and give written informed consent in accordance with institutional and federal guidelines. * NOTE: For this study, in the Oncology Patient Enrollment Network (OPEN) registration, physician participants will be listed as their own Treating Investigator. However, physician participants must not consent themselves or sign their own eligibility criteria forms * For patient participants with impaired decision-making capabilities, legally authorized representative may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations. Documentation of informed consent via remote consent is permissible.