An Open-label, Navigational Investigation of Profile-related Evidence Determining Individualized Cancer Therapy for Patients With Aggressive Malignancies and Poor Prognoses
Medical College of Wisconsin
Summary
This is a prospective, open-label navigational investigation designed to evaluate the feasibility of using molecular profile-based evidence to determine individualized cancer therapy for patients with aggressive malignancies. This is a non-randomized, histology-agnostic trial. Although there will be a case mix of histologies, the investigators now know that individual histologies are composed of a heterogeneous mix of molecular alterations. It is not clear whether one case mix is better or worse than another. Thus, the investigators are testing a strategy of molecular matching that may apply across different cancers.
Description
Eligible and consented patients, if not already performed, will have their tumor tissues/blood molecularly profiled. Patients will be stratified into Group 1 (treatment naïve, localized/unresectable/medically unfit for surgery), Group 2 (treatment naïve, metastatic), and Group 3 (prior treated). Based on multiomic profiling, matched therapy, if available, will be recommended by the Molecular Tumor Board. Patients who receive the recommended matched therapy are designated to Arm A. Otherwise, those that receive the unmatched therapy (i.e., treating physician's choice of therapy) or have no mole…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥18 years. 2. Patient with aggressive solid malignancy must meet at least one of the following: 1. Malignancy with ≥30% two-year cancer-associated mortality as estimated by the treating oncologist and one of the study investigators and/or, where appropriate, according to accepted data sets in the field (e.g., NCDB). Diseases include but are not limited to: ampullary carcinoma, appendiceal cancer, colorectal cancer (CRC), extrahepatic cholangiocarcinoma (EHCC), esophageal adenocarcinoma, gallbladder cancer (GBCA) gastric adenocarcinoma, head and neck cancer, hepa…
Interventions
- DrugTargeted agent
The Molecular Tumor Board (MTB) will suggest molecularly targeted "matched" treatment.
- DrugStandard of care agent
Subjects will receive treating physician's choice of traditional systemic therapy treatment for their malignancy, defined by National Comprehensive Cancer Network (NCCN) guidelines and/or tumor board recommendation(s).
Location
- Froedtert Hospital & the Medical College of WisconsinMilwaukee, Wisconsin