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.
Age ≥18 years.
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, hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (IHCC), melanoma, non-KIT gastrointestinal stromal tumor (GIST), non-small cell lung cancer (NSCLC), ovarian cancer, pancreatic ductal adenocarcinoma (PDAC), sarcoma (high-grade), small bowel adenocarcinoma (including duodenal), triple-negative breast cancer (TNBC), urothelial cancer
Refused standard therapies, OR
Cancer of unknown primary or a rare tumor (i.e., fewer than 4 cases per 100,000 per year) with no approved therapies.
Two oncologists disagree on prognosis or resectability.
Severe or uncontrolled medical disorder that would, in the investigator's opinion, confound study analyses of treatment response (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
Is pregnant or breastfeeding or any patient with childbearing potential not using adequate pregnancy prevention.
Whole brain radiation or stereotactic radiotherapy to CNS metastases within 14 days prior to start of study treatment.
Parallel
Targeted agent
DrugThe Molecular Tumor Board (MTB) will suggest molecularly targeted "matched" treatment.
Standard of care agent
DrugSubjects 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).
6
Treatment groupsSee each treatment group below.
Matched treatment
The number of subjects who receive matched treatment based on multiomic profiling analysis and MTB recommendations.
Actionable alterations
The number of subjects who have a genetic test result that can be matched with appropriate treatment that can target their specific mutation.
MTB recommended treatment
The number of subjects who receive the MTB recommended treatment.
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