Investigation of Profile-related Evidence Determining Individualized Cancer Therapy for Patients With Aggressive Malignancies and Poor Prognoses
Recruiting now · Phase 1/Phase 2
Conditions studied: Cancer
In brief
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.
Key facts
- Study ID
- NCT05674825
- Run by
- Medical College of Wisconsin
- People needed
- 400
- Starts
- 2022-12-21
- Expected to finish
- 2031-01-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years.
- Patient with aggressive solid malignancy must meet at least one of the following:
- 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.
- Patient with aggressive solid malignancy irrespective of two-year mortality who, in the opinion of the investigator, has no treatment option expected to yield significant clinical benefit.
- Patient must have at least one of the following for a diagnosis/disease status:
- Unresectable disease, as determined by a disease-appropriate multidisciplinary tumor board.
- Medically unfit for surgical resection but with an expected survival of > three months.
- Localized disease and are eligible for neoadjuvant treatment.
- Metastatic disease.
- Disease where no conventional therapy leads to a survival benefit > six months in the respective cohort and line of therapy for which the patient is otherwise eligible.
- Patient is either:
- Treatment naïve for their newly diagnosed malignancy (for enrollment to Groups 1 or 2), or
- Status post one or more systemic therapy regimens, whether matched or unmatched (for enrollment to Group 3). Note: There are no limitations on the number of prior local therapies.
- Patient must have measurable disease for malignancy: defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, positron emission tomography (PET) -CT, MRI, or calipers by clinical exam.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- New York Heart Association (NYHA) Functional Classification I-II
- Adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1.0 x 109/L
- Platelet count ≥ 75 x 109/L
- Total bilirubin ≤ 2.0 x institution's upper limit of normal (ULN)
- Patients without underlying liver disease
- alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 x institutional ULN
- Serum creatinine ≤ 2.0 x institution's ULN or 24-hour creatinine clearance ≥ 30 ml/min
You may not qualify if…
- A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- 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.
Where it is running
- Froedtert Hospital & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
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