Neoplasms

Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Neoplasm Metastasis

Aggression

Subjects will be grouped into one of three study groups (Groups 1, 2, or 3) based on their disease status and history of prior cancer therapy. Group 1 subjects will comprise treatment naïve subjects with localized disease and (i) are eligible for neoadjuvant treatment, (ii) have unresectable disease, or (iii) are medically unfit for surgical resection.

Subjects will be grouped into one of three study groups (Groups 1, 2, or 3) based on their disease status and history of prior cancer therapy. Group 2 will comprise treatment naïve subjects with metastatic disease.

Subjects will be grouped into one of three study groups (Groups 1, 2, or 3) based on their disease status and history of prior cancer therapy. Group 3 will comprise subjects with metastatic or unresectable disease who have received at least one prior systemic therapy, whether matched or unmatched.

The Molecular Tumor Board (MTB) will suggest molecularly targeted "matched" treatment.

Targeted 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).

Standard of care agent

Medical College of Wisconsin Cancer Center Clinical Trials Office

Ben George, MD

Razelle Kurzrock, MD

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.

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 molecular alterations are designated to Arm B. The study feasibility will be measured by the ability to enroll patients, the acceptable turnaround time and the actionable information obtained from multiomic profiling, and the viability of identifying and delivering the matched therapy.

Investigation of Profile-related Evidence Determining Individualized Cancer Therapy for Patients With Aggressive Malignancies and Poor Prognoses

An Open-label, Navigational Investigation of Profile-related Evidence Determining Individualized Cancer Therapy for Patients With Aggressive Malignancies and Poor Prognoses

The number of subjects who receive matched treatment based on multiomic profiling analysis and MTB recommendations.

The number of subjects who have a genetic test result that can be matched with appropriate treatment that can target their specific mutation.

The number of subjects who receive the MTB recommended treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Investigation of Profile-related Evidence Determining Individualized Cancer Therapy for Patients With Aggressive Malignancies and Poor Prognoses	NCT05674825	Cancer	Targeted agent Standard of car...	18 Years -	Medical College of Wisconsin
Investigation of Profile-related Evidence Determining Individualized Cancer Therapy for Patients With Aggressive Malignancies and Poor Prognoses	NCT05674825	Cancer	Targeted agent Standard of car...	18 Years -	Medical College of Wisconsin

Spots Global Cancer Trial Database for unresectable disease