The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method
Cancer is a leading cause of death and despite many new drugs, a major diagnostic challenge remains knowing which drug will work best for a patient. A new class of drugs called checkpoint inhibitors (CPIs) have revolutionized cancer treatment. However, current diagnostic methods (e.g. PDL1, MSI and TMB) do not accurately predict which patients will respond. Elephas is developing a diagnostic platform using small 3D Live Tumor Fragments (LTFs) from participants for accurate prediction of drug response with a focus on CPIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to CPIs and other immunotherapies. In this observational clinical basket trial, participants will be recruited and their actual clinical response (using RECIST 1.1) to CPIs across five solid tumors (lung, head/neck, bladder, kidney, and skin) will be compared to the platform's predictive Artificial Intelligence (AI) score that is based on RNA, clinical data, and 3D microscopy images. The sensitivity and specificity of the platform's score will be determined and compared to current diagnostic methods for CPIs like PDL1, MSI, and TMB.
Study Type
OBSERVATIONAL
Enrollment
416
Subjects must be clinically able, at investigator discretion, to undergo additional core needle biopsy, forceps biopsy, or punch biopsy passes during their biopsy. These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to additional passes (e.g., liver or lymph nodes) per the clinician.
CARTI Cancer Center
Little Rock, Arkansas, United States
RECRUITINGSalinas Valley Memorial Healthcare System
Salinas, California, United States
TERMINATEDAdventHealth Orlando
Orlando, Florida, United States
TERMINATEDMemorial Health System
Pembroke Pines, Florida, United States
SUSPENDEDCleveland Clinic Florida
Stuart, Florida, United States
RECRUITINGUniversity of South Florida (Tampa General Hospital)
Tampa, Florida, United States
RECRUITINGUniversity of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, United States
RECRUITINGMeritus Center for Clinical Research
Hagerstown, Maryland, United States
RECRUITINGJohn Theurer Cancer Center
Hackensack, New Jersey, United States
TERMINATEDRoswell Park Comprehensive Cancer Center
Buffalo, New York, United States
RECRUITING...and 2 more locations
Determine Ex-Vivo Prognostic Accuracy of Elephas Platform
The ex-vivo prognostic accuracy of the Elephas live tumor diagnostic platform will be determined using in-vivo RECIST 1.1 as the reference method.
Time frame: 3 years
Establish AUC of ELEPHAS Score and Compare with FDA Approved Biomarkers
The AUC of ELEPHAS Score will be established with a clinically meaningful confidence interval and compared to the AUCs of established FDA approved biomarkers for predicting clinical response to ICIs.
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.