NCT07327489Recruiting

Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)

Elephas

Start Date

4/14/2025

Completion Date

4/1/2038

Summary

This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.

Detailed Description

Elephas is researching mechanisms of cutting, sorting and imaging tumors that leave the 3D tumor microenvironment (TME), including its immune cells, intact. This allows qualitative and semi-quantitative identification and characterization of the ex vivo response to exposure of potential immunotherapy. The ex vivo response data will then be compared to the clinical real world response data to inform development efforts. This study will collect tumor specimens from patients with suspected or confirmed cancer. These specimens, along with clinical data and genomic data obtained as part of a patient's standard of care, will be used to perform this research.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Able and willing to provide informed consent for participation 2. Age ≥18 years at time of consent. 3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy. 4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment. Exclusion Criteria: 1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment. 2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients. 3. Pregnant person(s).

Interventions

PROCEDURE

Biopsy

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Conditions

CancerImmunotherapyAdvanced Solid Tumors CancerBladder CancerTNBC, Triple Negative Breast CancerColorectal CancerDMMR Colorectal CancerMSI-H Colorectal CancerEndometrial CancerHead and Neck CancerKidney CancerLiver CancerNSCLC (Non-small-cell Lung Cancer)Skin CancerMelanoma (Skin Cancer)

Locations

Mercy Hospital - FTS

Fort Smith, Arkansas 72903

United States

Frederick Health Hospital

Frederick, Maryland 21702

United States

Mercy Hospital - SPG

Springfield, Missouri 65804

United States

Mercy Hospital - South

St Louis, Missouri 63128

United States

Mercy Hospital -STL

St Louis, Missouri 63141

United States

Mercy Hospital - OKC

Oklahoma City, Oklahoma 73120

United States

JPS Health Network

Forth Worth, Texas 76104

United States

Baylor Scott and White Biorepository

Temple, Texas 76508

United States