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

Elephas2,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Cancer Immunotherapy Advanced Solid Tumors Cancer Bladder Cancer TNBC, Triple Negative Breast Cancer Colorectal Cancer

Interventions

BiopsyPROCEDURE

Subjects must be clinically able, at investigator discretion, to undergo additional biopsy passes during their biopsy. Biopsy specimen(s) will be obtained during a standard of care (SOC) procedure. If a subject receives a subsequent SOC biopsy for clinical diagnosis purposes, additional sample(s) may be collected and sent to the Sponsor.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (8)

Mercy Hospital - FTS

Fort Smith, Arkansas, United States

RECRUITING

Frederick Health Hospital

Frederick, Maryland, United States

RECRUITING

Mercy Hospital - SPG

Springfield, Missouri, United States

RECRUITING

Mercy Hospital - South

St Louis, Missouri, United States

RECRUITING

Mercy Hospital -STL

St Louis, Missouri, United States

RECRUITING

Mercy Hospital - OKC

Oklahoma City, Oklahoma, United States

RECRUITING

JPS Health Network

Forth Worth, Texas, United States

RECRUITING

Baylor Scott and White Biorepository

Temple, Texas, United States

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors & Researching Mechanisms of Tumor Cutting and Imaging

Collect human tumor specimens to research mechanisms of tumor cutting, imaging, and ex-vivo immunotherapy treatment response, while maintaining cell stability in a live tumor microenvironment.

Time frame: Study duration is approximately 36 months from enrollment to end of study.