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Recruiting Observational

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

NCT07327489 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Observational
Started
2025-04-14
Last updated
2026-06-29

Condition(s) studied

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)

Investigational drug(s) / intervention(s)

Biopsy

Biopsy: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors & Researching Mechanisms of Tumor Cutting and Imaging — Study duration is approximately 36 months from enrollment to end of study.
    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.

Trial sites (8)

FacilityCityRegionStatus
Mercy Hospital - FTS Fort Smith Arkansas Recruiting
Frederick Health Hospital Frederick Maryland Recruiting
Mercy Hospital - SPG Springfield Missouri Recruiting
Mercy Hospital - South St Louis Missouri Recruiting
Mercy Hospital -STL St Louis Missouri Recruiting
Mercy Hospital - OKC Oklahoma City Oklahoma Recruiting
JPS Health Network Forth Worth Texas Recruiting
Baylor Scott and White Biorepository Temple Texas Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07327489 on ClinicalTrials.gov ↗ ← All trials in the USA