Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies

NCT07327489 | Recruiting

• 1 other identifier: ELEPHAS-05
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Cancer; Immunotherapy; Advanced Solid Tumors Cancer; Bladder Cancer; TNBC, Triple Negative Breast Cancer; Colorectal Cancer; Kidney Cancer; DMMR Colorectal Cancer; MSI-H Colorectal Cancer; Endometrial Cancer; Head and Neck Cancer; Liver Cancer; NSCLC (Non-small-cell Lung Cancer); Skin Cancer; Melanoma (Skin Cancer)

Keywords

Immunotherapy; Live Tumor Biopsy; Elephas; Cancer; Imaging; Tumor Cutting; Treatment Response; Core Needle Biopsy; Forceps Biopsy; Punch Biopsy

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

Study Population

Adults aged 18 years or older, who are able and willing to provide written informed consent, have a suspected or confirmed cancer diagnosis and will be undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up.

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

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 Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 years or older, who are able and willing to provide written informed consent, have a suspected or confirmed cancer diagnosis and will be undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up.

You may qualify if:

• Able and willing to provide informed consent for participation
• Age ≥18 years at time of consent.
• Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.
• 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.

You may not qualify if:

• 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.
• Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.
• Pregnant person(s).

Sponsors & Collaborators

• Elephas: lead

Study Sites (8)

Mercy Hospital - FTS

Fort Smith, Arkansas, 72903, United States

RECRUITING

Frederick Health Hospital

Frederick, Maryland, 21702, United States

RECRUITING

Mercy Hospital - SPG

Springfield, Missouri, 65804, United States

RECRUITING

Mercy Hospital - South

St Louis, Missouri, 63128, United States

RECRUITING

Mercy Hospital -STL

St Louis, Missouri, 63141, United States

RECRUITING

Mercy Hospital - OKC

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

JPS Health Network

Forth Worth, Texas, 76104, United States

RECRUITING

Baylor Scott and White Biorepository

Temple, Texas, 76508, United States

NOT YET RECRUITING

Related Publications (2)

• Chen S, Zhang Z, Zheng X, Tao H, Zhang S, Ma J, Liu Z, Wang J, Qian Y, Cui P, Huang D, Huang Z, Wu Z, Hu Y. Response Efficacy of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Apr 16;11:562315. doi: 10.3389/fonc.2021.562315. eCollection 2021.

  PMID: 33937012 BACKGROUND

• Cherukuri AR, Lubner MG, Zea R, Hinshaw JL, Lubner SJ, Matkowskyj KA, Foltz ML, Pickhardt PJ. Tissue sampling in the era of precision medicine: comparison of percutaneous biopsies performed for clinical trials or tumor genomics versus routine clinical care. Abdom Radiol (NY). 2019 Jun;44(6):2074-2080. doi: 10.1007/s00261-018-1702-1.

  PMID: 30032384 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Remaining specimens or specimen derivatives (e.g. H\&E slides) may be banked indefinitely.

MeSH Terms

Conditions

Neoplasms; Urinary Bladder Neoplasms; Triple Negative Breast Neoplasms; Colorectal Neoplasms; Endometrial Neoplasms; Head and Neck Neoplasms; Kidney Neoplasms; Liver Neoplasms; Carcinoma, Non-Small-Cell Lung; Skin Neoplasms; Melanoma

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Kidney Diseases; Liver Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 8, 2026
• Study Start: April 14, 2025
• Primary Completion (Estimated): April 1, 2035
• Study Completion (Estimated): April 1, 2038
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)