Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies

NCT ID: NCT07327489

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-14

Study Completion Date

2038-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Biopsy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Elephas

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mercy Hospital - FTS

Fort Smith, Arkansas, United States

Site Status RECRUITING

Frederick Health Hospital

Frederick, Maryland, United States

Site Status RECRUITING

Mercy Hospital - SPG

Springfield, Missouri, United States

Site Status RECRUITING

Mercy Hospital - South

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital -STL

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital - OKC

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

JPS Health Network

Forth Worth, Texas, United States

Site Status RECRUITING

Baylor Scott and White Biorepository

Temple, Texas, United States

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Billy Cater

Role: primary

479-314-5089

Ingrid Halvorson

Role: primary

301-662-8477

Hanna Dulier, RN. BSN

Role: primary

4178203891

Danielle Werle, RN, BSN

Role: primary

3145256042

Alesia Bell

Role: primary

(314) 251-4400

Nancy Umbeck

Role: backup

Trisha Stubhar

Role: primary

405-751-4343 ext. 4057523401

April Bell, MS, CCRC, ACRP-PM

Role: primary

817-702-8254

Vanessa Hoelscher

Role: primary

254-724-6759

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33937012 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30032384 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ELEPHAS-05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pan-tumor MRD Study
NCT06605404 RECRUITING