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RecruitingObservational

Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies

NCT ID: NCT07327489Sponsor: ElephasLast updated: 2026-01-08

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.

Arms & interventions

  • ProcedureBiopsy

    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.

Outcome measures

Primary

  • 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.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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).

Study locations (8)

Mercy Hospital - FTS

Fort Smith, Arkansas, 72903

Recruiting
Billy Cater · Contact
Aswanth Reddy, MD · Principal Investigator

Frederick Health Hospital

Frederick, Maryland, 21702

Recruiting
Ingrid Halvorson · Contact
Heather Chalfin, MD · Principal Investigator

Mercy Hospital - SPG

Springfield, Missouri, 65804

Recruiting
Hanna Dulier, RN. BSN · Contact
Mohan Tummala, MD · Principal Investigator

Mercy Hospital - South

St Louis, Missouri, 63128

Recruiting
Danielle Werle, RN, BSN · Contact
Yifan Tu · Principal Investigator

Mercy Hospital -STL

St Louis, Missouri, 63141

Recruiting
Nancy Umbeck · Contact
Bethany Sleckman · Principal Investigator

Mercy Hospital - OKC

Oklahoma City, Oklahoma, 73120

Recruiting
Trisha Stubhar · Contact
Carla Kurkjian · Principal Investigator

JPS Health Network

Forth Worth, Texas, 76104

Recruiting
April Bell, MS, CCRC, ACRP-PM · Contact
Paras Patel · Principal Investigator

Baylor Scott and White Biorepository

Temple, Texas, 76508

Not Yet Recruiting
Mathew Bower, MD · Principal Investigator

References

  • 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.(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.(PubMed)