Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform
ELEPHAS-02
1 other identifier
observational
416
1 country
12
Brief Summary
The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2022
CompletedFirst Posted
Study publicly available on registry
August 29, 2022
CompletedStudy Start
First participant enrolled
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
April 29, 2026
April 1, 2026
3.5 years
August 26, 2022
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine Ex-Vivo Prognostic Accuracy of Elephas Platform
The ex-vivo prognostic accuracy of the Elephas live tumor diagnostic platform will be determined using in-vivo RECIST 1.1 as the reference method.
3 years
Secondary Outcomes (1)
Establish AUC of ELEPHAS Score and Compare with FDA Approved Biomarkers
3 years
Study Arms (1)
Patients with suspected or diagnosed cancer types as listed in the description
Subjects suspected or diagnosed with recurrent, locally advanced or metastatic cancer: bladder (urothelial carcinoma), kidney (ccRCC). Subjects suspected or diagnosed with recurrent or metastatic cancer: Colon and Rectum (MSI-H/dMMR Colorectal Cancer), Head and Neck (Squamous Cell Carcinoma), liver (Hepatocellular Carcinoma), Lung (NSCLC), Skin (Cutaneous Melanoma), Uterus (endometrial cancer). Subjects suspected or diagnosed with one of the following cancer types eligible for pure ICI neoadjuvant therapy: Skin (Cutaneous Melanoma, Stage III) Subjects suspected or diagnosed with: Any solid tumor type that is eligible for pure ICI therapy in the neoadjuvant or advanced/metastatic setting; Any metastatic solid tumor with high TMB, MSI-High or dMMR and are being considered for treatment with ICI therapy; Any recurrent or metastatic patient with a solid tumor that the clinician plans to treat with ICI therapy.
Interventions
Subjects must be clinically able, at investigator discretion, to undergo additional core needle biopsy, forceps biopsy, or punch biopsy passes during their biopsy. These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to additional passes (e.g., liver or lymph nodes) per the clinician.
Eligibility Criteria
Adults aged 18 years or older, able to provide informed consent, and have a suspected or confirmed cancer diagnosis that meets requirements outlined in the eligibility criteria above.
You may qualify if:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- Subjects must meet one of the following criteria:
- Subjects suspected or diagnosed with recurrent, locally advanced or metastatic cancer:
- Bladder: Urothelial Carcinoma (UC)
- Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)
- Subjects suspected or diagnosed with recurrent or metastatic cancer:
- Colon and Rectum: Microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) Colorectal Cancer (CRC)
- Head and Neck: Squamous Cell Carcinoma (HNSCC), excluding nasopharyngeal and salivary gland cancers
- Liver: Hepatocellular Carcinoma
- Lung: Non-small cell lung cancer (NSCLC)
- Skin: Cutaneous Melanoma, excluding Uveal Melanoma
- Uterus: endometrial cancer
- Subjects suspected or diagnosed with one of the following cancer types eligible for pure ICI neoadjuvant therapy:
- o Skin: Cutaneous Melanoma, Stage III
- +6 more criteria
You may not qualify if:
- Subjects who are pregnant
- Subjects with a known auto-immune disease that would render them ineligible for immune-oncology treatment
- Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy
- Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elephaslead
Study Sites (12)
CARTI Cancer Center
Little Rock, Arkansas, 72205, United States
Salinas Valley Memorial Healthcare System
Salinas, California, 93901, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Memorial Health System
Pembroke Pines, Florida, 33026, United States
Cleveland Clinic Florida
Stuart, Florida, 34994, United States
University of South Florida (Tampa General Hospital)
Tampa, Florida, 33606, United States
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742, United States
John Theurer Cancer Center
Hackensack, New Jersey, 07601, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Related Publications (3)
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: 33937012BACKGROUNDCherukuri 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: 30032384BACKGROUNDRamasubramanian TS, Adstamongkonkul P, Scribano CM, Johnson C, Caenepeel S, Hrycyniak LCF, Vedder L, Dana N, Baltes C, Browning T, Chen YI, Dietz T, Flietner E, Kaplewski N, Kellner A, Korrer M, Liu C, Marhefke N, McDonnell P, Nasreen A, Pope V, Prasad A, Richardson J, Schneider S, Schultz M, Sood C, Sunil A, von Euw E, Wait E, Wargowski E, Advani P, Broome B, Bruckbauer A, Godwin A, Kokabi N, Martin R, Robaina M, Toia G, Routh J, Friedl A, Eliceiri K, Szulczewski M, Johnson S, Oliner J, Galon J, Capitini C, Mukhopadhyay D, Taube J, Braun D, Gierman HJ. A live tumor fragment platform to assess immunotherapy response in core needle biopsies while addressing challenges of tumor heterogeneity. bioRxiv [Preprint]. 2025 Jul 18:2025.07.18.663728. doi: 10.1101/2025.07.18.663728.
PMID: 40791544DERIVED
Biospecimen
Fresh tissue sample using core needle biopsy, forceps biopsy, or punch biopsy.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fred Hausheer, MD, FACP
Elephas
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2022
First Posted
August 29, 2022
Study Start
June 26, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share