Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform
NCT ID: NCT05520099
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
416 participants
OBSERVATIONAL
2023-06-26
2027-01-31
Brief Summary
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Detailed Description
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Elephas is developing a diagnostic platform using small 3D Live Tumor Fragments (LTFs) from participants for accurate prediction of drug response with a focus on CPIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to CPIs and other immunotherapies.
In this observational clinical basket trial, participants will be recruited and their actual clinical response (using RECIST 1.1) to CPIs across five solid tumors (lung, head/neck, bladder, kidney, and skin) will be compared to the platform's predictive Artificial Intelligence (AI) score that is based on RNA, clinical data, and 3D microscopy images. The sensitivity and specificity of the platform's score will be determined and compared to current diagnostic methods for CPIs like PDL1, MSI, and TMB.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
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.
Interventions
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Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
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
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Inclusion Criteria
2. Age ≥ 18 years at the time of consent.
3. 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
* 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.
4. Subjects must be clinically able, at investigator discretion, to undergo a biopsy procedure
5. 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
2. Subjects with a known auto-immune disease that would render them ineligible for immune-oncology treatment
3. Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy
4. Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial
18 Years
ALL
No
Sponsors
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Elephas
INDUSTRY
Responsible Party
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Principal Investigators
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Fred Hausheer, MD, FACP
Role: STUDY_DIRECTOR
Elephas
Locations
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CARTI Cancer Center
Little Rock, Arkansas, United States
Salinas Valley Memorial Healthcare System
Salinas, California, United States
AdventHealth Orlando
Orlando, Florida, United States
Memorial Health System
Pembroke Pines, Florida, United States
Cleveland Clinic Florida
Stuart, Florida, United States
University of South Florida (Tampa General Hospital)
Tampa, Florida, United States
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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David Hays
Role: primary
Irene Ball
Role: primary
Samantha Wright-Carless
Role: backup
Brittney Short
Role: primary
Danial Malik
Role: primary
Sheronda Brown
Role: primary
John Gaeddert
Role: primary
Markeela Lipscomb
Role: primary
Desma Jones
Role: backup
Sara John
Role: primary
References
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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.
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.
Ramasubramanian 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.
Other Identifiers
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ELEPHAS-02
Identifier Type: -
Identifier Source: org_study_id