Observational Basket Trial to Collect T… | Clinical Trial

Key information

Conditions

Immunotherapy Adenocarcinoma Bladder Cancer Bronchial Neoplasms Cancer Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Clear Cell Renal Cell Cancer (ccRCC) Colonic Diseases Colorectal Cancer Colorectal Neoplasms Cutaneous Melanoma Digestive System Diseases Digestive System Neoplasms Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Cancer (H&N) Head and Neck Neoplasms Hepatocellular Carcinoma (HCC) Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer (NSCLC) Lung Diseases Lung Neoplasms MSI-H Colorectal Cancer Male Urogenital Diseases Melanoma NSCLC (Non-small Cell Lung Cancer) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Solid Tumor Cancer Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma Bladder Uterine Diseases Uterine Neoplasms dMMR Colorectal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CARTI Cancer Center, Little Rock, Arkansas, United States

About this study

Cancer is a leading cause of death and despite many new drugs, a major diagnostic challenge remains knowing which drug will work best for a patient. A new class of drugs called checkpoint inhibitors (CPIs) have revolutionized cancer treatment. However, current diagnostic methods (e.g. PDL1, MSI and TMB) do not accurately predict which patients will respond.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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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

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.
Subjects must be clinically able, at investigator discretion, to undergo a biopsy procedure
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

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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

Treatment and study plan

Core Needle Biopsy, Forceps Biopsy, Punch Biopsy

Procedure

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.

Primary outcomes

Determine Ex-Vivo Prognostic Accuracy of Elephas Platform

Time frame: 3 years

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.

Secondary outcomes

Establish AUC of ELEPHAS Score and Compare with FDA Approved Biomarkers

Time frame: 3 years

The AUC of ELEPHAS Score will be established with a clinically meaningful confidence interval and compared to the AUCs of established FDA approved biomarkers for predicting clinical response to ICIs.

Sponsors and collaborators

Lead sponsor

Elephas

Industry

Registry information

Acronym: ELEPHAS-02

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Aug 29, 2022
Registry last updated: Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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