Active, not recruiting
Observational
Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)
Condition(s) studied
ImmunotherapyCancerBladder CancerUrothelial Carcinoma BladderKidney CancerClear Cell Renal Cell Cancer (ccRCC)Colorectal CancerMSI-H Colorectal CancerDMMR Colorectal CancerHead and Neck Cancer (H&N)Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)Liver CancerHepatocellular Carcinoma (HCC)Lung Cancer (NSCLC)NSCLC (Non-small Cell Lung Cancer)Skin CancerCutaneous MelanomaEndometrial CancerSolid Tumor Cancer
Investigational drug(s) / intervention(s)
Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
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.
Study 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
Eligibility
Inclusion Criteria --
1. 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.
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 --
1. Subjects who are pregnant
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
Primary outcome measure(s)
- Determine Ex-Vivo Prognostic Accuracy of Elephas Platform — 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.
Trial sites (12)
| Facility | City | Region | Status |
| CARTI Cancer Center |
Little Rock |
Arkansas |
|
| Salinas Valley Memorial Healthcare System |
Salinas |
California |
|
| AdventHealth Orlando |
Orlando |
Florida |
|
| Memorial Health System |
Pembroke Pines |
Florida |
|
| Cleveland Clinic Florida |
Stuart |
Florida |
|
| University of South Florida (Tampa General Hospital) |
Tampa |
Florida |
|
| University of Louisville James Graham Brown Cancer Center |
Louisville |
Kentucky |
|
| Meritus Center for Clinical Research |
Hagerstown |
Maryland |
|
| John Theurer Cancer Center |
Hackensack |
New Jersey |
|
| Roswell Park Comprehensive Cancer Center |
Buffalo |
New York |
|
| University of North Carolina at Chapel Hill |
Chapel Hill |
North Carolina |
|
| University of Wisconsin |
Madison |
Wisconsin |
|
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