Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform

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

Conditions21

Locations12 sites

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