Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)

Prior treatment

• Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy

Other illness

• Subjects with a known auto-immune disease that would render them ineligible for immune-oncology treatment

Other

• Subjects who are pregnant
• Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial

• 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.