Bladder Cancer Clinical Trials

• 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.