Prospective Evaluation of AI R&D Tool for Patient Stratification: a Trial for Renal Immuno-oncology Model Experimental Evaluation 2

Inclusion:

1. Able to give written informed consent prior to admission to this study.

2. Female or male aged ≥18 years.

3. Evidence of advanced RCC with intention to receive systemic therapy, defined as:

- Clinical suspicion of advanced RCC with intention to undergo a
clinically-mandated biopsy and subsequent systemic therapy OR

- Histological evidence of advanced RCC with intention to undergo subsequent
systemic therapy and willing to undergo additional research biopsy

4. At least one lesion evaluable under RECIST 1.1 criteria

5. Willing to donate at least two additional core biopsy samples prior to starting
subsequent systemic therapy.

6. Willing to undergo venous sampling for 40mL of blood

Exclusion:

1. Early stage kidney cancer

2. Patients who do not have kidney cancer

3. Patients with RCC that do not intend to receive systemic therapy

4. Patients who have already commenced systemic therapy with no plans of changing the
systemic therapy after the collection of the core needle biopsy.

5. Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that, in the investigator's opinion, gives reasonable suspicion
of a disease or condition that may affect the interpretation of the results, render
the patient at high risk from treatment complications or interferes with obtaining
informed consent.

6. Previous diagnosis of other cancer. Previously treated cancer may be acceptable in
some circumstances (e.g. surgery for an unrelated cancer > 5 years ago) after
discussion with the Sponsor.

7. No lesions are amenable to biopsy