Clinical trial NCT06264479: Prospective Evaluation of AI R&D Tool for Patient Stratification: a Trial for Renal Immuno-oncology Model Experimental Evaluation 2
Official title: Prospective Evaluation of AI R&D Tool for Patient Stratification: a Trial for Renal Immuno-oncology Model Experimental Evaluation 2
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Kidney Cancer
Renal Cell Cancer Metastatic
Keywords: computer vision
cell culture
microtumor
functional testing
predictive biomarker
immuno-oncology
Lead sponsor: Ourotech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Royal Free Hospital NHS Foundation Trust
name: Cambridge University Hospitals NHS Trust
name: East & North Herts NHS Trust
name: Imperial College Healthcare NHS Trust
First posted: 2024-02-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced or metastatic kidney cancer, due to start a new line of therapy

Brief summary: Pear Bio has developed a predictive biomarker technology that combines 3D cell culture, microscopy and computer vision to measure the response of an individual patient's tumor sample to different systemic therapy regimens that are tested simultaneously ex vivo.

This study will recruit patients with advanced or metastatic kidney cancer who are due to start a clinically-indicated new line of therapy.

The oncologist will be blinded to the response on the Pear Bio test (the test will be run in parallel with the patient's treatment). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's test results against patient outcomes (objective response, progression-free survival, depth and duration of response, overall survival).

Detailed description: This is a multicenter, international, observational pilot study that aims to determine the accuracy of a new assay, the Pear Bio test, in predicting response rate (ORR) in patients receiving standard of care systemic therapies for kidney cancer. Patients will undergo an additional, mandatory core needle biopsy of a lesion before commencing their next line of therapy. 40mL of blood will also be collected from each patient.

The biopsy sample will be run on the Pear Bio test while the patient receives their standard of care treatment. As such, for this study, the result from the Pear Bio test will not be used to inform the choice of treatment and the treating oncologist will be blinded to the test results.

The investigators will measure objective response rate (ORR) and other outcome metrics (PFS, DoR, OS, etc.). The Pear Bio test results will be compared to the actual patient outcomes to determine the test's sensitivity, specificity, positive predictive value and negative predictive value.

Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate correlation accuracy (sensitivity & specificity)
timeFrame: 6 months
Secondary outcomes:
measure: Complete Response rate correlation accuracy (sensitivity & specificity)
timeFrame: 2 years
measure: Deep Response rate correlation accuracy (sensitivity & specificity)
timeFrame: 2 years
measure: Durable Response rate correlation accuracy (sensitivity & specificity)
timeFrame: 2 years
measure: PFS prediction accuracy
timeFrame: 2 years
Other outcomes:
measure: Culture success rate
timeFrame: 4 days
measure: Hazard ratio by biomarker group
timeFrame: 2 years
measure: OS prediction accuracy
timeFrame: 2 years
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
city: London
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Royal Free NHS Foundation Trust
Study officials:
affiliation: Royal Free Hospital NHS Foundation Trust
name: Ekaterini Boleti
role: PRINCIPAL_INVESTIGATOR
References: