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

Kidney Cancer Clinical Trial

— PEAR-TREE2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06264479
• Other study ID #: PEAR-TREE2
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: March 31, 2029

Study information

• Verified date: April 2024
• Source: Ourotech, Inc.
• Contact: Duleek Ranatunga
• Phone: +44 7716558079
• Email: duleek[@]pearbio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 31, 2029
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Renal Cell Cancer Metastatic

Intervention

Procedure:
• Biopsy
Patients undergo a biopsy from a lesion, and give 40ml of blood

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge	Cambridgeshire
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Mount Vernon Cancer Centre	London
United Kingdom	Royal Free NHS Foundation Trust	London

Sponsors (5)

Lead Sponsor	Collaborator
Ourotech, Inc.	Cambridge University Hospitals NHS Trust, East & North Herts NHS Trust, Imperial College Healthcare NHS Trust, Royal Free Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Culture success rate	The percentage of patient samples successfully arriving at central lab with >100k live cells isolated and maintaining 70% cell viability after 4 days in culture with no treatment	4 days
Other	Hazard ratio by biomarker group	The hazard ratio for PFS and OS between Pear-assay biomarker-high and biomarker-low groups	2 years
Other	OS prediction accuracy	The performance of Pear image-based biomarkers are established against patients overall survival.	2 years
Primary	Objective Response Rate correlation accuracy (sensitivity & specificity)	The sensitivity, specificity PPV and NPV of Pear image-based biomarkers are established against patient ORR (evaluated on imaging).	6 months
Secondary	Complete Response rate correlation accuracy (sensitivity & specificity)	The sensitivity, specificity PPV and NPV of Pear image-based biomarkers are established against patients achieving a complete response (evaluated by imaging).	2 years
Secondary	Deep Response rate correlation accuracy (sensitivity & specificity)	The sensitivity, specificity PPV and NPV of Pear image-based biomarkers are established against patients achieving a deep response (evaluated by imaging).	2 years
Secondary	Durable Response rate correlation accuracy (sensitivity & specificity)	The sensitivity, specificity PPV and NPV of Pear image-based biomarkers are established against patients achieving a durable response at 6, 12 and 24 months (evaluated by imaging).	2 years
Secondary	PFS prediction accuracy	The performance of Pear image-based biomarkers are established against patients progression-free survival at 6, 12 and 24 months (evaluated by imaging).	2 years