RecruitingPhase 1NCT05700461

Drug Screening Using Novel IMD in Renal Cell Carcinoma

Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Renal Cell Carcinoma


Sponsor

Oliver Jonas

Enrollment

20 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This research is being done to study the safety and feasibility of implanting and retrieving a microdevice that releases microdoses of 19 specific drugs or drug combinations as a possible tool to evaluate the effectiveness of several cancer drugs against metastatic renal cell carcinoma (RCC). The name of the intervention(s) involved in this study are: * Implantable Microdevice (IMD) * Surgery (excision of tumor) * Drugs used in this study will only include drugs already used as standard of care for the treatment of metastatic renal cell carcinoma (RCC)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a specialized laboratory device to test cancer drugs directly on tumor tissue removed from kidney cancer patients — aiming to identify which drugs work best for each individual before treating them, a step toward personalized cancer care. **You may be eligible if...** - You are 18 or older with confirmed or suspected metastatic renal cell carcinoma (kidney cancer that has spread) - You are already scheduled for surgery to remove your kidney or a metastatic lesion as part of your standard care - The lesion being removed is at least 1 cm in size - You are medically stable enough for both surgery and biopsy procedures **You may NOT be eligible if...** - You have blood clotting disorders or are on anticoagulants that cannot be safely managed - Your tumor tissue cannot be safely biopsied or removed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTImplantable Microdevice (IMD)

Small, implantable device with 20 microreservoirs for drug and drug combinations, via needle, percutaneously, and guided by interventional radiologic techniques. Drugs include all or a subset of the following: Cabozantinib, Pazopanib, Lenvatinib, Axitinib, Ipilimumab, Nivolumab, Pembrolizumab, Carboplatin, Paclitaxel, Abemaciclib, Gemcitabine, Everolimus, Belzutifan, Cabozantinib + nivolumab, Cabozantinib + belzutifan, Ipilimumab + nivolumab, Lenvatinib + pembrolizumab, Lenvatinib + everolimus, Abemaciclib + belzutifan, and Tivozanib. Other medications on the microdevice may be substituted pending updates in clinical and scientific data.


Locations(1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

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NCT05700461


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