Drug Screening Using Novel IMD in Renal Cell Carcinoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Oliver Jonas
Study ID
NCT05700461
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Implantable Microdevice (IMD) — COMBINATION_PRODUCT
    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.

Study Details

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)

Key Dates

Start date
Dec 1, 2024
Status verified
May 2026
Primary completion
Oct 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Implantable microdevice (IMD) + Biopsy + Standard of Care Treatment
    Participants with confirmed or suspected metastatic Renal Cell Carcinoma (RCC) and who are candidates for standard of care metastatectomy or debulking/consolidative nephrectomy will be selected for study participation and will undergo study procedures as outlined: * Placement of 1-6 microdevice(s) 72 +/- 24 hours prior to scheduled, standard of care surgery. The number of microdevices implanted into a tumor will be made on a case-by-case basis based on tumor and participant factors before and during the procedure. * At the time of standard of care surgery, surgical removal of microdevice(s) along with surrounding tumor tissue. * Monitoring for safety endpoints during inpatient stay and at a follow-up clinic visit.

Primary Outcome Measure

Safety of microdevice implantation [ Time Frame: Up to 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Wenxin Xu, MD
[email protected]
617-632-6534

Find similar trials in Boston, MA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Dana-Farber Cancer Institute· Boston, MA

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