Recruiting
Phase 1

Implantable Microdevice

Sponsor:

Oliver Jonas

Code:

NCT05700461

Conditions

Renal Cell Carcinoma

Metastatic Renal Cell Carcinoma

Kidney Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Implantable Microdevice (IMD)

Study Details

Brief 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)

Conditions

Renal Cell Carcinoma

Metastatic Renal Cell Carcinoma

Kidney Cancer

Study ID

NCT05700461

Start date

Dec 1, 2024

Status verified date

May, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have the ability to understand and the willingness to sign a written informed consent document.
  • Participants must have confirmed or suspected localized or metastatic renal cell carcinoma, and must be planned for either nephrectomy or metastatectomy as part of their clinical care. The lesion planned for excision must be at least 1cm in size.
  • Participants must be 18 years of age or older.
  • Participants must be evaluated by a medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease.
  • Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures.
  • Participants will undergo laboratory testing within 30 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood draw). Patients must have absolute neutrophil count ≥1,000/mcL, platelets ≥50,000/mcL, INR < 1.5 and PTT <1.5x control.
  • Participants must have undergone CT or MRI that assesses the extent of disease and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care.
  • The participant's case must be reviewed by representatives of interventional radiology and the appropriate surgical subspecialty to assess the following factors:
  • Patient is clinically stable to undergo microdevice implantation and surgical procedures
  • Patient has sufficient volume of disease to allow implantation of the microdevice
  • Patient has a lesion for which the microdevice is a) amenable to percutaneous placement, and b) amenable to removal at the time of surgery
  • Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.

Exclusion Criteria

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
  • Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures (detailed below).

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Implantable 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.

Primary outcome measure

  • Safety of microdevice implantation [ Time Frame: Up to 30 days ]
  • Number of Patients with Feasible Microdevice Procedure [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Wenxin Xu, MD

617-632-6534Wenxin_Xu1@dfci.harvard.edu

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Wenxin Xu, MD

617-632-6534Wenxin_Xu1@dfci.harvard.edu

More Information

Sponsor

Oliver Jonas

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma
  • Kidney Cancer
  • Suspected Renal Cell Carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Oliver Jonas on 2026-05-18.