Renal Cell CarcinomaPhase 1NCT05700461
Drug Screening Using Novel IMD in Renal Cell Carcinoma
A Phase 1 study testing Implantable Microdevice (IMD) in people with Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by Oliver Jonas at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Kidney Cancer
- What is being tested?
- Implantable Microdevice (IMD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 31 Aug 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Wenxin Xu, MD, 617-632-6534, Wenxin_Xu1@dfci.harvard.edu
About this study
Official title: Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Renal Cell Carcinoma
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)
Read the detailed description
This Pilot 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 drugs participants receive will include medications currently used as standard-of-care treatment for metastatic RCC as well as medications currently approved in other cancer types that are under investigation for treatment of RCC.
- This study involves planting one or more microdevices, each small enough to fit inside the tip of a needle, into a tumor. The microdevices will release microdoses of cancer drugs via passive diffusion. The drugs will only penetrate the local tumor tissues.
- After approximately 3 days, the microdevices and small regions of surrounding tissues will be removed and analyzed.
The research study procedures include screening for eligibility, study imaging and evaluations, blood collections, tumor biopsies, and follow up visits.
The U.S. Food and Drug Administration (FDA) has not approved the microdevice as a treatment for any disease.
The drugs being used have been FDA-approved for the treatment of cancers.
Participation in this research study is expected to last up to 4 months.
It is expected that about 20 people (10 each in Cohort 1 and Cohor 2) will take part in this research study.
- Being tested
- Implantable Microdevice (IMD)
- Keywords
- Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Kidney Cancer, Suspected Renal Cell Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Implantable microdevice (IMD) + Biopsy + Standard of Care Treatment | Experimental | 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. Receives: Combination Product: Implantable Microdevice (IMD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of microdevice implantation
- Any grade 3-5 adverse events likely or definitely attributable to device placement or retrieval
- Any death attributable to the study procedures and not attributable to the underlying malignancy or external causes
- Any device resulting in major adverse events as defined in the protocol
Measured: Up to 30 days
Number of Patients with Feasible Microdevice Procedure
For Cohort 1, this is defined as technical success of microdevice placement and successful retrieval of the microdevice from the surgery specimen with sufficient amount and quality of tissue for histopathology analysis and interpretation of at least 50% of the microdevice reservoirs. For Cohort 2, feasibility is defined as successful microdevice placement and the successful retrieval of at least one microdevice per patient with sufficient amount and quality of tissue for histopathology analysis and interpretation of at least 50% of the reservoirs on that microdevice.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Dec 2024
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oliver Jonas
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Sponsor-investigator, Oliver Jonas, Brigham and Women's Hospital
- Investigators
- Wenxin Xu, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700461
- Sponsor's protocol ID
- 22-492
- Status last verified
- May 2026
- First submitted
- 17 Jan 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05700461
- Acronym / sponsor ID
- 22-492
- Keywords
- Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Kidney Cancer, Suspected Renal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oliver JonasUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
This Pilot 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 drugs participants receive will include medications currently used as standard-of-care treatment for metastatic RCC as well as medications currently approved in other cancer types that are under investigation for treatment of RCC.
- This study involves planting one or more microdevices, each small enough to fit inside the tip of a needle, into a tumor. The microdevices will release microdoses of cancer drugs via passive diffusion. The drugs will only penetrate the local tumor tissues.
- After approximately 3 days, the microdevices and small regions of surrounding tissues will be removed and analyzed.
The research study procedures include screening for eligibility, study imaging and evaluations, blood collections, tumor biopsies, and follow up visits.
The U.S. Food and Drug Administration (FDA) has not approved the microdevice as a treatment for any disease.
The drugs being used have been FDA-approved for the treatment of cancers.
Participation in this research study is expected to last up to 4 months.
It is expected that about 20 people (10 each in Cohort 1 and Cohor 2) will take part in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantable microdevice (IMD) + Biopsy + Standard of Care Treatment | Experimental | Combination Product: Implantable Microdevice (IMD)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Implantable microdevice (IMD) + Biopsy + Standard of Care Treatment |
Primary outcome
Safety of microdevice implantation
Time frame: Up to 30 days
* Any grade 3-5 adverse events likely or definitely attributable to device placement or retrieval * Any death attributable to the study procedures and not attributable to the underlying malignancy or external causes * Any device resulting in major adverse events as defined in the protocol
Number of Patients with Feasible Microdevice Procedure
Time frame: 72 hours
For Cohort 1, this is defined as technical success of microdevice placement and successful retrieval of the microdevice from the surgery specimen with sufficient amount and quality of tissue for histopathology analysis and interpretation of at least 50% of the microdevice reservoirs. For Cohort 2, feasibility is defined as successful microdevice placement and the successful retrieval of at least one microdevice per patient with sufficient amount and quality of tissue for histopathology analysis and interpretation of at least 50% of the reservoirs on that microdevice.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenxin Xu, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Implantable Microdevice (IMD) in people with Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by Oliver Jonas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenxin Xu, MD (617-632-6534, Wenxin_Xu1@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of microdevice implantation (time frame: Up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.