Drug Screening Using Novel IMD in Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOliver Jonas
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Implantable Microdevice (IMD)
Combination productSmall, 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Implantable microdevice (IMD) + Biopsy + Standard of Care TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Up to 30 days2
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.
Time frame
72 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oliver Jonas
Lead sponsor
Brigham and Women's Hospital
Sponsor institution
Dana-Farber Cancer Institute
Collaborator
Source ClinicalTrials.gov