NCT06770855Recruiting
Consolidative Metastasis and Primary Directed Therapy (MPDT) for Renal Cell Carcinoma (RCC)
A Phase II Study of Total Consolidative Metastasis-and-primary Directed Therapy (MPDT) for Renal Cell Carcinoma (RCC).
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
This is a non-randomized, open-label phase II study designed to estimate 12-month treatment-free survival rate following total consolidative metastasis-and-primary directed therapy (MPDT) among patients with partial response/stable disease after at least 6 months of immune checkpoint blockade-based therapy for metastatic clear cell RCC. The investigators hypothesize that patients who undergo total consolidative MPDT followed by systemic therapy discontinuation will have a 12-month treatment-free survival rate of 32% compared to a null hypothesis of 13%
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 23 (estimated)
- First submitted
- 23 Dec 2024
- Start date
- 12 Jun 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Diseases
- Kidney cancer
- NCT number
- NCT06770855
What you commit to
- Study type: Interventional
- Planned participants: 23
- From 12 Jun 2026 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who have progressed during the first 6 months of immune checkpoint-blockade based therapy as determined by study investigator.
- Subjects who have a need for urgent focally directed therapy (i.e. symptomatic brain or spinal metastases). Stable spinal metastases resected and/or treated with SBRT in advance of or concurrently with immune checkpoint-blockade based therapy are allowed to participate.
Lab values
- Any female of child-bearing potential who has a positive urine pregnancy test within 72 hours before screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Participants must be excluded/discontinued from the trial in the event of a positive or borderline positive serum pregnancy test result.
Who the study is looking for
- Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma (mixed histology acceptable but must have clear cell component)
- Metastatic clear cell RCC with 5 or fewer metastases at enrollment (excluding pulmonary nodules \<1.0cm)
- Stable disease or partial response as assessed by investigators following at least 6 months of immune checkpoint blockade-based therapy.
- Has disease amenable for total consolidative focal therapy (this will be determined by a multidisciplinary team which may include a combination of medical oncologists, urologists, interventional radiologists, and radiation oncologists).
- ECOG performance status \< 2
- Must have archival tissue (slide or Formalin-Fixed Paraffin-Embedded tissue) preceding prior systemic treatment for comparison to tissue from consolidation
- Consolidation surgery and biopsies are strongly encouraged to be within 42 days +/- 7 days of holding systemic therapy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Abramson Cancer Center at University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.