NCT06770855 Consolidative Metastasis and Primary Directed Therapy (MPDT) for Renal Cell Carcinoma (RCC)
| NCT ID | NCT06770855 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | Renal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2026-06-12 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 23 participants in total. It began in 2026-06-12 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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%
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Contact & Investigator
Naomi Haas, MD
PRINCIPAL INVESTIGATOR
Penn Medicine
Frequently Asked Questions
Who can join the NCT06770855 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06770855 currently recruiting?
Yes, NCT06770855 is actively recruiting participants. Contact the research team at Matthew.Doyle@Pennmedicine.upenn.edu for enrollment information.
Where is the NCT06770855 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06770855 clinical trial?
NCT06770855 is sponsored by Abramson Cancer Center at Penn Medicine. The principal investigator is Naomi Haas, MD at Penn Medicine. The trial plans to enroll 23 participants.