Total Consolidative Metastasis and Primary-directed Therapy for Renal Cell Carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-randomized, open-label phase II study evaluating 12-month treatment-free survival after total consolidative MPDT in patients with metastatic clear cell RCC who have partial response or stable disease after ≥6 months of immune checkpoint blockade. Eligible participants will have five or fewer metastases and disease amenable to focal therapy, with clear cell histology and good performance status. The trial uses a multidisciplinary approach to deliver consolidative local therapies, followed by discontinuation of systemic treatment to assess if prolonged disease control is possible. Outcomes will compare observed 12-month treatment-free survival against a predefined null hypothesis, with tissue from prior treatment used for correlative analysis. Management decisions and enrollment are centered at Abramson Cancer Center at Penn Medicine in Philadelphia.

Why it matters

Who can join: the full rules

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.

Where it's running

• Abramson Cancer Center at University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Naomi Haas, MD — Penn Medicine
• Study coordinator: Matthew Doyle
• Email: Matthew.Doyle@Pennmedicine.upenn.edu
• Phone: 610-357-6354

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.