UPCC 33824 A Phase II Study of Total Consolidative Metastasis-and-Primary Directed Therapy for Renal Cell Carcinoma

Investigating Treatment for Kidney Cancer with Targeted Approach

Enrolling By Invitation
18 years or above
All
Phase N/A
23 participants needed
1 Location

Brief description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Renal Cell Carcinoma
  • Age: 18 years or above
  • Gender: All

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.

This study investigates a treatment approach for renal cell carcinoma that has spread to other parts of the body. The purpose of this study is to evaluate the effectiveness of a specific therapy called total consolidative metastasis-and-primary directed therapy (MPDT) in patients who have shown stable disease or partial response after at least six months of immune checkpoint therapy. Immune checkpoint therapy is a type of treatment that helps the body's immune system recognize and attack cancer cells.

Participants in this study will undergo MPDT, which involves targeted treatment of both the primary tumor and any metastases, followed by a period without systemic therapy. This approach aims to improve the 12-month treatment-free survival rate. The study will monitor the participants' response to this therapy approach, with the goal of understanding its impact on cancer progression.

  • Who can participate: Adults diagnosed with clear cell renal cell carcinoma, having 5 or fewer metastases, and showing stable disease or partial response after immune checkpoint therapy can participate. Participants must have tissue samples available for comparison and meet specific health criteria.
  • Study details: Participants will undergo total consolidative metastasis-and-primary directed therapy. This involves treating both the main tumor and any spread of the cancer with a focus on consolidating the response achieved with prior therapy.
Updated on 28 Jul 2026. Study ID: 24-2035
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