Consolidative Metastasis and Primary Directed Therapy (MPDT) for Renal Cell Carcinoma (RCC)

Official title

A Phase II Study of Total Consolidative Metastasis-and-primary Directed Therapy (MPDT) for Renal Cell Carcinoma (RCC).

Overview

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%

Interventions

• Procedure Total consolidative MPDT
  After stopping systemic anti-cancer therapy for metastatic RCC, participant will receive one or more of the following: surgery (e.g. nephrectomy, metastasectomy, lymph node dissection), percutaneous cryoablation and/or radiotherapy (SAbR or other definitive radiotherapy).

Primary outcome measures

• Treatment-free survival [Time frame: From discontinuation of anti-cancer therapy until resumption of systemic therapy, first date of additional focally-directed therapy or death, whichever comes first, assessed up to 60 months.]

Secondary outcome measures (2)

• Recurrence-free survival [Time frame: From completion of total consolidative MPDT until investigator-assessed disease recurrence, assessed up to 60 months..]
• Grade 3 or higher adverse events [Time frame: From completion of total consolidative MPDT until investigator-assessed disease recurrence, assessed up to 60 months.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Abramson Cancer Center at University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT06770855 · UPCC 33824 · IRB#857362

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗