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%
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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).
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States
Treatment-free survival
Treatment-free survival, defined as the time from discontinuation of anti-cancer therapy until either: 1) the resumption of systemic therapy; 2) the first date of additional focally-directed therapy; or 3) death.
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.
Recurrence-free survival
Recurrence-free survival, defined as the time from completion of total consolidative MPDT until investigator-assessed disease recurrence.
Time frame: From completion of total consolidative MPDT until investigator-assessed disease recurrence, assessed up to 60 months..
Grade 3 or higher adverse events
Grade 3 or higher adverse events according to the Clavien-Dindo scale (surgery), Society for Interventional Radiology scale (percutaneous cryoablation), or the CTCAE v5.0 (radiotherapy)
Time frame: From completion of total consolidative MPDT until investigator-assessed disease recurrence, assessed up to 60 months.
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