Renal Cell Carcinoma
Conditions
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%
Interventions
PROCEDURETotal 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).
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-free survival | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival | From completion of total consolidative MPDT until investigator-assessed disease recurrence, assessed up to 60 months.. | Recurrence-free survival, defined as the time from completion of total consolidative MPDT until investigator-assessed disease recurrence. |
| Grade 3 or higher adverse events | From completion of total consolidative MPDT until investigator-assessed disease recurrence, assessed up to 60 months. | 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) |
Countries
United States
Contacts
CONTACTMatthew Doyle
CONTACTNaomi Haas, MD
PRINCIPAL_INVESTIGATORNaomi Haas, MD
Penn Medicine
Outcome results
None listed