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| ID | Type | Description | Link |
|---|---|---|---|
| IRB#857362 | Other Identifier | [University of Pennsylvania IRB |
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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%
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total consolidative MPDT | Experimental | Participants will discontinue systemic anti-cancer therapy for metastatic RCC, and standard of care definitive procedures or metastatic RCC. These procedures include one or more of the following: surgery (e.g. nephrectomy, metastasectomy, lymph node dissection), percutaneous cryoablation and/or radiotherapy (SAbR or other definitive radiotherapy). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total consolidative MPDT | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival | Recurrence-free survival, defined as the time from completion of total consolidative MPDT until investigator-assessed disease recurrence. | From completion of total consolidative MPDT until investigator-assessed disease recurrence, assessed up to 60 months.. |
| Grade 3 or higher adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Identify an immune signature that correlates with treatment free survival | The investigators will broadly interrogate immune cell types from the peripheral blood and tumor tissue | At week 6 and week 12 following systemic therapy initiation, at the time of study enrollment and following total consolidative MPDT, through study completion, estimated to be 36 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Doyle | Contact | 610-357-6354 | Matthew.Doyle@Pennmedicine.upenn.edu | |
| Naomi Haas, MD | Contact | 2156627615 | Naomi.Haas@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Naomi Haas, MD | Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center at University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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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) |
| From completion of total consolidative MPDT until investigator-assessed disease recurrence, assessed up to 60 months. |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |