A Multicenter, Single-Arm Open Label Phase II Trial of Cryoablation in Combination With Pembrolizumab or Avelumab in Patients With Metastatic Urothelial Carcinoma
This research study is examining the effectiveness of pembrolizumab plus cryoablation or aveluma plus cryoablation on people with urothelial carcinoma, including bladder cancer, that has spread.
• The subject has read, signed and dated the Informed Consent Form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject.
• Age \> 18 years at date of ICF signature having the ability to comply with the protocol.
• Proof of medical insurance coverage.
• Histologically or cytologically documented metastatic (M1, Stage IV) urothelial carcinoma (including renal pelvis, ureters, urinary bladder, urethra)
• Measurable metastatic disease with at least one site of metastatic disease \> 2 cm in size and amenable to percutaneous image-guided cryoablation based on routine Interventional Radiology criteria. Metastasis sites amenable to cryoablation to include lymph node, peritoneum, liver, soft tissue, adrenal glands, kidney, lung, and bone. Must have measurable disease (by RECIST v1.1) independent of the lesion to be ablated (ie patient must have more than one metastasis)
• Life expectancy \> 12 weeks.
• PS ECOG 0 or 1
• Laboratory requirements:
‣ ANC \> 1 x 109/L
⁃ Platelets \> 75 x 109/L
⁃ ALT / AST \< 5 x ULN
⁃ Total bilirubin \<3 mg/dL
⁃ INR \<1.7
⁃ CrCl \>30 ml/min