A Multicenter, Single-Arm Open Label Phase II Trial of Cryoablation in Combination With Pembrolizumab or Avelumab in Patients With Metastatic Urothelial Carcinoma

Who is this study for? Patients with urothelial carcinoma
What treatments are being studied? Pembrolizumab+Cryoablation
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Massachusetts General Hospital Cancer Center
RECRUITING
Boston
Contact Information
Primary
Eric Wehrenberg-Klee, MD
ewehrenberg-klee@partners.org
(617) 724-4000
Time Frame
Start Date: 2021-06-04
Estimated Completion Date: 2025-12
Participants
Target number of participants: 30
Treatments
Experimental: Pembrolizumab/Avelumab + Cryoablation
If patient is receiving pembrolizumab: Participants will be given 200 mg pembrolizumab intravenously once every 3 weeks. This will continue for up to 2 years as per standard of care. Participants will receive cryoablation between the 1st and 2nd doses of pembrolizumab. Cryoablation consists of using a CT scan to guide one or more thin needles to the tumor through your skin, where extreme cold is applied.~If patient is receiving avelumab: Participants will be given 800 mg avelumab intravenously once every 2 weeks. This will continue for up to 2 years as per standard of care. Participants will receive cryoablation between the 1st and 2nd doses of avelumab. Cryoablation consists of using a CT scan to guide one or more thin needles to the tumor through your skin, where extreme cold is applied.
Related Therapeutic Areas
Sponsors
Collaborators: Biocompatibles UK Ltd
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov

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