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Renal Retention in High Grade Upper Tract Urothelial Cancer

StatusRecruiting
PhasePhase 2
Started2024-11-25
View on ClinicalTrials.gov ↗

Amendment history

2026-01-07
Study Status, Sponsor/Collaborators v9
Collaborators-55 characters
Astellas Pharma Inc Seagen Inc. Merck Sharp & Dohme LLC
2024-12-10
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v8
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-12→confirmed 2024-11-25
Eligibility criteria-771 characters
[...] 12 months from completion of therapy are permitted Subjects mustmay have noradiographic evidence of metastaticN1 disease or(Metastasis clinically enlarged lymph nodes on CT or MRI of the abdomen and pelvis and CT chest obtained within 28 days of registration (A negative biopsy is required for lymph nodes ≥ 1.5≤2 cm in sizegreatest todimension, confirmin lacka of involvement). Patients withsingle lymph nodes ≥ 1.5 cm in whom a biopsy is deemed not feasible are not eligible.node) Patients with elevated alkaline phosphatase or suspicious bone pain should also undergo baseline bone scans to evalua [...] [...]
Study sitesdetails revised at 2 of 2 sites
2024-10-16
Study Status v7
Primary completion date2027-06→2028-06
Completion date2028-06→2029-06
Start date2024-07→2024-12
2024-01-12
Study Identification, Study Status v6
Primary completion date2026-06→2027-06
Completion date2027-06→2028-06
Start date2023-12→2024-07
2023-10-20
Study Status v5
Start date2023-09→2023-12
Show 4 earlier versions
2023-07-17
Study Status v4
Start date2023-06→2023-09
2023-05-24
Study Status v3
Primary completion date2026-03→2026-06
Completion date2027-03→2027-06
Start date2023-04→2023-06
2023-03-28
Study Status v2
Start date2023-02→2023-04
2023-01-05
Study Status, Study Description v1
Primary completion date2026-01→2026-03
Completion date2027-01→2027-03
Start date2023-01→2023-02
2022-12-16
Original filing
This trial will evaluate the use of combination pembrolizumab and enfortumab vedotin for patients with high grade non-metastatic (cN0/NxMx, no measurable regional lymph nodes, no metastases) upper tract urothelial cancer (UTUC), preferring to forego standard of care radical nephroureterectomy (RNU) surgery. Currently these patients would not be suitable candidates for neoadjuvant trials, as the patients intention is to forego surgery. The patients are also not candidates for metastatic trials, as the patients have no measurable metastasis. The Investigators hypothesize the combination of pembrolizumab and enfortumab vedotin for patients with high grade cN0/NxMx UTUC deferring RNU will lead to event free survival outcomes similar to that achieved by RNU in a historic dataset.
Trial Details
NCT Number NCT05656235
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions High Grade Urothelial Carcinoma, Bladder Cancer, Urothelial Carcinoma Bladder
Enrollment 20 participants
Start Date 2024-11-25
Primary Completion 2028-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-01-08