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Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer

Study acronym: STRIKE
StatusRecruiting
PhasePhase 3
Started2025-03-14
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
minor
Study Status, Contacts/Locations v14
Trial sites expanded: 421 → 425 locations
2026-08-04
minor
Study Status, Contacts/Locations v13
Trial sites expanded: 415 → 421 locations
2026-07-01
minor
Study Status, Oversight, Eligibility, Contacts/Locations v12
Study sites414→415
Eligibility criteria-1 characters
[...] cipants who have had resection of primary tumor (radical or particalpartial nephrectomy) and resection or definitive radiation or ablat [...]
2026-06-01
minor
Study Status, Contacts/Locations v11
Trial sites expanded: 410 → 414 locations
2026-05-07
minor
Study Status, Contacts/Locations v10
Study sites409→410
2026-04-06
minor
Study Status, Contacts/Locations v9
Trial sites expanded: 399 → 409 locations
2026-03-02
minor
Study Status, Contacts/Locations v8
Study sites393→399
2026-02-03
minor
Study Status, Contacts/Locations v7
Study sites373→393
2026-01-06
minor
Study Status, Contacts/Locations v6
Study sites371→373
2025-12-08
minor
Study Status, Contacts/Locations v5
Study sites361→371
2025-11-04
minor
Study Status, Contacts/Locations v4
Study sites301→361
2025-09-02
minor
Study Status, Contacts/Locations v3
Study sites208→301
2025-06-24
minor
Study Status, Contacts/Locations v2
Study sites62→208
2025-03-28
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Conditions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-11-07→confirmed 2025-03-14
Study sites0→62
2024-10-25
minor
Original filing
This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.
Trial Details
NCT Number NCT06661720
Lead Sponsor Alliance for Clinical Trials in Oncology
Conditions Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma (RCC), Stage II Renal Pelvis Cancer AJCC v8, Stage III Renal Pelvis Cancer AJCC v8
Enrollment 1,040 participants
Start Date 2025-03-14
Primary Completion 2037-11 (estimated)
Study Completion 2037-11 (estimated)
Updated on ClinicalTrials.gov 2026-09-02