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

Conditions

• Clear Cell Renal Cell Carcinoma
• Renal Cell Carcinoma (RCC)
• Stage II Renal Pelvis Cancer AJCC v8
• Stage III Renal Pelvis Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — BIOLOGICAL
  Given intravenously
• Tivozanib — DRUG
  Given orally
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• MRI — PROCEDURE
  Undergo MRI
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Biopsy — PROCEDURE
  Undergo biopsy
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Mar 14, 2025

Status verified

Jun 2026

Primary completion

Nov 30, 2037

Completion

Nov 30, 2037

Study Design

Enrollment

1,040 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1 (Pembrolizumab)
  Patients receive pembrolizumab IV on days 1 and 43 of each cycle, or on days 1, 22, 43 and 64 of each cycle. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI or CT throughout the trial and may undergo tissue biopsy on study.
• Experimental: Arm 2 (pembrolizumab + tivozanib)
  Patients receive pembrolizumab IV on days 1 and 43 of each cycle and tivozanib PO QD on days 1-21, days 29-49, and days 57-77 of each cycle for up to 6 months. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI or CT throughout the trial and may undergo tissue biopsy on study.

Primary Outcome Measure

Disease-free survival (DFS) [ Time Frame: From time of randomization until disease recurrence or death, assessed up to 10 years ]

Central Contacts

• Aishwarya Vijendran
  773-702-9171
  [email protected]

Locations (414)

Find similar trials in Phoenix, AZ

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