Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer
Recruiting
Phase 3
Interventional Study
Clear Cell Renal Cell Carcinoma
Renal Cell Carcinoma (RCC)
Stage II Renal Pelvis Cancer AJCC v8
Stage III Renal Pelvis Cancer AJCC v8
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,040 (estimated)
- Sponsor
- Alliance for Clinical Trials in Oncology · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* • Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)
* Note: Patients with microscopically positive soft tissue or vascular margins witho…
Contacts