Tivozanib and Pembrolizumab for Advanced Kidney Cancer

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.
Ready to participate?

Review the details below, then apply to join this clinical 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
Who this trial is looking for

This trial is looking for patients with high-risk kidney cancer who have had surgery to remove their tumor. Participants will receive a combination of two drugs, Tivozanib and Pembrolizumab, to see if this treatment works better than Pembrolizumab alone.

Are You a Good Fit for This Trial?
Rules you out Active autoimmune diseaseSevere liver disease

You may be able to join if

  • I have been diagnosed with clear cell renal cell carcinoma.
  • I have had surgery to remove my kidney tumor.
  • I am 18 years or older.
  • I have a good performance status and can take care of myself.
  • I have normal blood counts.
  • I have no signs of cancer left after treatment.
  • I am not pregnant or nursing.
  • I have had no prior treatments for kidney cancer.

You may not be able to join if

  • I have a serious heart condition.
  • I have uncontrolled high blood pressure.
  • I have had a significant infection recently.
  • I have a history of severe bleeding disorders.
  • I have active autoimmune disease requiring treatment.
  • I have a recent serious or non-healing wound.
  • I have had several specific health issues in the last month.
  • I am currently taking certain strong medications that suppress my immune system.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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

Aishwarya Vijendran

773-702-9171

guprotocols@alliancenctn.org

CONTACT