Tivozanib + Pembrolizumab for Kidney Cancer

(STRIKE Trial)

Recruiting at 61 trial locations

Overseen By Aishwarya Vijendran

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of 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 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.

Eligibility Criteria

This trial is for patients with high-risk renal cell carcinoma who've had surgery to remove the cancer within the last 4-16 weeks without complications. It's open to those with certain stages and grades of kidney cancer, including cases where it has not spread (M0) or there's no evidence of disease after metastasis treatment.

Inclusion Criteria

My cancer is in stage T3 but hasn't spread to lymph nodes or other parts.

My kidney cancer was confirmed by a lab test and I've had surgery to remove it.

My cancer is large but hasn't spread to lymph nodes or other parts.

Treatment Details

Interventions

• Pembrolizumab (Monoclonal Antibodies)
• Tivozanib (Kinase Inhibitor)

Trial Overview The study is testing if adding Tivozanib, a drug that blocks tumor growth signals, to Pembrolizumab, an immunotherapy drug helping the immune system fight cancer, provides better outcomes than using Pembrolizumab alone after kidney cancer surgery.

Participant Groups

Group I: Arm 2 (pembrolizumab + tivozanib) Experimental Treatment 7 Interventions

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.

Group II: Arm 1 (Pembrolizumab) Active Control 6 Interventions

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.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+