Neoadjuvant Cabozantinib for Kidney Cancer

Overseen By Viraj Master, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

Must not be taking: Anticoagulants, Platelet inhibitors

Disqualifiers: Metastatic disease, Brain metastases, Cardiovascular disorders, GI disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cabozantinib, a medication, can effectively shrink kidney cancer tumors before surgery. Cabozantinib blocks certain enzymes that promote tumor cell growth. The trial targets individuals with kidney cancer that is large or has spread to nearby areas, but not to distant parts of the body. Ideal participants have renal cell carcinoma with clear cell features and have not received specific cancer treatments previously. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot be on certain anticoagulants (blood thinners) like warfarin or clopidogrel. It's best to discuss your specific medications with the trial team to see if they are allowed.

Is there any evidence suggesting that cabozantinib is likely to be safe for humans?

Studies have shown that cabozantinib is generally safe and well-tolerated for patients with kidney cancer. Earlier research demonstrated that cabozantinib reduced tumor size without causing severe side effects for most people. Another study found the drug effective and safe when used before kidney cancer surgery. While some patients might experience mild to moderate side effects, these are usually manageable. Overall, cabozantinib appears to be a safe option for treating kidney cancer before surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney cancer?

Researchers are excited about cabozantinib for kidney cancer because it targets new pathways. Unlike standard treatments like surgery or other tyrosine kinase inhibitors, cabozantinib is designed to block multiple pathways involved in cancer growth and spread, potentially making it more effective against aggressive tumors. Plus, it's taken orally, which can be more convenient compared to treatments that require hospital visits. This unique approach offers hope for better control of the disease with fewer disruptions to daily life.

What evidence suggests that cabozantinib might be an effective treatment for kidney cancer?

Research has shown that cabozantinib, which participants in this trial will receive, can help treat kidney cancer. In some cases, it reduced tumor size, allowing patients previously ineligible for surgery to consider it. Studies also suggest that cabozantinib may strengthen the body's immune system to fight cancer more effectively. Experts report that it works well for different types of kidney cancer. Overall, cabozantinib appears promising in improving outcomes for kidney cancer patients before surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Mehmet Asim Bilen, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults with advanced kidney cancer that hasn't spread elsewhere. They should be fit enough for daily activities (ECOG ≤ 1), have good organ function, and not have had cancer treatment in the last 5 years. Participants must agree to use contraception and not be pregnant or breastfeeding.

Inclusion Criteria

I am not pregnant and meet the specific criteria for women of childbearing age.

Capable of understanding and complying with the protocol requirements and must have signed the informed consent document

I haven't had cancer treatment like hormonal, chemotherapy, or immunotherapy in the last 5 years.

Exclusion Criteria

There is proof of cancer spreading to other parts of the body on the images taken before starting the treatment.

I haven't had major surgery recently.

I have received treatments like chemotherapy for kidney cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cabozantinib orally once daily for 12 weeks

12 weeks

Regular monitoring visits

Surgery

Participants undergo surgery after completion of cabozantinib treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cabozantinib

Trial Overview The study tests Cabozantinib's effectiveness when given before surgery to patients with locally advanced kidney cancer. It aims to see if this drug can halt tumor growth by blocking enzymes needed for cell proliferation.

How Is the Trial Designed?

Group I: Treatment (cabozantinib) Experimental Treatment 1 Intervention

Patients receive cabozantinib orally once daily for 12 weeks in the absence of disease progression or unacceptable toxicity. The assigned starting dose for cabozantinib is 60 mg/day. Two dose reduction levels of cabozantinib are permitted

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Exelixis

Industry Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7882722/

Neoadjuvant Cabozantinib in an Unresectable Locally ... This is a report of neoadjuvant cabozantinib downsizing a tumor and enabling surgical resection in this patient with locally advanced RCC.

2. winshipcancer.emory.edu winshipcancer.emory.edu/newsroom/articles/2025/winship-study-reveals-pre-surgical-cabozantinib-may-improve-outcomes-in-kidney-cancer.php

Pre-surgical cabozantinib may improve outcomes in kidney ... This research suggests that cabozantinib may not only improve surgical outcomes but also enhance the immune response to cancer, potentially ...

3. kidney-cancer-journal.com kidney-cancer-journal.com/pdf/2025/2025q2/Cabometyx%20Roundtable_KCJ2025.pdf

Cabozantinib in Renal Cell Carcinoma: Clinical Insights and ... The experts provide clinical insights into cabozantinib's attractiveness as a therapy, highlighting its broad applicability across RCC histologies (including ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9169675/

An Evaluation of Cabozantinib for the Treatment of Renal ... The cabozantinib–nivolumab combination also led to an improvement in the ORR (55.7% versus 27.1%; p<0.001), and the complete response rate also ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04022343

Study Details | NCT04022343 | Neoadjuvant Cabozantinib ... A Phase 2 Study of Neoadjuvant Cabozantinib in Patients With Locally Advanced Non-Metastatic Clear Cell Renal Cell Carcinoma. Conditions. Clear Cell Renal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11326393/

Neoadjuvant cabozantinib restores CD8+ T cells in ... Cabozantinib reduces tumor size and is safe in the neoadjuvant setting in ccRCC. Between August 2019 to September 2021, we screened 22 patients. 17 patients had ...

7. urotoday.com urotoday.com/recent-abstracts/urologic-oncology/renal-cancer/158663-neoadjuvant-cabozantinib-for-locally-advanced-nonmetastatic-clear-cell-renal-cell-carcinoma-a-phase-2-trial.html

Neoadjuvant cabozantinib for locally advanced ... The 1-year disease-free survival and overall survival were 82.4% (95% CI 54.7-93.9%) and 94.1% (95% CI 65-99.1%), respectively. Cabozantinib ...

8. nature.com nature.com/articles/s41598-023-48087-4

Efficacy and safety of second-line cabozantinib after ... The IMDC risk at the start of first-line therapy was favorable, intermediate, and poor in 13%, 54%, and 31% of patients, respectively. The ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.6_suppl.340

Phase 2 study of neoadjuvant cabozantinib in patients with ... Conclusions: Cabozantinib was clinically active and safe in the neoadjuvant setting in patients with locally advanced non-metastatic clear cell ...