Atezolizumab + Cabozantinib for Kidney Cancer
(CONTACT-03 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of combining two drugs, atezolizumab (an immunotherapy drug) and cabozantinib, compared to cabozantinib alone for individuals with kidney cancer that cannot be surgically removed and has spread or worsened after previous treatments. It focuses on those whose kidney cancer has progressed despite prior immune-based therapies. Suitable candidates have kidney cancer that has worsened after immune therapy and is in a stage where surgery is not an option. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop any anti-cancer therapy at least 14 days before starting the study treatment. If you are on certain blood thinners like warfarin or clopidogrel, you may also need to stop those. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using atezolizumab with cabozantinib is generally safe for treating advanced kidney cancer. In earlier studies, this combination proved effective without causing serious side effects. Most participants tolerated it well, experiencing manageable side effects. The most common side effects were tiredness and diarrhea, typical for these treatments. Overall, the treatment was considered safe and well-tolerated.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about using atezolizumab combined with cabozantinib for kidney cancer because this duo offers a fresh approach to treatment. Atezolizumab is an immune checkpoint inhibitor that boosts the body's immune response against cancer cells, while cabozantinib is a tyrosine kinase inhibitor that blocks specific pathways necessary for cancer growth. Unlike traditional treatments that often focus on either immune modulation or pathway inhibition alone, this combination targets both, potentially offering a more robust attack on cancer cells. This dual-action approach could lead to better outcomes for patients by simultaneously enhancing the immune response and disrupting cancer cell survival mechanisms.
What evidence suggests that this trial's treatments could be effective for kidney cancer?
Research shows that cabozantinib, which participants in this trial may receive, effectively treats advanced kidney cancer, known as renal cell carcinoma (RCC). It can slow tumor growth in patients with this cancer type. Another treatment option in this trial combines cabozantinib with atezolizumab. Early studies suggested potential extra benefits from this combination. However, more recent research did not find a clear improvement in patient outcomes with the combination compared to cabozantinib alone. Both treatments have generally manageable side effects, meaning they are usually tolerable for patients. Overall, cabozantinib is a reliable option for treating advanced RCC, while more research is needed to determine if adding atezolizumab offers any extra benefits.12345
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
This trial is for adults with advanced renal cell carcinoma who've seen their cancer grow despite previous immune checkpoint inhibitor therapy. They must have a certain level of physical health, no recent other cancer treatments or surgeries, and agree to contraception if applicable. Those with uncontrolled blood pressure, significant heart disease, active infections or hepatitis are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive atezolizumab every 3 weeks and cabozantinib daily, or cabozantinib daily alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Cabozantinib
Atezolizumab is already approved in United States, European Union for the following indications:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Exelixis
Industry Sponsor
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
Chugai
Collaborator
Chugai Pharmaceutical
Industry Sponsor
Dr. Osamu Okuda
Chugai Pharmaceutical
Chief Executive Officer since 2020
MD from Kyoto University
Dr. Mariko Y. Momoi
Chugai Pharmaceutical
Chief Medical Officer
MD from Jichi Medical University