65 Participants Needed

Triple Drug Therapy for Kidney Cancer

Recruiting at 12 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot have had any systemic therapy for kidney cancer within 4 weeks before starting the trial, and certain medications like herbal therapies must be stopped at least 1 week before. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drugs Atezolizumab, Tecentriq, Bevacizumab, Avastin, Erlotinib, and Tarceva for kidney cancer?

Bevacizumab, one of the drugs in the treatment, has shown effectiveness in improving progression-free survival in patients with metastatic renal cell carcinoma when combined with interferon, according to a phase 3 study.12345

Is the triple drug therapy for kidney cancer safe for humans?

The safety of the drugs Atezolizumab, Bevacizumab, and Erlotinib has been studied in various conditions. Bevacizumab, for example, has been approved for use in kidney cancer and is generally safe, but it can cause side effects like bleeding, high blood pressure, and blood clots. Managing these side effects is important to ensure patient safety and quality of life during treatment.46789

How is the triple drug therapy for kidney cancer unique?

The triple drug therapy for kidney cancer combines Atezolizumab, Bevacizumab, and Erlotinib, which is unique because it targets multiple pathways involved in cancer growth and spread, including the immune system, blood vessel formation, and cell growth signals, potentially offering a more comprehensive approach than single or dual therapies.25101112

What is the purpose of this trial?

This phase II trial studies the effects of combination therapy with bevacizumab, erlotinib, and atezolizumab in treating patients with hereditary leiomyomatosis and kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Bevacizumab is in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Combination therapy with bevacizumab, erlotinib, and atezolizumab may stabilize or shrink advanced hereditary leiomyomatosis and kidney cancer.

Research Team

RS

Ramaprasad Srinivasan

Principal Investigator

National Cancer Institute LAO

Eligibility Criteria

This trial is for individuals aged 12 or older with advanced kidney cancer, including hereditary leiomyomatosis and renal cell carcinoma. Participants must have measurable disease, acceptable organ function, no more than two prior VEGF-targeted treatments, and no recent use of certain medications or therapies. Those with treated brain metastases stable for at least 3 months can join. Pregnant women and tobacco users who cannot quit are excluded.

Inclusion Criteria

Your bilirubin levels need to be within a certain range, unless you have Gilbert's disease.
I can provide a tissue sample from my tumor or am willing to have a biopsy.
I have had 2 or fewer treatments targeting VEGF but no bevacizumab for my advanced cancer.
See 15 more

Exclusion Criteria

I haven't had radiotherapy for kidney cancer in the last 2 weeks.
I haven't taken any immune-weakening medications in the last 2 weeks.
I have not had major surgery in the last 28 days.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive bevacizumab, erlotinib, and atezolizumab in 21-day cycles

Up to 2 years
1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 6 months
2 visits per year (in-person)

Treatment Details

Interventions

  • Atezolizumab
  • Bevacizumab
  • Erlotinib
Trial Overview The study tests a combination therapy using bevacizumab (stops blood vessels from feeding tumors), erlotinib (blocks proteins that signal cancer cells to multiply), and atezolizumab (boosts the immune system to fight cancer). The goal is to see if this trio can stabilize or shrink advanced-stage kidney cancers.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (bevacizumab, atezolizumab, erlotinib)Experimental Treatment11 Interventions
Patients receive bevacizumab IV over 30-90 minutes and atezolizumab IV over 30-60 minutes on day 1 of each cycle. Patients also receive erlotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT with or without contrast and MRI throughout the trial. Patients undergo collection of blood throughout the trial, and may undergo a biopsy during screening, as well as a brain MRI/CT scan with contrast, bone scan, and/or F-18 sodium fluoride PET scan as clinically indicated.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tecentriq for:
  • Melanoma
  • Hepatocellular carcinoma
  • Small cell lung cancer
  • Non-small cell lung cancer
  • Urothelial carcinoma
🇪🇺
Approved in European Union as Tecentriq for:
  • 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?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a phase 3 trial involving 628 patients with metastatic renal cell carcinoma, the combination of bevacizumab and interferon (BEV+IFN) significantly improved progression-free survival (PFS) compared to interferon alone, with median PFS of 10.2 months versus 4.6 months (p < 0.001).
A new predictive model based on factors like age and performance status showed better ability to predict individual PFS than the existing Motzer criteria, indicating it could help identify patients who would benefit most from BEV+IFN treatment.
Prediction of progression-free survival rates after bevacizumab plus interferon versus interferon alone in patients with metastatic renal cell carcinoma: comparison of a nomogram to the Motzer criteria.Karakiewicz, PI., Sun, M., Bellmunt, J., et al.[2015]
Targeted therapies, including multikinase inhibitors like sunitinib and sorafenib, have become the primary treatment options for metastatic renal cell carcinoma (RCC), showing significant efficacy in clinical trials compared to traditional immunotherapy.
Sunitinib is the first-line treatment for metastatic RCC, while temsirolimus is recommended for poor-prognosis patients, highlighting the importance of personalized treatment approaches based on patient characteristics.
New treatment approaches in renal cell carcinoma.Facchini, G., Perri, F., Caraglia, M., et al.[2021]
Recent advances in understanding the molecular mechanisms of renal cell carcinoma have led to the development of targeted therapies, including VEGF inhibitors like bevacizumab and tyrosine kinase inhibitors such as sunitinib and pazopanib, which have shown efficacy in Phase III trials.
The review also highlights the importance of optimizing treatment management strategies, including determining the appropriate timing for starting and stopping therapy, as well as exploring alternative dosing schedules for sunitinib.
Clinical management of metastatic kidney cancer: the role of new molecular drugs.Vitale, MG., Cartenì, G.[2021]

References

Prediction of progression-free survival rates after bevacizumab plus interferon versus interferon alone in patients with metastatic renal cell carcinoma: comparison of a nomogram to the Motzer criteria. [2015]
New treatment approaches in renal cell carcinoma. [2021]
Clinical management of metastatic kidney cancer: the role of new molecular drugs. [2021]
Optimizing patient adherence to targeted therapies in renal cell carcinoma. [2014]
Progress and contrasts of the development of tivozanib for therapy of kidney cancer. [2014]
[Management of side effects associated with antiangiogenic treatment in renal cell carcinoma]. [2018]
Management of adverse events associated with cabozantinib plus nivolumab in renal cell carcinoma: A review. [2023]
Analysis of Anti-Angiogenesis-Related Adverse Events Associated with Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitors (VEGFR-TKIs) in Patients with Metastatic Renal Cell Carcinoma. [2023]
FDA drug approval summary: bevacizumab plus interferon for advanced renal cell carcinoma. [2021]
Targeted therapies in metastatic renal cancer in 2009. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Targeting growth factor and antiangiogenic pathways in clear-cell renal cell carcinoma: rationale and ongoing trials. [2019]
Update on the medical treatment of metastatic renal cell carcinoma. [2008]
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