Triple Drug Therapy for Kidney Cancer with Brain Metastases

Recruiting in Palo Alto (17 mi)

Overseen by Jianbo Wang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

A Phase II Study of Nivolumab with Ipilimumab and Cabozantinib in Patients with Untreated Renal Cell Carcinoma Brain Metastases

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

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had any approved anticancer therapy, including chemotherapy and hormonal therapy, within 4 weeks prior to starting the study treatment, except for hormone-replacement therapy or oral contraceptives. Herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to the study. Please consult with the trial coordinators for specific guidance on your medications.

What data supports the idea that Triple Drug Therapy for Kidney Cancer with Brain Metastases is an effective treatment?

The available research shows that cabozantinib, one of the drugs in the Triple Drug Therapy, has shown remarkable responses in two cases of kidney cancer with brain metastases. This suggests that the therapy could be effective for this condition. However, there is no specific data comparing this therapy to other treatments for kidney cancer with brain metastases in the provided information.

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What safety data exists for the combination of Nivolumab, Ipilimumab, and Cabozantinib in kidney cancer treatment?

The safety data for the combination of Nivolumab, Ipilimumab, and Cabozantinib in kidney cancer treatment is explored in several studies. One study compares adverse events between Cabozantinib plus Nivolumab and Ipilimumab plus Nivolumab, highlighting differences in safety profiles. Another study assesses the safety of Cabozantinib plus Nivolumab in a phase II trial for non-clear-cell renal cell carcinoma. However, the safety of the triple combination specifically in kidney cancer with brain metastases is not directly addressed in the provided research.

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Is the drug combination of Nivolumab, Ipilimumab, and Cabozantinib a promising treatment for kidney cancer with brain metastases?

Yes, the combination of Nivolumab, Ipilimumab, and Cabozantinib is considered promising for kidney cancer, especially with new research showing potential benefits in treating advanced cases. This combination is seen as a potential new option for patients, marking a significant step forward in treatment possibilities.

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Eligibility Criteria

This trial is for adults with untreated brain metastases from renal cell carcinoma. Participants should have a measurable brain lesion, be in good physical condition (ECOG 0-2), and not need immediate local therapy. They must have normal organ function and agree to contraception if applicable. Exclusions include recent radiation or systemic cancer treatments, significant liver disease, metal implants preventing MRI scans, symptomatic brain metastases needing urgent treatment, certain infections or vaccinations recently, other cancers within the last 5 years, autoimmune diseases.

Inclusion Criteria

I agree to use effective birth control during and for 12 months after treatment.

The size of the tumor is between 5mm and 30mm, as seen on an MRI scan with a special dye.

I have had treatments for kidney cancer that has spread, but not with anti-CTLA-4, cabozantinib, or MET inhibitors.

Exclusion Criteria

I have cancer that has spread to the lining of my brain and spinal cord.

I have never had lung conditions like pulmonary fibrosis or pneumonitis.

My side effects from cancer treatment are mild, except for hair loss.

Participant Groups

The study tests a combination of Nivolumab (an immunotherapy drug), Ipilimumab (another immunotherapy), and Cabozantinib (a medication targeting specific proteins in cancer cells) on patients who haven't treated their kidney cancer's spread to the brain yet. It aims to see how well this combo works together.

Group I: Nivolumab Experimental Treatment 3 Interventions

by vein every 3 weeks for 4 doses

Group II: Ipilimumab Experimental Treatment 3 Interventions

by vein over 30 minutes every 3 weeks for 4 doses

Group III: Cabozantinib Experimental Treatment 3 Interventions

tablets by mouth 1 time every day.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

Bristol-Myers Squibb Industry Sponsor

Exelixis Industry Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Cabozantinib plus Nivolumab and Ipilimumab in Renal-Cell Carcinoma. [2023] The efficacy and safety of treatment with cabozantinib in combination with nivolumab and ipilimumab in patients with previously untreated advanced renal-cell carcinoma are unknown.

2. Australia pubmed.ncbi.nlm.nih.gov

Complete response of metastatic papillary renal cell carcinoma with inferior vena cava tumor thrombus to nivolumab plus cabozantinib. [2023] The effectiveness of nivolumab plus cabozantinib for metastatic papillary renal cell carcinoma with inferior vena cava tumor thrombus remains unclear.

3. Australia pubmed.ncbi.nlm.nih.gov

Efficacy of cabozantinib therapy for brain metastases from renal cell carcinoma. [2022] We report two cases of renal cell carcinoma with brain metastases that showed remarkable responses to cabozantinib.

4. United States pubmed.ncbi.nlm.nih.gov

Effect of Targeted Therapies on Prognostic Factors, Patterns of Care, and Survival in Patients With Renal Cell Carcinoma and Brain Metastases. [2022] To identify prognostic factors, define evolving patterns of care, and the effect of targeted therapies in a larger contemporary cohort of renal cell carcinoma (RCC) patients with new brain metastases (BM).

5. Switzerland pubmed.ncbi.nlm.nih.gov

Neoadjuvant nivolumab and cabozantinib in advanced renal cell carcinoma in a horseshoe kidney - how to achieve a safe and radical resection? a case report and review of the literature. [2023] Neoadjuvant nivolumab and cabozantinib in locally advanced renal cell carcinoma in a horseshoe kidney is a novel therapeutic approach in the preoperative setting.

6. United States pubmed.ncbi.nlm.nih.gov

Adverse Events of Cabozantinib Plus Nivolumab Versus Ipilimumab Plus Nivolumab. [2023] Recently, many agents and combinations for metastatic and advanced renal cell carcinoma have been approved. This study aims to highlight the comprehensive differences in adverse events (AEs) between cabozantinib (CAB) plus nivolumab (NIVO) and ipilimumab (IPI) plus NIVO based on a real-world big dataset.

7. United States pubmed.ncbi.nlm.nih.gov

Phase II Trial of Cabozantinib Plus Nivolumab in Patients With Non-Clear-Cell Renal Cell Carcinoma and Genomic Correlates. [2023] To assess the efficacy and safety of cabozantinib plus nivolumab in a phase II trial in patients with non-clear-cell renal cell carcinoma (RCC).

8. United States pubmed.ncbi.nlm.nih.gov

Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma. [2022] The efficacy and safety of nivolumab plus cabozantinib as compared with those of sunitinib in the treatment of previously untreated advanced renal-cell carcinoma are not known.

9. England pubmed.ncbi.nlm.nih.gov

Less is More? First Impressions From COSMIC-313. [2023] The COSMIC-313 phase 3 randomized controlled trial tested the triplet combination of cabozantinib with nivolumab and ipilimumab in comparison with nivolumab plus ipilimumab control as fist-line systemic therapy in metastatic clear cell renal cell carcinoma. The first results presented at the 2022 European Society of Medical Oncology Congress are a milestone for the renal cell carcinoma field because they signal the advent of triplet combinations as potential treatment options for our patients. The present commentary highlights some considerations and potential next steps based on these first impressions.

10. England pubmed.ncbi.nlm.nih.gov

Cabozantinib and nivolumab as first-line treatment in advanced renal cell carcinoma. [2022] In the last decade, there have been substantial changes in the management of metastatic renal cell carcinoma (mRCC) with combined regimens with immune checkpoint inhibitors (ICI) replacing targeted therapies. These combined regimens include the combination of cabozantinib plus nivolumab.