Nivolumab + Ipilimumab for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This clinical trial tests the safety and effectiveness of combining two immunotherapy drugs, nivolumab and ipilimumab, with a bacterial treatment called EXL01 for treating kidney cancer that has spread. The goal is to determine if EXL01 can enhance the immune system's ability to fight cancer by influencing gut bacteria. The trial includes two groups: one receiving nivolumab and ipilimumab alone, and the other receiving the two drugs with EXL01. It seeks participants with advanced or metastatic kidney cancer who have not previously received these specific immunotherapy drugs. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this novel combination therapy.
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. However, you cannot use probiotics, prebiotics, or certain supplements two weeks before and during the trial. 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 shows that the combination of nivolumab and ipilimumab is generally safe for patients with advanced kidney cancer. Studies have found that while up to 20% of patients might experience disease progression early on, many others benefit from long-lasting effects. This combination also reduces the risk of death by about 28% compared to other treatments.
The current trial for EXL01, a live biotherapeutic product, is in its early stages. The main goal is to assess its safety when used with nivolumab and ipilimumab. Early-phase trials often provide limited safety information, but they are crucial for determining a treatment's safety for people.
In summary, nivolumab and ipilimumab have a strong safety record, while EXL01 is still undergoing safety testing in combination with them.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for kidney cancer because they combine two powerful immunotherapy drugs, nivolumab and ipilimumab, which work together to boost the immune system's ability to fight cancer. Unlike traditional treatments like surgery or targeted therapies, this combination specifically enhances the body's immune response to attack cancer cells more effectively. Additionally, the experimental treatment arm introduces EXL01, an oral medication that might further amplify the immune response, potentially offering a new avenue for improved outcomes. This approach could represent a significant advancement by not only targeting the cancer but also enhancing patients' overall immune surveillance.
What evidence suggests that this trial's treatments could be effective for kidney cancer?
Research has shown that using nivolumab and ipilimumab together can be promising for treating advanced kidney cancer. About 40% of patients experience long-term benefits, while around 20% see their disease worsen early on. Another study found that these drugs lowered the risk of death by 28% compared to a common treatment. In this trial, participants in Arm A will receive a combination of nivolumab, ipilimumab, and EXL01, a beneficial bacteria that might enhance the immune system's ability to fight cancer. Participants in Arm B will receive nivolumab and ipilimumab without EXL01. This combination aims to boost the body's natural defenses against cancer spread.12345
Who Is on the Research Team?
Sumanta K Pal
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for individuals with metastatic renal cell cancer, which means their kidney cancer has spread to other parts of the body. Participants should meet certain health standards but specific inclusion criteria are not provided here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive nivolumab and ipilimumab with or without EXL01 in cycles. Cycles 1-4 repeat every 21 days, and cycles 5+ repeat every 28 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up visits every 3 months.
What Are the Treatments Tested in This Trial?
Interventions
- EXL01
- Ipilimumab
- Nivolumab
Trial Overview
The trial is testing the safety and effectiveness of two immunotherapy drugs, Nivolumab and Ipilimumab, with or without a new treatment called EXL01. It's a phase I study to see if adding EXL01 improves patient responses by changing gut bacteria.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
CYCLES 1-4: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle and receive EXL01 PO QD on days 1-21 of each cycle. Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CYCLES 5+: Patients continue receiving nivolumab IV over 30 minutes on day 1 of each cycle and EXL01 PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and collection of blood samples throughout the study. Patients may undergo MRI at screening and may undergo bone scan as clinically indicated.
CYCLES 1-4: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CYCLES 5+: Patients continue receiving nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and collection of blood samples throughout the study. Patients may undergo MRI at screening and may undergo bone scan as clinically indicated.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Real-World Outcomes in Patients With Metastatic Renal ...
This study provides data to support the understanding of the real-world utilization and long-term effectiveness of 1L NIVO + IPI in patients ...
NCT07128680 | Immunotherapy (Nivolumab and ...
This phase I trial tests the safety and effectiveness of nivolumab and ipilimumab with and without EXL01 for the treatment of renal cell ...
3.
cancerdiagnosisprognosis.org
cancerdiagnosisprognosis.org/article/500/analysis-of-early-progression-in-advanced-renal-cell-carcinoma-treated-with-nivolumab-plus-ipilimumabAnalysis of Early Progression in Advanced Renal Cell ...
Approximately 40% of patients treated with NIVO + IPI experience a durable response, although 20% face early disease progression (EDP) (5).
Eight-Year Data for Opdivo (nivolumab) Plus Yervoy ...
Patients with previously untreated advanced or metastatic renal cell carcinoma treated with Opdivo plus Yervoy experienced a 28% reduction in the risk of death ...
Real-world outcomes of nivolumab plus ipilimumab ...
Regarding an effectiveness profile, median progression-free survival, time to treatment failure and overall survival were 9.01, 12.5 and 49.0 ...
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