Nivolumab + Ipilimumab Timing for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two drugs, Nivolumab and Ipilimumab, for advanced kidney cancer. Researchers aim to determine the effectiveness of these drugs when administered at different times. Participants will begin with Nivolumab and, depending on their response, may continue with just this drug or add Ipilimumab. The trial seeks individuals with advanced kidney cancer that cannot be surgically removed and who have not previously used certain immune therapies. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial requires stopping certain medications before starting, such as small molecule kinase inhibitors and some immunosuppressive drugs, at least 2-4 weeks prior. However, some medications like low-dose steroids and certain topical treatments are allowed. 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 patients taking nivolumab, or a combination of nivolumab and ipilimumab, generally tolerate these treatments well, though some risks exist. Serious side effects of nivolumab can include kidney problems, lung inflammation, and digestive issues like diarrhea.
The combination of nivolumab and ipilimumab has demonstrated promising results in treating advanced kidney cancer, reducing the risk of death by 28% compared to sunitinib. However, side effects include liver inflammation in about 7% of patients, with 1.2% experiencing a severe reaction.
Overall, these treatments have been studied extensively and have proven effective and reasonably safe for many patients. It is important to consider potential side effects and consult a healthcare professional to understand their implications.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using nivolumab and ipilimumab for kidney cancer because these immunotherapy drugs work by supercharging the body's immune system to attack cancer cells more effectively. Unlike traditional chemotherapy, which directly targets and kills all rapidly dividing cells, this combination specifically boosts the immune response to target cancer cells. Nivolumab blocks the PD-1 pathway, preventing cancer cells from evading the immune system, while ipilimumab targets CTLA-4, another immune checkpoint, enhancing the immune attack on the tumor. This dual mechanism offers a novel approach that could potentially improve outcomes for patients with certain types of kidney cancer.
What evidence suggests that this trial's treatments could be effective for advanced renal cell cancer?
Research shows that using the drugs nivolumab and ipilimumab together can greatly help people with advanced kidney cancer. In this trial, some participants will receive this combination therapy, which studies have shown reduces the risk of death by 28% compared to sunitinib. Patients on this combination also experienced better control over tumor growth. More than half of those on this treatment had a lower risk of dying compared to those on sunitinib. These findings suggest that this treatment pair can improve survival chances for individuals with advanced kidney cancer.45678
Who Is on the Research Team?
Toni K Choueiri, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with advanced kidney cancer, including those who haven't had their cancer surgically removed or have metastatic RCC. Participants can be new or previously treated but not with certain immune checkpoint inhibitors. They must have measurable disease, good organ function, and provide a tissue sample. Women of childbearing age need a negative pregnancy test and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Initial primary treatment with Nivolumab IV every 2 weeks, with serial imaging assessments every 8 weeks
Arm A: Observation
Patients with persistent response to induction nivolumab are observed with serial imaging every 8 weeks. Nivolumab is resumed if progressive disease develops.
Arm B: Combination Therapy
Patients with SD/PD to induction nivolumab receive combination therapy with nivolumab and ipilimumab, followed by nivolumab alone until disease progression.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Toni Choueiri, MD
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania