Nivolumab + Ipilimumab for Renal Cell Carcinoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether the timing of standard treatments, nivolumab and ipilimumab (both immunotherapy drugs), affects their effectiveness and side effects in people with advanced kidney cancer. Researchers aim to determine if receiving these treatments in the morning or afternoon influences outcomes, possibly due to the body's natural circadian rhythm. Individuals with advanced clear cell kidney cancer who qualify for standard treatment may be suitable participants, particularly if they can attend morning or afternoon clinic visits. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
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 well-tolerated by patients with advanced kidney cancer. Studies have found that this treatment improves survival rates and provides lasting benefits compared to other treatments like sunitinib.
Regarding safety, earlier research indicated that patients on this treatment had a median time of about 9.9 months before their cancer worsened, with more than half maintaining this state for over a year. This suggests the treatment is relatively safe, although some side effects may occur, which are common with many cancer treatments. As with any treatment, individual experiences can vary, so healthcare providers will closely monitor patients to manage side effects effectively.12345Why are researchers excited about this trial?
Researchers are excited about using Nivolumab and Ipilimumab together for renal cell carcinoma because these drugs harness the power of the immune system to fight cancer in a unique way. Unlike standard treatments that may include targeted therapies or tyrosine kinase inhibitors, these drugs are immune checkpoint inhibitors (ICIs) that work by blocking proteins that prevent the immune system from attacking cancer cells. This approach can potentially lead to more durable and long-lasting responses. Additionally, the trial is exploring the timing of administration, which could optimize the effectiveness of these drugs by aligning with the body's natural rhythms.
What evidence suggests that this trial's treatments could be effective for advanced kidney cancer?
Studies have shown that using nivolumab and ipilimumab together effectively treats advanced kidney cancer. Research indicates that patients receiving this combination can experience long-term benefits. In some studies, this treatment improved outcomes for patients with advanced kidney cancer, also known as renal cell carcinoma (RCC). Data from real-world settings also support its effectiveness and safety. This trial will compare administering this combination therapy at different times of the day. Participants in Arm A will receive the treatment in the morning, while those in Arm B will receive it in the afternoon. This treatment targets specific proteins that help the body's immune system fight cancer cells. Overall, evidence suggests that nivolumab and ipilimumab together can be a powerful option for those with advanced kidney cancer.12678
Are You a Good Fit for This Trial?
Adults over 18 with advanced clear cell kidney cancer can join this trial. They must be able to consent, have measurable disease, and a performance status showing they're still active. Participants need to follow the infusion schedule either in the morning or afternoon.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard-of-care therapy (ICI/ICI) administered either in the morning or afternoon based on randomization
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
Trial Overview
The study tests if taking nivolumab-ipilimumab (ICI/ICI) for kidney cancer at different times of day affects its effectiveness or side effects. Patients will randomly receive treatment either before 11:30am or after 1:30pm as part of their standard care.
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants will receive standard-of-care therapy (ICI/ICI) administered in the afternoon (after 1:30pm).
Participants will receive standard-of-care therapy (ICI/ICI) administered in the morning (before 11:30am).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Guliz Ozgun
Lead Sponsor
British Columbia Cancer Agency
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 ...
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 with I/P-risk mRCC.
Real World Efficacy of 1st Line Nivolumab plus Ipilimumab ...
This study included 455 patients with histologically confirmed advanced RCC who received 1st line nivolumab + ipilimumab between 2018 and 2022 ...
Nationwide Real-World Outcomes of Trial Eligible and ...
Clinical trials have demonstrated efficacy and safety of immune checkpoint inhibitor-based combination therapy in metastatic renal cell carcinoma (mRCC).
5.
cancernetwork.com
cancernetwork.com/view/nivolumab-combo-may-show-long-term-benefits-in-advanced-rccNivolumab Combo May Show Long-Term Benefits in ...
Combining nivolumab (Opdivo) with ipilimumab (Yervoy) may potentially improve long-term outcomes in patients with advanced renal cell carcinoma (RCC).
ASCO 2025: Nivolumab plus Ipilimumab vs Sunitinib for ...
NIVO + IPI continued to demonstrate improved survival with complete and durable response benefits compared with sunitinib in the overall study ...
Efficacy and safety of nivolumab plus ipilimumab in ...
Conclusion Nivo/ipi produced favorable outcomes in patients with pRCC supporting its use as 1 L therapy. Responses in patients with chRCC were ...
The Effectiveness and Safety Profile of Nivolumab‐Plus ...
Among responders, 63.3% had progression-free survival > 12 months. The median progression-free survival was 9.9 months; the 12-month overall ...
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