Fianlimab + Cemiplimab + Ipilimumab or Ipilimumab + Nivolumab for Kidney Cancer

Overseen By Gabrielle Tiggs

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Brian Rini

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: Autoimmune disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new combinations of treatments for advanced kidney cancer. Researchers are comparing three different treatment groups to determine which works best: one group will receive fianlimab, cemiplimab, and ipilimumab; another will receive fianlimab and cemiplimab; and a third will receive the standard treatment of ipilimumab and nivolumab. The trial seeks participants with advanced clear cell renal cell carcinoma who have not yet undergone systemic therapy. Participants should have kidney cancer that cannot be cured with surgery or radiation and should have measurable disease.

As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to significant advancements in kidney cancer treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of cemiplimab and fianlimab is generally well-tolerated by patients with advanced clear cell kidney cancer. In studies, patients did not encounter unexpected safety issues. This treatment combination led to lasting positive responses in patients who had undergone many previous treatments. Reports indicate that 43.9% of patients experienced serious side effects during treatment, and 32.7% had serious side effects related to the treatment; however, these figures are from a study involving a different type of cancer.

For the combination of cemiplimab, fianlimab, and ipilimumab, specific safety information is limited. However, cemiplimab and fianlimab alone have shown promising safety results. This suggests that adding ipilimumab, already FDA-approved for other uses, might also be manageable, though this is less certain.

Ipilimumab and nivolumab, when used together in another trial group, are FDA-approved for various cancers. These treatments are generally well-tolerated but can have serious side effects, such as immune-related reactions.

Overall, the treatments under study have been researched with safety in mind, but all treatments can have side effects. Participants should consider the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for kidney cancer because they offer unique combinations of immune checkpoint inhibitors that could enhance anti-cancer effects. Unlike the standard of care, which typically involves drugs like sunitinib or pazopanib, these investigational treatments combine cemiplimab with fianlimab and ipilimumab, or nivolumab with ipilimumab, to potentially boost the body's immune response against cancer cells. Cemiplimab and fianlimab, in particular, are being explored for their novel approach to targeting the immune system's pathways, potentially leading to more effective and sustained tumor control. By combining these drugs, researchers hope to improve treatment outcomes and possibly extend survival for patients with this challenging condition.

What evidence suggests that this trial's treatments could be effective for kidney cancer?

Research has shown promising results for the treatments tested in this trial for kidney cancer. Participants may receive cemiplimab and fianlimab together, which studies have found can lead to lasting improvements in patients with clear cell renal cell carcinoma (RCC). This combination has proven well-tolerated and effective, especially for patients who have tried other treatments. Another arm of the trial will examine how adding ipilimumab to cemiplimab and fianlimab might enhance the immune system's ability to fight cancer cells. Additionally, ipilimumab and nivolumab, already known to work well for treating advanced RCC and often used as standard treatments, are being tested in a separate arm. Overall, these therapies are believed to help the body's immune system fight cancer more effectively. ^{2 3 4 5 6}

Who Is on the Research Team?

Brian Rini, MD

Principal Investigator

Vanderbilt-Ingram Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

My kidney cancer cannot be cured with surgery or radiation.

I have signed the consent form and allowed my health information to be shared.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive randomized treatment with either fianlimab/cemiplimab/ipilimumab, fianlimab/cemiplimab, or ipilimumab/nivolumab

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• Fianlimab
• Ipilimumab
• Nivolumab

How Is the Trial Designed?

Group I: Arm B: Cemiplimab and Fianlimab Experimental Treatment 2 Interventions

Cemiplimab and fianlimab will be co-administered by IV.

Group II: Arm A: Cemiplimab, Fianlimab, and Ipilimumab Experimental Treatment 3 Interventions

Cemiplimab and fianlimab will be co-administered by IV. Ipilimumab will be administered by IV.

Group III: Arm C: Nivolumab and Ipilimumab Active Control 2 Interventions

Nivolumab and ipilimumab will be by IV. Nivolumab will be administered by IV after the combination.

Who Is Running the Clinical Trial?

Brian Rini

Lead Sponsor

Vanderbilt-Ingram Cancer Center

Collaborator

Trials

221

Recruited

64,400+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

1.

onclive.com

onclive.com/view/fianlimab-plus-cemiplimab-yields-early-efficacy-signs-in-pretreated-advanced-ccrcc

Fianlimab Plus Cemiplimab Yields Early Efficacy Signs in ...

Treatment with the combination of fianlimab and cemiplimab-rwlc (Libtayo) was well tolerated and led to durable responses in heavily pretreated patients.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07223541

Study Details | NCT07223541 | Cemiplimab or ...

The purpose of this research is to test the safety of PD-1 inhibitor cemiplimab with or without LAG-3 inhibitor fianlimab, and see what effects (good and ...

3.

mskcc.org

mskcc.org/cancer-care/clinical-trials/24-329

A Phase 2 Study of Cemiplimab and Fianlimab Before ...

The patients in this study have large kidney tumors caused by clear cell renal cell carcinoma. This will have to be confirmed with a needle biopsy of the kidney ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11301888/

7 A Phase 1 study of fianlimab (anti–LAG-3) in combination ...

Fianlimab + cemiplimab demonstrated promising signs of clinical activity with durable responses among patients who were anti–PD-(L)1-naïve (cohort 3) and anti– ...

5.

connect.careboxhealth.com

connect.careboxhealth.com/en-US/trial/listing/557016

A Study of Cemiplimab and Fianlimab in People With Clear ...

The researchers are doing this study to find out whether it is practical (feasible) to give cemiplimab and fianlimab before a nephrectomy ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06699602

NCT06699602 | A Study of Cemiplimab and Fianlimab in ...

The researchers will also look at whether cemiplimab and fianlimab given before a nephrectomy is a safe and effective treatment approach and if there is a ...