88 Participants Needed

Fianlimab + Cemiplimab + Ipilimumab for Melanoma

Recruiting at 10 trial locations
JS
MP
Overseen ByMichael Postow, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot be on high-dose systemic steroids or other immunosuppressive medications within 14 days of starting the trial treatment.

What data supports the effectiveness of the drug combination Fianlimab, Cemiplimab, and Ipilimumab for treating melanoma?

Research shows that combining drugs like nivolumab and ipilimumab can significantly improve survival and response rates in advanced melanoma patients compared to using ipilimumab alone. This suggests that combining similar drugs, like Fianlimab, Cemiplimab, and Ipilimumab, might also enhance treatment effectiveness.12345

What safety information is available for the combination of Fianlimab, Cemiplimab, and Ipilimumab in treating melanoma?

Ipilimumab, an immune checkpoint inhibitor, can cause immune-related side effects, which are often mild but can sometimes be severe and life-threatening. These side effects are generally manageable with early recognition and treatment, such as using corticosteroids. Combining ipilimumab with other treatments like anti-PD1 agents has shown increased efficacy but also potential for greater toxicity.678910

What makes the drug combination of Fianlimab, Cemiplimab, and Ipilimumab unique for treating melanoma?

The combination of Fianlimab, Cemiplimab, and Ipilimumab is unique because it targets multiple immune checkpoints to enhance the body's immune response against melanoma, potentially offering a more comprehensive approach compared to treatments using fewer drugs. This combination may provide a novel strategy by incorporating Fianlimab, which is not commonly used in existing melanoma treatments.111121314

What is the purpose of this trial?

The purpose of this study is to test whether the combination of fianlimab, cemiplimab, and ipilimumab is a safe and effective treatment that causes few or mild side effects for locally advanced or metastatic, unresectable, refractory melanoma.

Research Team

JS

James Smithy, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for individuals with advanced melanoma that can't be removed by surgery or has spread, and who haven't responded to other treatments. Participants should meet certain health standards but specific inclusion and exclusion criteria are not listed.

Inclusion Criteria

I do not have any symptoms of heart problems.
My kidneys are functioning well enough, with a creatinine clearance rate of at least 30 mL/min.
Patient/legal authorized representative (LAR) must be able to provide informed consent
See 10 more

Exclusion Criteria

History of severe hypersensitivity reactions to any unknown allergens or study drug components
Patients who are breastfeeding or pregnant
I haven't taken antibiotics for a serious infection in the last 2 weeks.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous Fianlimab and Cemiplimab every three weeks and Ipilimumab every six weeks continuously

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Cemiplimab
  • Fianlimab
  • Ipilimumab
Trial Overview The study is examining the safety and effectiveness of combining three drugs: fianlimab, cemiplimab, and ipilimumab in treating melanoma. It aims to determine if this combination leads to fewer or milder side effects while being effective.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Refractory melanoma after combined PD-1 and LAG-3 blockade (Cohort B)Experimental Treatment3 Interventions
All patients will receive intravenous Fianlimab and Cemiplimab every three weeks continuously. Ipilimumab will be given every 6 weeks continuously.
Group II: Refractory melanoma after PD-1 monotherapy (Cohort A)Experimental Treatment3 Interventions
All patients will receive intravenous Fianlimab and Cemiplimab every three weeks continuously. Ipilimumab will be given every 6 weeks continuously.

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

🇪🇺
Approved in European Union as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Non-small cell lung cancer (NSCLC)
🇺🇸
Approved in United States as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Basal cell carcinoma (BCC)
  • Non-small cell lung cancer (NSCLC)
🇨🇦
Approved in Canada as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Non-small cell lung cancer (NSCLC)
🇧🇷
Approved in Brazil as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

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 profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Findings from Research

The combination of nivolumab and ipilimumab, two immune checkpoint inhibitors, is a promising treatment for advanced melanoma, enhancing the body's immune response against the cancer.
Adding denosumab to this treatment may further improve anti-tumor effects by counteracting the immunosuppressive environment created by CD8+ T cells, as suggested by recent reports.
Successful Treatment of Multiple Metastatic Melanoma with Nivolumab, Ipilimumab plus Denosumab Combined Therapy.Yoshida, S., Fujimura, T., Kambayashi, Y., et al.[2020]
In a phase Ib study involving 31 patients with advanced melanoma, the combination of ipilimumab and peginterferon alfa-2b showed a maximum tolerated dose of ipilimumab at 3 mg/kg and peginterferon at 2 μg/kg/week, with a 40% overall response rate.
The treatment had a manageable safety profile, with 45.2% of patients experiencing grade 3 drug-related adverse events, but no severe (grade 4/5) adverse events, indicating that this combination therapy could be a promising option for further investigation.
A phase IB study of ipilimumab with peginterferon alfa-2b in patients with unresectable melanoma.Brohl, AS., Khushalani, NI., Eroglu, Z., et al.[2021]
In a phase 2 trial involving 142 patients with untreated advanced melanoma, the combination of nivolumab and ipilimumab resulted in a 2-year overall survival rate of 63.8%, compared to 53.6% for those receiving ipilimumab alone, suggesting improved survival outcomes with the combination therapy.
However, the combination treatment was associated with a higher incidence of severe side effects, with 54% of patients experiencing grade 3-4 adverse events compared to 20% in the ipilimumab-only group, indicating a trade-off between efficacy and safety.
Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial.Hodi, FS., Chesney, J., Pavlick, AC., et al.[2022]

References

Successful Treatment of Multiple Metastatic Melanoma with Nivolumab, Ipilimumab plus Denosumab Combined Therapy. [2020]
A phase IB study of ipilimumab with peginterferon alfa-2b in patients with unresectable melanoma. [2021]
Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial. [2022]
A Multikinase and DNA-PK Inhibitor Combination Immunomodulates Melanomas, Suppresses Tumor Progression, and Enhances Immunotherapies. [2018]
Vemurafenib for the treatment of melanoma. [2018]
Full Spectrum: Efficacy and Toxicity of Immunotherapy in Metastatic Melanoma [2019]
Frequency, Treatment and Outcome of Immune-Related Toxicities in Patients with Immune-Checkpoint Inhibitors for Advanced Melanoma: Results from an Institutional Database Analysis. [2021]
CTLA-4 blockade with ipilimumab: biology, safety, efficacy, and future considerations. [2022]
Combined Therapy with Anti-PD1 and BRAF and/or MEK Inhibitor for Advanced Melanoma: A Multicenter Cohort Study. [2020]
Ipilimumab for advanced melanoma: a pharmacologic perspective. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. [2023]
Short-term CTLA-4 blockade directly followed by PD-1 blockade in advanced melanoma patients: a single-center experience. [2020]
Combined effect of ipilimumab and nivolumab improves oncology endpoints in metastatic melanoma patients. [2023]
Re-induction ipilimumab following acquired resistance to combination ipilimumab and anti-PD-1 therapy. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security