560 Participants Needed

Fianlimab + Cemiplimab for Melanoma

Recruiting at 79 trial locations
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Regeneron Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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, it mentions that participants should not have received prior systemic therapy for melanoma and should not be on systemic immune suppression. It's best to discuss your current medications with the trial team.

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

Research shows that similar drugs like nivolumab, when combined with other treatments, have been effective in treating advanced melanoma by enhancing the body's immune response to fight cancer. This suggests that combining Fianlimab and Cemiplimab might also be effective in treating melanoma.12345

What safety data exists for Fianlimab + Cemiplimab treatment in humans?

The safety data for treatments similar to Fianlimab + Cemiplimab, such as other immune checkpoint inhibitors, show that they can cause immune-related side effects like skin rashes, fatigue, and inflammation in various body parts. These side effects are often manageable with medications like steroids, and some studies suggest that experiencing these side effects might be linked to better treatment outcomes.678910

What makes the drug Fianlimab + Cemiplimab unique for treating melanoma?

Fianlimab + Cemiplimab is unique because it combines two immune checkpoint inhibitors, which work by helping the immune system recognize and attack cancer cells more effectively. This combination aims to enhance the body's immune response against melanoma, potentially offering a novel approach compared to existing treatments that often use single agents or different combinations.13111213

What is the purpose of this trial?

This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children.The study is looking at several other research questions, including:* What side effects may happen from taking the study drugs.* How much study drug is in the blood at different times.* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)

Research Team

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

This trial is for adults with advanced or metastatic melanoma who haven't had systemic therapy for this condition. They should have a performance status indicating they can carry out light activity, and their major organs must be functioning well.

Inclusion Criteria

My blood, liver, and kidney tests are normal.
My melanoma is at an advanced stage and cannot be surgically removed.
I have not had systemic therapy for my advanced melanoma.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either fianlimab and cemiplimab or relatlimab and nivolumab to assess safety and effectiveness in treating melanoma

Up to 72 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of laboratory abnormalities

4-8 weeks

Treatment Details

Interventions

  • Cemiplimab
  • Fianlimab
  • Relatlimab+Nivolumab
Trial Overview The study compares the safety and effectiveness of two treatments: fianlimab combined with cemiplimab versus relatlimab plus nivolumab (Opdualag™). It also examines side effects, drug levels in blood over time, and potential immune responses to the drugs.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: fianlimab+cemiplimabExperimental Treatment2 Interventions
Randomized 1:1
Group II: relatlimab+nivolumabActive Control1 Intervention
Randomized 1:1

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?

Regeneron Pharmaceuticals

Lead 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]
Pembrolizumab and nivolumab are effective PD-1 inhibitors for treating metastatic melanoma, showing objective response rates of 26-38% and 31-40% respectively in patients who did not respond to previous treatments.
Both therapies have an acceptable safety profile, with most treatment-related side effects being mild (grade 1 or 2) and manageable, making them viable options for patients with treatment-refractory melanoma.
Pembrolizumab and nivolumab: PD-1 inhibitors for advanced melanoma.Ivashko, IN., Kolesar, JM.[2022]
Regorafenib and NU7441 were identified as promising therapies that can enhance T-cell immunotherapy for melanoma by modifying immunomodulatory proteins and increasing melanoma antigens, which may improve treatment outcomes.
In mouse models, regorafenib not only suppressed melanoma progression but also positively influenced T-cell behavior, leading to increased proliferation and cytokine production, suggesting a synergistic effect when combined with other immunotherapies.
A Multikinase and DNA-PK Inhibitor Combination Immunomodulates Melanomas, Suppresses Tumor Progression, and Enhances Immunotherapies.Tsai, AK., Khan, AY., Worgo, CE., et al.[2018]

References

Successful Treatment of Multiple Metastatic Melanoma with Nivolumab, Ipilimumab plus Denosumab Combined Therapy. [2020]
Pembrolizumab and nivolumab: PD-1 inhibitors for advanced melanoma. [2022]
A Multikinase and DNA-PK Inhibitor Combination Immunomodulates Melanomas, Suppresses Tumor Progression, and Enhances Immunotherapies. [2018]
Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design. [2021]
Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma. [2022]
Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data. [2022]
Frequency, Treatment and Outcome of Immune-Related Toxicities in Patients with Immune-Checkpoint Inhibitors for Advanced Melanoma: Results from an Institutional Database Analysis. [2021]
Association between immune-related adverse events and efficacy of PD-1 inhibitors in Chinese patients with advanced melanoma. [2021]
Full Spectrum: Efficacy and Toxicity of Immunotherapy in Metastatic Melanoma [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Influence of melanoma type on incidence and downstream implications of cutaneous immune-related adverse events in the setting of immune checkpoint inhibitor therapy. [2023]
Improving survival in patients with high-risk and metastatic melanoma: immunotherapy leads the way. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Clinical development of the anti-CTLA-4 antibody tremelimumab. [2021]
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