Fianlimab + Cemiplimab for Melanoma

Enrolling by invitation at 5 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Regeneron Pharmaceuticals

Disqualifiers: Melanoma, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the long-term safety and effectiveness of two experimental drugs, fianlimab and cemiplimab, for individuals with advanced melanoma, a type of skin cancer. It focuses on those who have previously taken these drugs in an earlier study. Participants will not receive any new drugs during this trial; instead, researchers will monitor their cancer status and overall health over time. Suitable candidates have melanoma and were part of specific groups in the previous study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. Since no study drug will be given during this study, it's likely you can continue your usual medications, but you should confirm with the study team.

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

Research has shown that the combination of fianlimab and cemiplimab is generally safe, comparable to other treatments that enhance the immune system by blocking certain proteins. In earlier studies, this combination demonstrated a promising balance between benefits and risks for patients with advanced melanoma.

Although some side effects occurred, they resembled those seen with other immune-boosting cancer treatments. Overall, the safety profile appears acceptable, making this combination a potential option for individuals considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of fianlimab and cemiplimab for treating melanoma because it targets the immune system in a novel way. Unlike traditional treatments such as chemotherapy or single-agent immunotherapies like pembrolizumab and nivolumab, this combination uses both a PD-1 inhibitor (cemiplimab) and an LAG-3 inhibitor (fianlimab). The dual action aims to enhance the immune system’s ability to attack cancer cells more effectively by blocking two different pathways that tumors use to evade immune detection. This innovative approach has the potential to improve response rates and outcomes for patients with melanoma, offering hope for better control of the disease.

What evidence suggests that fianlimab and cemiplimab might be an effective treatment for melanoma?

Research has shown that using fianlimab and cemiplimab together may effectively treat advanced melanoma, a type of skin cancer. One study found that 61.2% of patients experienced their cancer shrinking or disappearing with this combination. The time before the cancer worsened was about 13.3 months, which is better than some treatments targeting the PD-1 protein alone. Another study found that this combination continued to work well over time, even for patients whose melanoma lacked certain proteins (LAG-3 or PD-L1). Overall, these findings suggest that fianlimab and cemiplimab together could be a strong option for treating advanced skin cancer. Participants in this trial will receive this combination therapy, regardless of their disease progression status at enrollment. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults who previously participated in specific cohorts (6, 15, or 16) of a melanoma study (R3767-ONC-1613). It's focused on those with advanced skin cancer and aims to monitor their long-term health after being treated with fianlimab and cemiplimab.

Inclusion Criteria

I was in cohorts 6, 15, or 16 of the R3767-ONC-1613 study for melanoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness of the study drugs, cancer status, and general health status

Long-term

Data Collection

Information about other treatments received since participation in the previous study is collected

What Are the Treatments Tested in This Trial?

Interventions

• Fianlimab+cemiplimab

Trial Overview The study isn't testing new treatments but is following up on the long-term safety and effectiveness of fianlimab and cemiplimab. Participants won't receive these drugs during this phase; instead, their cancer status and overall health will be monitored routinely.

How Is the Trial Designed?

Group I: With Disease Progression at Enrollment Experimental Treatment 1 Intervention

Group II: No Progressive Disease at Enrollment Experimental Treatment 1 Intervention

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

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38900987/

Phase I Study of Fianlimab, a Human Lymphocyte ... Conclusion: The current results show a promising benefit-risk profile of fianlimab/cemiplimab combination for patients with advanced melanoma, ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.02172

Phase I Study of Fianlimab, a Human Lymphocyte ... Fianlimab/cemiplimab combination showed improved efficacy (ORR, 61.2%; PFS, 13.3 months) versus anti–PD-1 monotherapy and apparently, ...

3. onclive.com onclive.com/view/fianlimab-cemiplimab-demonstrates-persistent-activity-in-advanced-melanoma-independent-of-lag-3-and-pd-l1-status

Fianlimab/Cemiplimab Demonstrates Persistent Activity in ... Fianlimab plus cemiplimab demonstrated persistent and significant clinical activity in patients with advanced melanoma.

4. curemelanoma.org curemelanoma.org/blog/clinical-trials-testing-combination-immunotherapy-for-high-risk-and-advanced-melanoma-regenerons-lag-3-program

Clinical Trials Testing Combination Immunotherapy for ... Results showed that 43% of patients who received the nivolumab + relatlimab combination responded to the treatment. The combination of nivolumab ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT409630

A phase 1 study of fianlimab (anti-LAG-3) in combination ... Conclusions: The combination of fianlimab and cemiplimab showed high activity in pts with advanced Mel and poor prognosis features at BL. The ORR and DCR ...

6. investor.regeneron.com investor.regeneron.com/news-releases/news-release-details/fianlimab-lag-3-inhibitor-combined-libtayor-cemiplimab

Fianlimab (LAG-3 Inhibitor) Combined with Libtayo® ... Our LAG-3 inhibitor fianlimab combined with Libtayo demonstrated greater than 60% response rates. Notably, the safety profile for this combination appears in ...