Fianlimab + Cemiplimab for Melanoma

Recruiting at 1 trial location

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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is researching the long-term effects of a combination of experimental drugs called fianlimab and cemiplimab. The study is being conducted in patients with advanced skin cancer (melanoma) who had previously been treated with fianlimab and cemiplimab in the study called R3767-ONC-1613 (NCT03005782). The aim of the current study is to see how safe and effective the study drugs are in a long-term follow-up. No study drug will be given during this study. Cancer status will be monitored, in addition to routine care. The study is also collecting information about general health status, and other treatments that may have been received since participation in study R3767-ONC-1613 (NCT03005782).

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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