Fianlimab
DrugIntravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab
Other names: REGN3767
NCT Number: NCT06246916
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)
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Cross Cancer Institute, Edmonton, Alberta, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Medical Conditions:
Prior/Concomitant Therapy:
Other Comorbidities:
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab
Other names: REGN3767
IV administration Q3W in combination with fianlimab
Other names: REGN2810, LIBTAYO®
IV administration every 4 weeks (Q4W)
Other names: Opdualag™
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Grade ≥3 per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) including standard hematology, chemistry, urinalysis, and other lab tests
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Time frame: Up to 72 months
Contact information is provided by the study sponsor or research team.
Regeneron Pharmaceuticals
Industry
A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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