Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT05352672 : A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

12+Age Over 12

Skin<br/>CancersCancer LocationSkin
Cancers

Systemic therapy | SkinMelanoma (Skin)

Trial Overview Read MoreRead more

This phase III study is seeking to determine whether combination immunotherapy (fianlimab + cemiplimab) is more effective than another type of immunotherapy (pembrolizumab) in adolescents and adults with previously untreated, inoperable, locally advanced or metastatic melanoma.
 

This trial is treating patients with melanoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Commercial Sponsor

Regeneron Pharmaceuticals

Summary

This trial is recruiting people with unresectable Stage III and Stage IV (metastatic) melanoma who have not received prior systemic therapy for their advanced unresectable disease. Eligible participants will be randomly allocated to one of four experimental arms. In Experimental Arm A, participants will receive fianlimab and cemiplimab at dose level 1. In Experimental Arm A1, participants will receive fianlimab and cemiplimab at dose level 2. In Experimental Arm B, participants will receive pembrolizumab plus a placebo. In Experimental Arm C, participants will receive cemiplimab plus a placebo. All therapies will be administered via intravenous (IV) infusion.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Medical Oncology
Prahran
ACT Team
act-m@alfred.org.au

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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