Fianlimab and Cemiplimab for Advanced Melanoma
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Recruiting
Phase 3
Interventional Study
Melanoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 560 (estimated)
- Sponsor
- Regeneron Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults with advanced or metastatic melanoma. Participants will receive a combination of two experimental medications to find out how well they work and what side effects they may cause.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with unresectable stage III or IV melanoma.
- I have not received previous treatment for my melanoma.
- I have measurable disease based on certain medical guidelines.
- I have a good performance status and can carry out normal activities.
- I have adequate bone marrow, liver, and kidney function.
- I know my BRAF V600 mutation status or will provide a sample for testing.
You may not be able to join if
- I have uveal, acral, or mucosal melanoma.
- I have an ongoing or recent autoimmune disease requiring treatment.
- I have uncontrolled HIV, hepatitis B, or hepatitis C infection.
- I have had prior therapy with immune checkpoint inhibitors other than anti-PD1/PD-L1.
- I have a history of myocarditis.
- I have high troponin levels.
- I have active brain metastases or spinal cord compression.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About 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 compar…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
2. Participants must not have received prior systemic therapy for unresectable or metastatic melanom…
Contacts