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New treatment option for Melanoma
Official title 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)
ClinicalTrials.gov ID: NCT06246916
What this study is testing
What is fianlimab?
fianlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melanoma.
Also referred to as REGN3767.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC)...
- Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
- Measurable disease per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
- Adequate bone marrow, hepatic, and kidney function
You likely can't join if
- Medical Conditions:
- Uveal, acral or mucosal melanoma.
- Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in...
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of...
- Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
- Systemic immune suppression as described in the protocol. Other Comorbidities:
See the full eligibility criteria
- Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
- Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
- Measurable disease per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
- Adequate bone marrow, hepatic, and kidney function
- Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol Key
- Medical Conditions:
- Uveal, acral or mucosal melanoma.
- Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild...
- Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
- Systemic immune suppression as described in the protocol. Other Comorbidities:
- Participants with a history of myocarditis.
- Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN).
- Active or untreated brain metastases or spinal cord compression as described in the protocol. Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Gilbert, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Fullerton, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Rancho Mirage, California, United States
- Redlands, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Santa Barbara, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- Englewood, Colorado, United States
- Fort Collins, Colorado, United States
- New Haven, Connecticut, United States
- Clermont, Florida, United States
- Jacksonville, Florida, United States
+ 74 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Gilbert, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Fullerton, California, United States; Los Alamitos, California, United States and 88 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.