Trial Title:
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma
NCT ID:
NCT06246916
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Nivolumab
Cemiplimab
Relatlimab
Conditions: Keywords:
Unresectable Melanoma
Metastatic Melanoma
Advanced Melanoma
Stage III
Stage IV
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
fianlimab
Description:
Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab
Arm group label:
fianlimab+cemiplimab
Other name:
REGN3767
Intervention type:
Drug
Intervention name:
cemiplimab
Description:
IV administration Q3W in combination with fianlimab
Arm group label:
fianlimab+cemiplimab
Other name:
REGN2810
Other name:
LIBTAYO®
Intervention type:
Drug
Intervention name:
relatlimab+nivolumab
Description:
IV administration every 4 weeks (Q4W)
Arm group label:
relatlimab+nivolumab
Other name:
Opdualag™
Summary:
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)
Criteria for 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 melanoma as described in the protocol.
3. Measurable disease per RECIST version 1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
5. Adequate bone marrow, hepatic, and kidney function.
Key Exclusion Criteria:
Medical Conditions:
1. Uveal, acral or mucosal melanoma.
2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required
systemic treatment with immunosuppressive agents as described in the protocol.
3. 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 cancer-related immunodeficiency
(such as immunodeficiency treated with gamma globulin and without chronic or
recurrent infection) is allowed.
4. Unknown v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status
as described in the protocol.
Prior/Concomitant Therapy:
5. Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in
the protocol
6. Systemic immune suppression as described in the protocol.
Other Comorbidities:
7. Participants with a history of myocarditis.
8. Troponin T (TnT) or troponin I (TnI) >2x institutional upper limit of normal (ULN).
9. Active or untreated brain metastases or spinal cord compression as described in the
protocol.
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCHealth
Address:
City:
Fort Collins
Zip:
80528
Country:
United States
Status:
Recruiting
Facility:
Name:
Clermont Oncology Center
Address:
City:
Clermont
Zip:
34711
Country:
United States
Status:
Recruiting
Facility:
Name:
Boca Raton Clinical Research (BRCR) Global
Address:
City:
Plantation
Zip:
33322
Country:
United States
Status:
Recruiting
Facility:
Name:
John B. Amos Cancer Center
Address:
City:
Columbus
Zip:
31904
Country:
United States
Status:
Recruiting
Facility:
Name:
Illinois CancerCare
Address:
City:
Peoria
Zip:
61615
Country:
United States
Status:
Recruiting
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
Allina Health Cancer Institute
Address:
City:
Minneapolis
Zip:
55407
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Hematology West, P.C. dba Nebraska Cancer Specialists
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Southwest
Address:
City:
Las Vegas
Zip:
89148
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Recruiting
Facility:
Name:
New York Oncology Hematology
Address:
City:
Albany
Zip:
12206
Country:
United States
Status:
Recruiting
Facility:
Name:
Kaiser Foundation Hospitals
Address:
City:
Portland
Zip:
97227
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Tennessee Medical Center
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center
Address:
City:
Tyler
Zip:
75701
Country:
United States
Status:
Recruiting
Facility:
Name:
West Virginia University (Please Use)
Address:
City:
Morgantown
Zip:
26506
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Wisconsin Carbone Cancer Center
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Start date:
September 9, 2024
Completion date:
June 26, 2033
Lead sponsor:
Agency:
Regeneron Pharmaceuticals
Agency class:
Industry
Source:
Regeneron Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06246916
