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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)

StatusRecruiting
PhasePhase 3
Started2024-09-09
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
Study Status, Contacts/Locations v29
Study sites110→111
2026-07-22
Study Status, Contacts/Locations v28
Study sitesdetails revised at 3 of 110 sites
2026-07-08
Study Status, Contacts/Locations v27
Study sitesdetails revised at 2 of 110 sites
2026-06-17
Study Status, Contacts/Locations v26
Study sites109→110
2026-05-04
Study Status, Contacts/Locations v25
Study sites108→109
Show 24 earlier versions
2026-02-18
Study Status, Contacts/Locations v24
Study sites101→108
2026-01-06
Study Status, Contacts/Locations v23
Study sitesdetails revised at 2 of 101 sites
2025-11-17
Study Status, Contacts/Locations v22
Study sitesdetails revised at 3 of 101 sites
2025-11-05
Study Status, Contacts/Locations v21
Study sitesdetails revised at 3 of 101 sites
2025-10-09
Study Status, Contacts/Locations v20
Study sitesdetails revised at 2 of 101 sites
2025-09-05
Study Status, Contacts/Locations v19
Study sites99→101
2025-08-06
Study Status, Contacts/Locations v18
Study sites96→99
2025-07-25
Study Status, Contacts/Locations v17
Study sites84→96
2025-07-09
Study Status, Contacts/Locations v16
Study sites81→84
2025-06-18
Study Status, Contacts/Locations v15
Study sites76→81
2025-05-08
Study Identification, Study Status, Eligibility, Contacts/Locations v14
Completion date2033-06-26→2033-07-10
Study sites56→76
Eligibility criteria+45 characters
[...] 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 Exclusion Criteria: Medical Conditions: Uveal, acral or [...] lin and without chronic or recurrent infection) is allowed. Unknown v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status as described in the protocol. Prior/Concomitant Therapy: Prior immune checkpoint inhibitor [...]
Study title+23 characters
[...] s in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
2025-03-12
Study Status, Contacts/Locations v13
Study sites43→56
2025-02-07
Study Status, Contacts/Locations v12
Study sites28→43
2025-01-21
Study Status, Contacts/Locations v11
Study sites27→28
2025-01-06
Study Status, Contacts/Locations, IPDSharing v10
Study sites22→27
2024-12-23
Study Status, References v9
2024-12-20
Study Status, Contacts/Locations v8
Study sites17→22
2024-11-25
Study Status, Contacts/Locations v7
Study sites16→17
2024-11-05
Study Status, Contacts/Locations v6
Study sites12→16
2024-10-23
Study Status, Contacts/Locations v5
Study sites9→12
2024-10-08
Study Status, Contacts/Locations v4
Study sites7→9
2024-09-26
Study Status, Contacts/Locations v3
Start dateestimated 2024-08-19→confirmed 2024-09-09
Study sites1→7
2024-08-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2024-04-30
Study Status, Eligibility v1
Primary completion date2027-01-07→2027-03-22
Completion date2033-04-14→2033-06-26
Start date2024-06-07→2024-08-19
Eligibility criteria+97 characters
[...] us as described in the protocol. Prior/Concomitant Therapy: Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol Systemic immune suppression as described in the protocol. Ot [...]
2024-01-30
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
Melanoma
1,020 trials monitored
See 45 trials at risk
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)
Trial Details
NCT Number NCT06246916
Lead Sponsor Regeneron Pharmaceuticals
Conditions Melanoma
Enrollment 560 participants
Start Date 2024-09-09
Primary Completion 2027-03-22 (estimated)
Study Completion 2033-07-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-25