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NCT05608291

A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

StatusActive, Not Recruiting
PhasePhase 3
Primary completion (estimated)

At risk: Primary completion moved at least 5 months later.

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Record History

All 33 versions: 33 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 10 words
    • Primary completion pushed from Jul 27, 2026 to Jan 15, 2027
    • Secondary endpoints: details revised at 9 of 22 entries
    • Site details revised at 8 of 211 sites
  2. Primary completion date: May 16, 2028 to Jul 27, 2026
    • Study completion date: Feb 15, 2030 to Apr 3, 2030
    v32
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1530 to confirmed 1564
    • Study sites: 219 to 211
    v31
  4. Study sites: 213 to 219v30
  5. Study sites: 210 to 213v29
Show 27 earlier versionsHide 27 earlier versions
  1. Study sites: 207 to 210v28
  2. Study sites: 205 to 207v27
  3. Study sites: 201 to 205v26
  4. Study sites: 197 to 201v25
  5. Study sites: 196 to 197v24
  6. Study sites: 194 to 196v23
  7. Study Status, Referencesv22
  8. Study sites: 188 to 194v21
  9. Primary completion date: Feb 27, 2030 to May 16, 2028v20 Show 4 more changesShow less
    • Eligibility criteria expanded, about 3 words
    • Study sites: 163 to 188
    • Study completion date: Feb 27, 2030 to Feb 15, 2030
    • Secondary endpoints: 23 to 22
  10. Study sites: 140 to 163v19
  11. Study sites: 102 to 140v18
  12. Study sites: 95 to 102v17
  13. Study sites: 84 to 95v16
  14. Study sites: 77 to 84v15
  15. Study sites: 72 to 77v14
  16. Study sites: 64 to 72v13
  17. Study sites: 59 to 64v12
  18. Study sites: 54 to 59v11
  19. Study sites: 46 to 54v10
  20. Study sites: 31 to 46v9
  21. Study sites: 20 to 31v8
  22. Study sites: 12 to 20v7
  23. Study sites: 9 to 12v6
  24. Study sites: 6 to 9v5
  25. Study sites: 5 to 6v4
  26. Study sites: 1 to 5
    • Primary and study completion dates: Oct 11, 2029 to Feb 27, 2030
    • Start date changed from estimate of Jan 25, 2023 to Jan 16, 2023
    • Study title expanded, about 4 words
    v3
  27. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Relapse free survival (RSF)
Timeframe: Up to 5 Years

Secondary (22)

Distant metastasis-free survival (DMFS)
Overall survival (OS)
Occurrence of treatment-emergent adverse events (TEAEs)
Occurrence of immune-mediated EAEs (im-EAEs)
Occurrence of serious adverse events (SAEs)
Show 17 moreShow less
Occurrence of adverse events of special interest (AESIs)
Occurrence of TEAEs resulting in death
Occurrence of dose-limiting toxicity (DLT)
Occurrence of interruption or discontinuation of study drug(s) due to TEAE
Occurrence of laboratory abnormalities
Concentrations of fianlimab in serum over time
Concentrations of cemiplimab in serum over time
Concentration of finalimab anti-drug antibodies (ADA) and neutralizing antibodies
Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies
Patient report outcomes (PRO) for adults as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PRO for adults as measured by the European Quality of Life Dimension 5 (EQ-5D-5L)
PRO for adults as measured by the Functional Assessment of Cancer Therapy (FACT) - melanoma
PRO for adults as determined by the Patient Global Impressions Scale (PGIS)
PRO for adults as determined by the Patient Global Impressions of Change Scale (PGIC)
Time to global health status/quality of life deterioration per EORTC QLQ-C30
Time to physical functioning deterioration per EORTC QLQ-C30
Time to role functioning deterioration per EORTC QLQ-C30

Arms and interventions

Fianlimab HD + CemiplimabExperimental

Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab

Fianlimab LD + CemiplimabExperimental

Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab

PembrolizumabActive comparator

Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo

Drugs: Fianlimab, Cemiplimab, Pembrolizumab, Placebo

Sites

211 sites in 22 countries

United States 28, Germany 22, France 21, Brazil 18, Spain 16, Italy 14, Turkey (Türkiye) 11, Australia 10, United Kingdom 9, Romania 8, Georgia 7, Mexico 7, Argentina 6, Greece 5, Poland 5, Canada 4, Ireland 4, South Africa 4, Belgium 3, Chile 3, Czechia 3, Israel 3