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NCT06848088

A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

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Record History

All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 10, 2029 to Oct 9, 2030 Show 4 more changesShow less
    • Eligibility criteria revised
    • Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Final enrollment: 28 participants (planned 48)
    • Site details revised at 2 of 11 sites
  2. Study sites: 9 to 11v7
  3. Study sites: 8 to 9v6
  4. Study sites: 6 to 8v5
  5. Study sites: 3 to 6v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 2 to 3v3
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Enrollment target: 98 to 48
    • Study sites: 0 to 2
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613
Timeframe: Up to 4 years

Secondary (9)

Progressive-Free Survival (PFS)
Objective Response Rate (ORR)
Duration of Response (DOR)
Disease Control Rate (DCR)
Incidence of Serious Adverse Events (SAEs)
Show 4 moreShow less
Severity of SAEs
Incidence of treatment-related AEs
Severity of treatment-related AEs
Incidence of anti-cancer therapies received since end of treatment with fianlimab and cemiplimab in study R3767-ONC-1613

Arms and interventions

With Disease Progression at EnrollmentOther
No Progressive Disease at EnrollmentOther

Drugs: Fianlimab+cemiplimab

Sites

11 sites in 2 countries

United States 10, Ireland 1