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Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 8, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Eligibility criteria shortened, about 7 words Secondary endpoints: details revised at 1 of 12 entries · Study description expanded, about 1 wordv7 Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 12 entries
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria revisedv6 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv5
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jul 2024 to Jun 21, 2024v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2024 to Jun 21, 2024
  5. Start date: Apr 2024 to Jul 2024 Primary completion date: Jun 2026 to Sep 2026 · Completion date: Apr 2036 to Jul 2036v3 Show 2 more changesShow less
    • Primary completion date: Jun 2026 to Sep 2026
    • Completion date: Apr 2036 to Jul 2036
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 (LAG-3) immune checkpoint pathways in a cohort of treatment-naïve, resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate (pCR) and recurrence-free survival.
Trial Details
NCT Number NCT06288191
Lead Sponsor Melanoma Institute Australia
Collaborators: Bristol-Myers Squibb
Conditions Cutaneous Squamous Cell Carcinoma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov