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Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 6, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv12
  2. Trial status: Terminated to Active, Not Recruiting
    • Primary and study completion dates: Jun 12, 2024 to Dec 31, 2025
    v11
  3. Trial status: Active, Not Recruiting to Terminated Sponsor's reason: toxicity - per sponsor
    • Primary and study completion dates changed from estimate of Dec 2025 to Jun 12, 2024
    v10
  4. Re-verified, no change to tracked fieldsv9
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 48 to confirmed 45
    • Site details revised at 2 of 2 sites
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Eligibility criteria expanded, about 21 wordsv7
  2. 2 versions Re-verified since Jun 23, 2020, no change to tracked fieldsv5-v6
  3. Collaborators expanded, about 2 wordsv4
  4. Study sites: 1 to 2v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2019 to Apr 9, 2019
    • Site details revised
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase II trial studies how well nivolumab works, with or without BMS986205, in treating patients with stage II-IV squamous cell cancer of the head and neck. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. BMS986205 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab with BMS986205 may work better than nivolumab alone in treating patients with squamous cell cancer of the head and neck.
Trial Details
NCT Number NCT03854032
Lead Sponsor Thomas Jefferson University
Collaborators: Bristol-Myers Squibb
Conditions
(from sponsor)		 Lip, Oral Cavity Squamous Cell Carcinoma, Pharynx, Larynx, Squamous Cell Carcinoma
Related terms Carcinoma, Squamous Cell, Laryngeal Diseases, Lymphoid Interstitial Pneumonia, Squamous Cell Carcinoma of Head and Neck
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov