GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Primary completion moved earlier from Feb 2028 to Jul 2027
    • Study completion moved earlier from Feb 2030 to Jul 2027
  2. Lead sponsor: Providence Health & Services to Providence Health & Services Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 12 participants (planned 92)
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 2 of 6 entries
    • Site details revised
  3. 3 versions Re-verified since Apr 5, 2024, no change to tracked fieldsv6-v8
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2024 to Feb 29, 2024
    • Site details revised
    v5
  5. Start date: Dec 2023 to Feb 2024
    • Primary completion date: Dec 2028 to Feb 2028
    • Study completion date: Dec 2030 to Feb 2030
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Sep 2023 to Dec 2023
    • Primary completion date: Sep 2028 to Dec 2028
    • Study completion date: Sep 2030 to Dec 2030
    v3
  2. Primary completion date: Aug 2028 to Sep 2028v2 Show 4 more changesShow less
    • Study completion date: Aug 2030 to Sep 2030
    • Start date: Aug 2023 to Sep 2023
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study description expanded, about 4 words
  1. Study First Submitted
  • 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 purpose of this study is to determine the objective response of GB1211 and pembrolizumab versus pembrolizumab and placebo in patients with advance metastatic melanoma or head and neck squamous cell carcinoma.
Trial Details
NCT Number NCT05913388
Lead Sponsor Providence Health & Services
Collaborators: Providence Cancer Center, Providence Cancer Center, Earle A. Chiles Research Institute, Galecto Biotech AB
Conditions
(from sponsor)		 Metastatic Melanoma, Head and Neck Squamous Cell Carcinoma
Related terms Melanoma, Squamous Cell Carcinoma of Head and Neck
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov