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Intrathecal Dual Checkpoint Inhibitor (PD-1 and CTLA-4) in Combination With Pemetrexed for Leptomeningeal Metastasis

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 2 changed
See other at-risk trials from Guangzhou Medical University

Record History

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  1. Enrollment increased: 34 → 39 participants
    • Eligibility criteria expanded, about 7 words
  2. Primary endpoint(s) modified
    • Study sites: 4 to 5
    • Study description expanded, about 3 words
    v6
  3. Primary completion date: Jun 1, 2026 to Dec 1, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 2 to 4
    • Study completion date: Jul 1, 2026 to Sep 1, 2027
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Lead sponsor: Zhenyu Pan to Guangzhou Medical Universityv3 Show 5 more changesShow less
    • Primary endpoints: 3 to 2
    • Start date changed from estimate of Sep 1, 2025 to Mar 17, 2025
    • Secondary endpoints shortened, about 13 words
    • Study description expanded, about 111 words
    • Study title expanded, about 6 words
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 1, 2025 to Sep 1, 2025
    • Study sites: 0 to 2
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase I/II study is to evaluate the recommended dose, safety, feasibility, and therapeutic response of intrathecal dual checkpoint inhibitor (targeting PD-1 and CTLA-4 with QL1706) in combination with pemetrexed in patients with leptomeningeal metastasis.
Trial Details
NCT Number NCT06809530
Lead Sponsor Guangzhou Medical University
Conditions
(from sponsor)		 Leptomeningeal Metastasis, Pemetrexed, PD-1 Inhibitor, CTLA4, Solid Tumors
Related terms Meningeal Carcinomatosis
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov