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Evaluating Ivonescimab as a Potential Treatment for Pleural Mesothelioma Patients Whose Cancer Has Returned After Previous Immunotherapy and Chemotherapy

Study acronym: Bi-MAPS
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 10, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 6 months later Mar 24, 2026 → Sep 30, 2026
See other at-risk trials from Intergroupe Francophone de Cancerologie Thoracique

Record History

  1. Primary completion pushed from Mar 24, 2026 to Sep 30, 2026 Study sites: 20 to 21 · Eligibility criteria expanded, about 189 wordsv5 Show 2 more changesShow less
    • Study sites: 20 to 21
    • Eligibility criteria expanded, about 189 words

    See this version in full on ClinicalTrials.gov ↗

  2. Site details revised at 14 of 20 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 9, 2025 to Jun 30, 2025 · Site details revised at 20 of 20 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Jun 9, 2025 to Jun 30, 2025
    • Site details revised at 20 of 20 sites
  4. Start date: Apr 1, 2025 to Jun 9, 2025v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Multicentre, open-label, single arm phase II study for patients with PM previously treated by immunotherapy and standard chemotherapy. 38 patients will be given second or third-line treatment with ivonescimab 20mg/kg every 3 weeks. An estimated 38 patients will be enrolled in approximately 20 centres. Patients will be treated for a maximum of 2 years, until disease progression, unacceptable toxicity, withdrawal of consent or another discontinuation criterion is met. The null hypothesis is disease control rate (DCR) at 12 weeks ≤ 30%. The alternative hypothesis is DCR ≥ 55% at 12 weeks.
Trial Details
NCT Number NCT06840834
Lead Sponsor Intergroupe Francophone de Cancerologie Thoracique
Collaborators: Summit Therapeutics
Conditions Pleural Mesotheliomas
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov