Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Record History

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  1. Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description shortened, about 28 words
    v36
  2. Study description expanded, about 2 wordsv35
  3. Primary completion date: Apr 29, 2025 to Oct 30, 2026
    • Study completion date: Nov 30, 2026 to Oct 30, 2026
    v34
  4. Primary completion date changed from estimate of Apr 30, 2025 to Apr 29, 2025v33
  5. Trial status: Recruiting to Active, Not Recruitingv32 Show 4 more changesShow less
    • Primary completion date: Mar 15, 2025 to Apr 30, 2025
    • Study completion date: Jul 15, 2026 to Nov 30, 2026
    • Site details revised at 46 of 46 sites
    • Study description shortened, about 4 words
Show 30 earlier versionsHide 30 earlier versions
  1. Re-verified, no change to tracked fieldsv31
  2. Study sites: 45 to 46v30
  3. Site contacts updated at 3 of 45 sitesv29
  4. Study sites: 43 to 45v28
  5. Study sites: 42 to 43
    • Eligibility criteria expanded, about 711 words
    • Study description revised
    v27
  6. Study sites: 41 to 42
    • Interventions: GAd-209-FSP high dose (Biological), GAd-209-FSP low dose (Biological), GAd20-209-FSP, RP2D (Biological), MVA-209-FSP high dose… to GAd-209-FSP high dose (Biological), GAd-209-FSP low dose (Biological), GAd20-209-FSP, RP2D (Biological), KEYTRUDA® (Drug), MVA-209-FSP high…
    • Collaborators expanded, about 5 words
    v26
  7. Study sites: 38 to 41
    • Interventions: GAd-209-FSP high dose (Biological), GAd-209-FSP low dose (Biological), GAd20-209-FSP, RP2D (Biological), MVA-209-FSP high dose… to GAd-209-FSP high dose (Biological), GAd-209-FSP low dose (Biological), GAd20-209-FSP, RP2D (Biological), MVA-209-FSP high dose…
    v25
  8. Study description expanded, about 2 wordsv24
  9. Study sites: 20 to 38
    • Eligibility criteria shortened, about 1,220 words
    • Study description expanded, about 107 words
    v23
  10. Study sites: 13 to 20v22
  11. Primary completion date: Jul 15, 2023 to Mar 15, 2025v21 Show 8 more changesShow less
    • Primary endpoints revised (3)
    • Enrollment target: 84 to 115
    • Study sites: 8 to 13
    • Study completion date: Jul 15, 2024 to Jul 15, 2026
    • Eligibility criteria expanded, about 728 words
    • Secondary endpoints revised (2)
    • Study description expanded, about 65 words
    • Study arms: 3 to 4
  12. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 7 to 8
    v20
  13. Phase: Phase 1 to Phase 1/2v19
  14. Primary completion date: May 31, 2022 to Jul 15, 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jul 31, 2023 to Jul 15, 2024
    • Site details revised at 7 of 7 sites
    v18
  15. Trial status: Active, Not Recruiting to Recruitingv17 Show 7 more changesShow less
    • Enrollment target: 34 to 84
    • Primary endpoints: 2 to 3
    • Interventions: GAd-209-FSP high dose (Biological), GAd-209-FSP low dose (Biological), MVA-209-FSP high dose (Biological), MVA-209-FSP low dose (Biological) to GAd-209-FSP high dose (Biological), GAd-209-FSP low dose (Biological), GAd20-209-FSP, RP2D (Biological), MVA-209-FSP high dose…
    • Eligibility criteria expanded, about 997 words
    • Secondary endpoints: 1 to 2
    • Study description shortened, about 15 words
    • Site details revised at 7 of 7 sites
  16. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 9 to 7
    • Primary completion date: May 3, 2023 to May 31, 2022
    • Study completion date: May 3, 2023 to Jul 31, 2023
    v16
  17. Site contacts updated at 1 of 9 sitesv15
  18. Re-verified, no change to tracked fieldsv14
  19. Site details revised at 1 of 9 sitesv13
  20. Primary and study completion dates pushed to May 3, 2023
    • Site details revised at 1 of 9 sites
    v12
  21. Primary completion date: Jul 1, 2021 to Dec 30, 2021
    • Study completion date: Jan 1, 2023 to Apr 1, 2023
    • Site details revised at 1 of 9 sites
    • Study description expanded, about 5 words
    v11
  22. Study sites: 8 to 9v10
  23. Study sites: 6 to 8v9
  24. Study sites: 5 to 6v8
  25. Primary completion date: Apr 2021 to Jul 1, 2021
    • Study completion date: Sep 2022 to Jan 1, 2023
    • Eligibility criteria shortened, about 8 words
    • Study description expanded, about 8 words
    v7
  26. Study sites: 3 to 5v6
  27. Study sites: 2 to 3v5
  28. Study sites: 1 to 2v4
  29. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  30. Primary endpoints: 8 to 2
    • Start date: Sep 2019 to Oct 21, 2019
    • Eligibility criteria expanded, about 55 words
    • Study description expanded, about 3 words
    v2
  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.
Ref: Protocol Version 9.1 05 December 2024. NOUS-209-01 is a multicenter, open-label, multiple cohorts, clinical study, designed to evaluate safety, tolerability, and immunogenicity, and to detect any preliminary evidence of anti-tumor activity of Nous-209 genetic polyvalent vaccine plus pembrolizumab combination therapy in adult subjects with unresectable or metastatic deficient mismatch repair (dMMR) or MSI-H CRC, gastric, or gastro-esophageal junction (G-E junction) tumors. Nous-209 is based on a heterologous prime/boost regimen composed of the Great Ape Adenovirus GAd20-209-FSP used for priming and Modified Vaccinia virus Ankara MVA-209-FSP used for boosting. The Phase I portion of the study is a first-in-human (FIH) clinical study with a primary objective to elucidate the safety and tolerability of Nous-209 in addition to establishing the recommended Phase 2 dose (RP2D), whereas the Phase II was introduced to assess efficacy as the primary objective.
Trial Details
NCT Number NCT04041310
Lead Sponsor Nouscom SRL
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Solid Tumor, Adult
Related terms Neoplasms, Stomach Neoplasms
Enrollment 115 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov