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Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors

Study acronym: KEYNOTE-603
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 20 sitesv31
  2. Enrollment target: estimated 242 to confirmed 161
    • Study sites: 17 to 20
    • Primary and study completion dates: Aug 1, 2027 to Nov 21, 2027
    v30
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 34 to 17
    • Eligibility criteria expanded, about 13 words
    v29
  4. Primary and study completion dates: Jun 30, 2025 to Aug 1, 2027v28
  5. Study sites: 31 to 34v27
Show 25 earlier versionsHide 25 earlier versions
  1. Re-verified, no change to tracked fieldsv26
  2. Study sites: 28 to 31v25
  3. Study sites: 21 to 28v24
  4. Study sites: 16 to 21v23
  5. Study sites: 13 to 16v22
  6. Study sites: 11 to 13v21
  7. Study sites: 10 to 11v20
  8. Site details revised at 1 of 10 sitesv19
  9. Site details revised at 3 of 10 sitesv18
  10. Trial status: Active, Not Recruiting to Recruitingv17 Show 8 more changesShow less
    • Enrollment target: 108 to 242
    • Interventions: Pembrolizumab (Biological), mRNA-4157 (Biological) to Pembrolizumab (Biological), SoC Treatment (Biological), mRNA-4157 (Biological)
    • Eligibility criteria shortened, about 355 words
    • Secondary endpoints: 6 to 8
    • Study description expanded, about 66 words
    • Site details revised at 10 of 10 sites
    • Study title shortened, about 9 words
    • Study arms: 4 to 8
  11. Re-verified, no change to tracked fieldsv16
  12. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 143 to confirmed 108
    • Site details revised at 10 of 10 sites
    v15
  13. Site contacts updated at 9 of 10 sitesv14
  14. Primary and study completion dates: Jun 30, 2022 to Jun 30, 2025
    • Enrollment target: 142 to 143
    v13
  15. Re-verified, no change to tracked fieldsv12
  16. Study sites: 7 to 10v11
  17. Site details revised at 1 of 7 sitesv10
  18. Site contacts updated at 1 of 7 sitesv9
  19. Re-verified, no change to tracked fieldsv8
  20. Enrollment target: 90 to 142v7 Show 7 more changesShow less
    • Primary completion date: Dec 2020 to Jun 30, 2022
    • Primary endpoints: 2 to 1
    • Study completion date: Jun 2022 to Jun 30, 2022
    • Eligibility criteria expanded, about 48 words
    • Secondary endpoints: 10 to 6
    • Study description expanded, about 102 words
    • Study title revised
  21. Re-verified, no change to tracked fieldsv6
  22. Primary completion date: Sep 2019 to Dec 2020
    • Study sites: 6 to 7
    • Study completion date: Jun 2021 to Jun 2022
    • Study arms: 3 to 4
    v5
  23. Study completion date: Mar 2020 to Jun 2021
    • Eligibility criteria expanded, about 235 words
    • Secondary endpoints revised (10)
    v4
  24. Site details revised at 2 of 6 sitesv3
  25. Site details revised at 1 of 6 sitesv2
  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.
Moderna
49 trials monitored
See 3 trials at risk
The purpose of this study is to assess the safety, tolerability, and immunogenicity of mRNA-4157 alone and in combination in participants with solid tumors.
Trial Details
NCT Number NCT03313778
Lead Sponsor ModernaTX, Inc.
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Solid Tumors
Enrollment 161 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov