Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Oct 2026 → Oct 2027
See other at-risk trials from Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 2026 to Oct 2027
    • Eligibility criteria expanded, about 31 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 42 to confirmed 38
    • Site details revised at 2 of 2 sites
    v24
  3. Site contacts updated at 1 of 2 sitesv23
  4. Primary and study completion dates: Oct 2025 to Oct 2026v22
  5. Primary and study completion dates: Oct 2024 to Oct 2025v21
Show 19 earlier versionsHide 19 earlier versions
  1. Study sites: 1 to 2v20
  2. Primary and study completion dates: Oct 2023 to Oct 2024v19
  3. 3 versions Re-verified since Mar 6, 2023, no change to tracked fieldsv16-v18
  4. Collaborators: 1 to 2v15
  5. Interventions: Nivolumab (Drug), Nivolumab (Drug), Relatlimab (Drug), Relatlimab (Drug) to Nivolumab (Drug), Nivolumab (Drug), Nivolumab (Drug), Relatlimab (Drug), Relatlimab (Drug), Relatlimab (Drug)
    • Study arms: 2 to 3
    v14
  6. Site contact updatedv13
  7. Eligibility criteria expanded, about 2 wordsv12
  8. Site contact updatedv11
  9. Start date: Nov 14, 2018 to Nov 16, 2018v10
  10. Re-verified, no change to tracked fieldsv9
  11. Enrollment target: 21 to 42v8 Show 4 more changesShow less
    • Interventions: Nivolumab (Drug), Relatlimab (Drug) to Nivolumab (Drug), Nivolumab (Drug), Relatlimab (Drug), Relatlimab (Drug)
    • Site contact updated
    • Study arms: 1 to 2
    • Eligibility criteria expanded, about 1 word
  12. Primary and study completion dates: Oct 2022 to Oct 2023v7
  13. Site contact updatedv6
  14. Secondary endpoints: 8 to 1v5
  15. Start date: Nov 6, 2018 to Nov 14, 2018
    • Study title shortened, about 2 words
    v4
  16. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2018 to Nov 6, 2018
    • Site details revised
    v3
  17. Primary and study completion dates: Sep 2022 to Oct 2022
    • Start date: Sep 2018 to Oct 2018
    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.
The purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with microsatellite instability high (MSI-H) solid tumors refractory to prior PD-(L)1 therapy.
Trial Details
NCT Number NCT03607890
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Bristol-Myers Squibb, National Cancer Institute (NCI)
Conditions
(from sponsor)		 Refractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy, MSI-H Tumors
Related terms Microsatellite Instability, Turcot syndrome
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov