A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

Study acronym: AZUR-1
StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. 2 versions Re-verified since Jan 7, 2026, no change to tracked fieldsv9-v10
  2. Eligibility criteria revised
    • Secondary endpoints revised (20)
    v8
  3. Study sites: 56 to 42v7
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 150 to confirmed 154
    • Study sites: 62 to 56
    v6
  5. Site details revised at 44 of 62 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 61 to 62v4
  2. Enrollment target: 100 to 150v3 Show 6 more changesShow less
    • Primary completion date: Nov 25, 2025 to Nov 2, 2026
    • Study sites: 3 to 61
    • Study completion date: Oct 5, 2029 to Oct 11, 2029
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: 18 to 20
    • Study title shortened, about 7 words
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Mar 9, 2023 to Apr 3, 2023
    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 investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following dostarlimab treatment will undergo non-operative management (NOM), including close surveillance for recurrent disease. The goal of the study is to determine if Dostarlimab therapy alone is an effective treatment that can allow participants to avoid chemotherapy, radiation, and surgery.
Trial Details
NCT Number NCT05723562
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Neoplasms, Rectal
Related terms Rectal Neoplasms
Enrollment 154 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov