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AZUR-4NCT06567782

A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 9 versions: 9 with changes below. See every version on ClinicalTrials.gov ↗

  1. Start date: Feb 17, 2025 to Feb 18, 2025
    • Site details revised at 2 of 33 sites
    v9
  2. Study sites: 32 to 33v8
  3. Study sites: 31 to 32v7
  4. Study sites: 30 to 31v6
  5. Study sites: 21 to 30
    • Primary completion date: Nov 13, 2026 to Nov 23, 2026
    • Study completion date: Oct 24, 2028 to Oct 26, 2028
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 12 to 21
    • Primary completion date: Jul 6, 2026 to Nov 13, 2026
    • Study completion date: Jun 15, 2028 to Oct 24, 2028
    v4
  2. Study sites: 1 to 12v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Primary completion date: Sep 7, 2028 to Jul 6, 2026
    • Primary endpoints revised (2)
    • Eligibility criteria expanded, about 2 words
    • Study sites: 15 to 1
    • Study completion date: Sep 7, 2028 to Jun 15, 2028
    • Start date changed from estimate of Dec 5, 2024 to Feb 17, 2025
    • Secondary endpoints: details revised at 2 of 5 entries
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Major pathological response (mPR) rate
Timeframe: Up to approximately 18 weeks
Number of participants with adverse events (AEs), serious adverse events (SAEs), immune-mediated adverse events (imAEs), and AEs leading to death or discontinuation of study intervention
Timeframe: Up to approximately 105 weeks

Secondary (5)

Percentage of participants for whom primary tumour resection is not excluded
Complete pathologic response (cPR) rate
Major pathological response excluding cPR rate
Partial pathologic response rate
Negligible pathologic response rate

Arms and interventions

Dostarlimab plus CAPEOXExperimental

Participants will receive dostarlimab plus CAPEOX (chemotherapy).

CAPEOXActive comparator

Participants will receive CAPEOX (chemotherapy).

Biologicals: Dostarlimab

Drugs: CAPEOX

Sites

33 sites in 6 countries

Belgium 11, Spain 9, Japan 4, United Kingdom 4, Italy 3, Switzerland 2