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Immunotherapy in Patients With Early dMMR Rectal Cancer

Study acronym: RESET-R
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Feb 2025 to Jul 2027
    • Study sites: 1 to 5
    • Study completion date: Feb 2027 to Feb 2052
    • Secondary endpoints revised (7)
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2023 to Feb 1, 2023
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this investigator-initiated, multicenter phase II trial is to evaluate the efficacy and tolerability of nivolumab and ipilimumab in patients with stage 1-3 MSI/dMMR rectal cancer. The primary objective is: Number of patients with complete clinical response after one or two cycles of immunotherapy. Patients will be treated with 1 or 2 cycles of combination immunotherapy: Cycle 1: Nivolumab 3 mg/kg days 1 and 15 \& ipilimumab 1 mg/kg day 1 Cycle 2: Nivolumab 3 mg/kg days 50 and 65 \& ipilimumab 1 mg/kg day 50
Trial Details
NCT Number NCT05732389
Lead Sponsor Odense University Hospital
Collaborators: Rigshospitalet, Denmark, Zealand University Hospital, Aalborg University Hospital, Aarhus University Hospital, Bispebjerg Hospital, Herlev and Gentofte Hospital, Vejle Hospital
Conditions
(from sponsor)		 Cancer of Rectum
Related terms Rectal Neoplasms
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov