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Neoadjuvant Regorafenib in Combination With Nivolumab and Short-course Radiotherapy in Stage II-III Rectal Cancer

Study acronym: REGINA
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv25
  2. Primary completion date: Jan 2026 to Dec 31, 2026 Trial status: Recruiting to Active, Not Recruiting · Study sites: 10 to 9 · Completion date: Dec 2030 to Dec 2032v24 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 10 to 9
    • Completion date: Dec 2030 to Dec 2032
  3. Site details revised at 3 of 10 sitesv23
  4. Primary completion date: Jan 2025 to Jan 2026 Completion date: Jan 2030 to Dec 2030 · Eligibility criteria shortened, about 4 wordsv22 Show 2 more changesShow less
    • Completion date: Jan 2030 to Dec 2030
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 2 of 10 sitesv21
Show 19 earlier versionsHide 19 earlier versions
  1. Site details revised at 2 of 10 sitesv20
  2. Site details revised at 1 of 10 sitesv19
  3. Site details revised at 1 of 10 sitesv18
  4. Trial status: Active, Not Recruiting to Recruiting Study sites: 12 to 10v17 Show 1 more changeShow less
    • Study sites: 12 to 10
  5. Re-verified, no change to tracked fieldsv16
  6. Trial status: Recruiting to Active, Not Recruiting Enrollment target: 60 to 72 · Study sites: 13 to 12 · Completion date: Sep 2029 to Jan 2030 · 3 morev15 Show 6 more changesShow less
    • Enrollment target: 60 to 72
    • Study sites: 13 to 12
    • Completion date: Sep 2029 to Jan 2030
    • Interventions: Nivolumab 10 MG/ML Intravenous Solution (Drug), Non-operative Management (Procedure), Radiotherapy (Radiation), Regorafenib 40 MG Oral… to Nivolumab 10 MG/ML Intravenous Solution (Drug), Non-operative Management (Procedure), Radiotherapy (Radiation), Regorafenib 30 MG Oral…
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: 8 to 7

    See this version in full on ClinicalTrials.gov ↗

  7. Primary completion date: Sep 2023 to Jan 2025 Completion date: Sep 2028 to Sep 2029v14 Show 1 more changeShow less
    • Completion date: Sep 2028 to Sep 2029
  8. Interventions: Nivolumab 10 MG/ML Intravenous Solution (Drug), Radiotherapy (Radiation), Regorafenib 40 MG Oral Tablet (Drug), Surgery (Procedure) to Nivolumab 10 MG/ML Intravenous Solution (Drug), Non-operative Management (Procedure), Radiotherapy (Radiation), Regorafenib 40 MG Oral… Secondary endpoints revised (8) · Study title shortened, about 1 wordv13 Show 2 more changesShow less
    • Secondary endpoints revised (8)
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 10 to 13v12
  10. Site details revised at 1 of 10 sitesv11
  11. Site details revised at 1 of 10 sitesv10
  12. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 6 to 60 · Site details revised at 10 of 10 sitesv9 Show 2 more changesShow less
    • Enrollment target: 6 to 60
    • Site details revised at 10 of 10 sites
  13. Re-verified, no change to tracked fieldsv8
  14. Study sites: 4 to 10v7
  15. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 60 to confirmed 6 · Eligibility criteria shortened, about 35 words · Secondary endpoints: 7 to 8 · 1 morev6 Show 4 more changesShow less
    • Enrollment target: estimated 60 to confirmed 6
    • Eligibility criteria shortened, about 35 words
    • Secondary endpoints: 7 to 8
    • Site details revised at 4 of 4 sites

    See this version in full on ClinicalTrials.gov ↗

  16. Study sites: 3 to 4v5
  17. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Apr 15, 2021 to Mar 25, 2021v4 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Apr 15, 2021 to Mar 25, 2021
  18. Start date: Feb 2021 to Apr 15, 2021v3
  19. Start date: Nov 2020 to Feb 2021v2
  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.
This is a multicenter, single-arm, phase II study of nivolumab in combination with regorafenib in subjects with locally-advanced rectal cancer who are eligible for a curative treatment including pre-operative SCRT and TME(or watch \& wait approach). The study is based on the Simon's two-stage design and a maximum of 60 subjects will be enrolled. In addition to the standard efficacy interim analysis according to the statistical design, a safety interim analysis will be performed on the first 6 subjects who have completed the study treatment to ensure safe continuation of the study investigation. Eligible subjects will be treated according to the following sequential treatment plan: * Induction treatment: This consists of treatment with nivolumab (240 mg intravenously, on day 1 and 15) and regorafenib (60 mg/day orally, from day 1 to 14) * Standard SCRT: This consists of 25 Gy delivered in 5 fractions (from day 22 to 26) * Consolidation treatment: This consists of treatment with nivolumab (240 mg intravenously, on day 29, 43 and 57) and regorafenib (60 mg/day orally, from day 29 to 49) * Surgery: Surgical resection will be performed according to the principles of TME (between day 74 and 87, i.e., between 7 to 8 weeks after completion of SCRT). As an alternative to surgery, subjects who achieve cCR can be offered a watch \& wait approach. * Adjuvant chemotherapy: Administration of adjuvant chemotherapy will be left to the discretion of the treating physician The study also includes translational procedures (i.e. collection of tumour biopsies, blood samples and stool samples at pre-specified time points) for exploratory molecular and immune contexture analyses. These are mandatory for all study subjects.
Trial Details
NCT Number NCT04503694
Lead Sponsor Jules Bordet Institute
Conditions Rectal Cancer Stage II, Rectal Cancer Stage III
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov