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Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Dec 31, 2026 → Jun 30, 2027
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 202 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 31, 2026 to Jun 30, 2027 Site details revised at 20 of 213 sites Show 1 more changeShow less
    • Site details revised at 20 of 213 sites
  2. Re-verified, no change to tracked fieldsv201
  3. Study sites: 214 to 213v200
  4. Study sites revised (214)v199 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 215 to 214v198
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (215)v197 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 216 to 215v196
  3. 31 versions Re-verified since Feb 26, 2026, no change to tracked fieldsv165-v195
  4. Study sites revised (216)v164 See this version in full on ClinicalTrials.gov ↗
  5. 3 versions Re-verified since Jul 16, 2025, no change to tracked fieldsv161-v163
  6. Study sites revised (216)v160 See this version in full on ClinicalTrials.gov ↗
  7. Study sites revised (216)v159 See this version in full on ClinicalTrials.gov ↗
  8. Study sites revised (216)v158 See this version in full on ClinicalTrials.gov ↗
  9. Study Status, Contacts/Locationsv157
  10. Re-verified, no change to tracked fieldsv156
  11. Trial status: Suspended to Active, Not Recruitingv155
  12. 2 versions Re-verified since Dec 17, 2024, no change to tracked fieldsv153-v154
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase II trial investigates the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may kill more cancer cells.
Trial Details
NCT Number NCT04751370
Lead Sponsor National Cancer Institute (NCI)
Conditions Locally Advanced Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov