Neoadjuvant Chemoradiotherapy With Sequential Ipilimumab and Nivolumab in Rectal Cancer

Sponsor
Johannes Laengle, MD, PhD
Study ID
NCT04124601
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Chemoradiotherapy — RADIATION
    Capecitabine tablet with fractionated radiotherapy
  • Ipilimumab — DRUG
    Infusion
  • Nivolumab — DRUG
    Infusion

Study Details

This prospective randomized, open-label, multicenter, phase II clinical trial investigates the safety and tolerability of standard neoadjuvant chemoradiotherapy (CRT) with sequential ipilimumab and nivolumab in rectal cancer.

Key Dates

Start date
Jun 1, 2020
Status verified
Apr 2024
Primary completion
Mar 15, 2024
Completion
Mar 15, 2024

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Neoadjuvant Chemoradiotherapy
    Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days)
  • Experimental: Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab
    Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days) with sequential Ipilimumab (1 mg/kg IV on day 7) and Nivolumab (3 mg/kg IV on day 14, 28 and 42)

Primary Outcome Measure

Incidence of treatment-emergent adverse events (safety and tolerability) [ Time Frame: 20 weeks ]

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