Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO

Sponsor
The Netherlands Cancer Institute
Study ID
NCT03815890
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    2 courses 240 mg flat dose
  • Ipilimumab — DRUG
    single dose ipilimumab (1mg/kg) at day 1
  • Ipilimumab — DRUG
    two courses ipilimumab (1mg/kg) at day 1 and 21

Study Details

To determine whether short-term pre-operative nivolumab either as monotherapy or in combination with low dose doxorubicin or novel IO combinations can induce immune activation in early BC.

Key Dates

Start date
Oct 4, 2019
Status verified
May 2024
Primary completion
Jan 1, 2031
Completion
Jan 1, 2033

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1A; LumB
    Nivolumab
  • Experimental: 1B; TNBC
    Nivolumab
  • Experimental: 2A; LUMB
    Nivolumab and ipilimumab
  • Experimental: 2B; TNBC
    Nivolumab and ipilimumab
  • Experimental: 3B; TNBC, High TIL
    Nivolumab and ipilimumab

Primary Outcome Measure

Pathological complete response rate per cohort, [ Time Frame: up to 3 weeks after surgery, an average of 6 months ]

Central Contacts

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