At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 80 target
Drug / intervention
Nivolumab +2 moredrug
Likely dose
Nivolumab 240 mgfrom record
Key inclusion· 14
- ✓Female, 18 years or older
- ✓WHO performance status 0 or 1
- ✓Resectable primary breast cancer stage I-III
- ✓Tumor at least 10 mm (minimum cT1c) by MRI
Key exclusion· 6
- ✕Evidence or suspicion of metastatic disease
- ✕Concurrent contralateral or ipsilateral second primary infiltrating breast cancer
- ✕Other malignancy except carcinoma in situ and basal-cell/squamous carcinoma of skin unless treated ≥5 years ago with curative intent without chemotherapy or radiotherapy
- ✕Previous radiation therapy or chemotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pre-operative Phase II Trial for Breast Cancer With Nivolumab in Combination With Novel IO (BELLINI Trial)
In Brief
A Phase 2 clinical trial evaluating Nivolumab and Ipilimumab for Breast Cancer. Currently recruiting, targeting 80 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesNetherlands
CollaboratorsBristol-Myers Squibb
Timeline
Phase 2Recruiting
201920202021202220232024202520262027202820292030203120322033
First PostedJan 2019
Enrollment StartOct 2019
TodayJul 2026
Primary CompletionJan 2031
Study CompletionJan 2033
First PostedJan 24, 2019
Enrollment StartOct 4, 2019
Primary CompletionJan 1, 2031
Study CompletionJan 1, 2033
TodayJul 2, 2026
Enrollment to primary: 11.2 yearsPosted 7.4 years agoPrimary completion in 4.5 years
Interventions
Nivolumabdrug
2 courses 240 mg flat dose
Ipilimumabdrug
single dose ipilimumab (1mg/kg) at day 1
Ipilimumabdrug
two courses ipilimumab (1mg/kg) at day 1 and 21