NCT03815890

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

Pre-operative Phase II Trial for Breast Cancer With Nivolumab in Combination With Novel IO (BELLINI Trial)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators aim to test the activity of nivolumab monotherapy in primary breast tumors in a pre-operative window of opportunity trial. As the data of the investigators generated in the TONIC trial (metastatic TNBC) indicate that low dose doxorubicin may 'prime' the tumor microenvironment (TME) resulting in higher response rates on nivolumab, in addition, cohorts for treatment with nivolumab plus low dose doxorubicin will be opened. Given the emerging data on other immunomodulatory strategies, this platform study allows opening additional cohorts for promising novel immune-oncology (IO) drugs for which a strong efficacy signal has been seen without drug safety issues. The investigators will study the TME and systemic host factors with specific emphasis on immunosuppressive processes that can potentially be targeted by novel IO agents to further optimize BC immunotherapy.

Conditions

• Breast Cancer

Interventions

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

Timeline

• Start date: 2019-10-04
• Primary completion: 2031-01-01
• Completion: 2033-01-01
• First posted: 2019-01-24
• Last updated: 2024-05-30

Locations

1 site across 1 country: Netherlands