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Pre-operative phase II trial for breast cancer with nivolumab in combination with novel IO (BELLINI trial)
EU CTIS ID: 2024-515080-54-00
What this study is testing
To determine whether short-term pre-operative nivolumab either as monotherapy or in combination with ipilimumab or relatlimab or novel IO combinations can induce pathological complete response
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed written informed consent
- 18 years or older at moment of inclusion
- Female gender
- WHO performance status 0 or 1
- Resectable primary breast cancer stage I-III. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan (cohort 3B, 4B ,5B and 2A and 3A: PET-CT mandatory).
- The tumors must be: >5 mm (minimum cT1b) as determined by MRI. TNBC (all cohorts B) defined as ER<10%, HER2-negative. Luminal B (cohort 1A) defined as ER≥10%, HER2- negative with either Ki67≥20% or PR ≤20% OR grade 3 AND TIL ≥1%. High-risk ER (cohort 2A and 3A) cT3-4N0 OR clinically node positive AND grade 3 OR grade 2 with ER levels of 50% or lower or TIL≥1%. For cohort 3B: N0 status, TNBC and TIL ≥50%. For cohort 4B: N0 status, TNBC and TIL 30-49%. For cohort 5B: N0 status, TNBC and TIL ≥50%.
You likely can't join if
- evidence or suspicion of metastatic disease. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures
- other prior invasive malignancy 1) in the breast or 2) localized in the near proximity of the breast, that was treated with radiotherapy at the localization of the new breast tumor
- occult breast cancer
- previous anti-cancer hormone therapy or chemotherapy
- prior treatment with checkpoint inhibitors (including anti-PD1, -PD-L1, -CTLA-4, -LAG3)
- concurrent anti-cancer treatment, neoadjuvant therapy or another investigational drug (except for neoadjuvant chemotherapy in cohort 2A / 3A)
See the full eligibility criteria
- Signed written informed consent
- 18 years or older at moment of inclusion
- Female gender
- WHO performance status 0 or 1
- Resectable primary breast cancer stage I-III. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan (cohort 3B, 4B ,5B and 2A and 3A: PET-CT mandatory).
- The tumors must be: >5 mm (minimum cT1b) as determined by MRI. TNBC (all cohorts B) defined as ER<10%, HER2-negative. Luminal B (cohort 1A) defined as ER≥10%, HER2- negative with either Ki67≥20% or PR ≤20% OR grade 3 AND TIL ≥1%. High-risk ER (cohort 2A and 3A) cT3-4N0 OR clinically node positive AND grade 3 OR grade 2 with ER levels of 50% or lower or TIL≥1%. For cohort 3B: N0 status, TNBC and TIL ≥50%. For cohort 4B: N0 status, TNBC and TIL 30-49%. For cohort 5B: N0 status, TNBC and TIL ≥50%.
- Patients with multifocal/multicentric breast cancer are eligible if subtype histology as well as sufficient TIL percentages (30-49% in cohort 4B, ≥50% in cohort 5B) have been confirmed in all tumor lesions.
- evidence or suspicion of metastatic disease. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures
- other prior invasive malignancy 1) in the breast or 2) localized in the near proximity of the breast, that was treated with radiotherapy at the localization of the new breast tumor
- occult breast cancer
- previous anti-cancer hormone therapy or chemotherapy
- prior treatment with checkpoint inhibitors (including anti-PD1, -PD-L1, -CTLA-4, -LAG3)
- concurrent anti-cancer treatment, neoadjuvant therapy or another investigational drug (except for neoadjuvant chemotherapy in cohort 2A / 3A)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.