RELATLIMAB for Breast cancer

Inclusion criteria

• {"criterion_text":"- Signed written informed consent\n- 18 years or older at moment of inclusion\n- Female gender\n- WHO performance status 0 or 1\n- 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).\n- 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%.\n- 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."}

Exclusion criteria

• {"criterion_text":"- 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\n- 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\n- occult breast cancer\n- previous anti-cancer hormone therapy or chemotherapy\n- prior treatment with checkpoint inhibitors (including anti-PD1, -PD-L1, -CTLA-4, -LAG3)\n- concurrent anti-cancer treatment, neoadjuvant therapy or another investigational drug (except for neoadjuvant chemotherapy in cohort 2A / 3A)"}

Primary endpoints

• {"endpoint_text":"- pathological complete response rate per cohort, with a pCR defined as no residual invasively growing tumor cells detected by microscopic examination in breast and axilla.","definition_or_measurement_approach":"pCR defined as no residual invasively growing tumor cells detected by microscopic examination in breast and axilla."}

Secondary endpoints

• {"endpoint_text":"- incidence, nature and severity of Adverse Events graded according to NCI-CTCAE v5.0 collected during treatment and up to 3 weeks post-surgery.\n- Radiological response using breast MRI per cohort\n- Event-free survival (EFS)\n- Overall survival (OS)\n- Immune activation after pre-operative nivolumab, either as monotherapy or in combination with ipilimumab or relatlimab or novel IO combinations","definition_or_measurement_approach":"Incidence/nature/severity of AEs: graded according to NCI-CTCAE v5.0, collected during treatment and up to 3 weeks post-surgery. Radiological response: assessed using breast MRI per cohort. EFS and OS: standard survival endpoints (definitions not further specified in the provided data). Immune activation: measured post-treatment (specific assays/measures not specified in the provided data)."}

Netherlands

Earliest CTIS Part Ii Submission Date

10-06-2024

Latest Decision Or Authorization Date

29-07-2025

Processing Time Days

414

Number Of Sites

1

Number Of Participants

120

Primary sponsor

Full Name

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands