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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04159818
Other study ID # N19TON
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 21, 2020
Est. completion date December 15, 2026

Study information

Verified date March 2022
Source The Netherlands Cancer Institute
Contact Marleen Kok, MD
Phone +3120 512
Email m.kok@nki.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single center non-blinded randomized multi-cohort non-comparative phase II trial with a Simon's two-stage design.


Description:

In the first stage, 13 evaluable patients will be accrued per cohort. Evaluable is defined as: at least one administration of nivolumab and availability of paired biopsies for immunohistochemistry (for induction treatment cohorts pre-induction and pre-nivolumab biopsies). If there are 1 or no responses observed in these 13 patients, the cohort will be stopped. Otherwise, 21 additional patients will be accrued for a total of 34.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date December 15, 2026
Est. primary completion date December 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Metastatic or incurable locally advanced triple negative breast cancer (ER < 10%, HER2 IHC 0,1+ or 2+ with no amplification) - Metastatic lesion accessible for histological biopsy - 18 years or older - Maximum of three lines of chemotherapy for metastatic disease and with evidence of progression of disease. Treatment with low-dose doxorubicin in the palliative setting is not allowed. - WHO performance status of 0 or 1 - Measurable or evaluable disease according to RECIST 1.1 - Disease Free Interval (defined as time between first diagnosis or locoregional recurrence and first metastasis) longer than 1 year - Subjects with brain metastases are eligible if these are not symptomatic and free of progression of at least 4 weeks - A maximum dosage of 360 mg/m2 of anthracyclines and no previous anthracycline-related cardiac toxicity. In case of radiation in the cardiac area, hypertension, diabetes mellitus or hypercholesterolemia, the left ventricular ejection fraction must be 50% or higher. - Adequate bone marrow, kidney and liver function Exclusion Criteria: - uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris - known history of leptomeningeal disease localization - history of having received other anticancer therapies within 2 weeks of start of the study drug - history of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (>10 mgl daily prednisone equivalents) or chronic infections. - prior treatment with immune checkpoint inhibitors. - active other cancer - history of uncontrolled serious medical or psychiatric illness - current pregnancy or breastfeeding

Study Design


Intervention

Drug:
Nivolumab
240 mg flat-dose, every 2 weeks. From 20 weeks onwards, nivolumab will be administered every 4 weeks with a flat-dose of 480 mg starting from week 20 onwards
Cisplatin
40mg/m2, weekly for two weeks
Low dose doxorubicin
15mg flat dose, weekly for 8 weeks

Locations

Country Name City State
Netherlands Antoni van Leeuwenhoek Amsterdam

Sponsors (2)

Lead Sponsor Collaborator
The Netherlands Cancer Institute Bristol-Myers Squibb

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival Time from randomization to date of first tumor progression assessed monthly until progression or date of death; median 12 months
Secondary Overall response rate complete response or partial response according to iRECIST and RECIST1.1 assessed at week 6, 12 and 20 and every 8 weeks thereafter; assessed up to 120 months
Secondary Clinical benefit rate Beneficial response (complete response, partial response or stable disease) according to RECIST 1.1 and iRECIST assessed at week 6, 12 and 20 and every 8 weeks thereafter; assessed up to 120 months
Secondary Overall survival time from nivolumab initiation to death from any cause assessed monthly until date of death; median 12 months
Secondary Toxicity of all study regimens adverse events will be graded according to NCI Common Toxicity Criteria v 5.0 assessed until 100 days after of treatment end
Secondary Progression Free Survival after 6 cycles the number of patients free of progression after 6 cycles of nivolumab time from nivolumab initiation to tumor progression or death from any cause; assessed up to 120 months
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