Nivolumab After Induction Treatment in Triple-negative Breast Cancer (TNBC) Patients

Phase 2 Unknown 84 enrolled The Netherlands Cancer Institute Bristol-Myers Squibb · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a single center non-blinded randomized non-comparative phase II trial. The first stage of the trial consists of five arms ( with induction treatment followed by nivolumab, 1 with no induction treatment before nivolumab). For the second stage, the number of arms will be reduced based on the results obtained in the first stage.

Timeline

Start: 2015-08
Primary completion: 2023-12
Completion: 2025-08

Publications

Lin AY, Isaeva OI, Deger T, Geurts VCM, Vessies DCL, Voorwerk L, Slagter M, Moore KS, van der Leest P, Martens JWM, van den Broek D, Wessels LFA, Kok M. CfDNA-based copy-number dynamics during anti-PD1 treatment in metastatic triple negative breast cancer. Cell Rep Med. 2025 Dec 16;6(12):102512. doi: 10.1016/j.xcrm.2025.102512.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cisplatin	Other / unclassified	40 mg/m2	—
Comparator	Cyclophosphamide	Other / unclassified	50 mg	Oral
Comparator	Doxorubicin	Other / unclassified	15 mg	—
Comparator	Nivolumab	Monoclonal antibody	3 mg/kg	—

Nivolumab After Induction Treatment in Triple-negative Breast Cancer (TNBC) Patients

Summary

Timeline

Publications

Drugs

Indications