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RECRUITING
NCT04159818
PHASE2

Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients

Sponsor: The Netherlands Cancer Institute

View on ClinicalTrials.gov

Summary

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

Official title: Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients: the TONIC-2 Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2020-02-21

Completion Date

2026-12-15

Last Updated

2022-03-22

Healthy Volunteers

No

Interventions

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

DRUG

Cisplatin

40mg/m2, weekly for two weeks

DRUG

Low dose doxorubicin

15mg flat dose, weekly for 8 weeks

Locations (1)

Antoni van Leeuwenhoek

Amsterdam, Netherlands