MedTrace Logo

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

NCT04159818 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-03-22

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Marleen Kok, MD · NKI-AvL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-21
Primary Completion
2022-12-15
Completion
2026-12-15

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04159818 on ClinicalTrials.gov