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Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO

NCT03815890 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-05-30

No results posted yet for this study

Summary

To determine whether short-term pre-operative nivolumab either as monotherapy or in combination with low dose doxorubicin or novel IO combinations can induce immune activation in early BC.

Conditions

Interventions

DRUG

Nivolumab

2 courses 240 mg flat dose

DRUG

Ipilimumab

single dose ipilimumab (1mg/kg) at day 1

DRUG

Ipilimumab

two courses ipilimumab (1mg/kg) at day 1 and 21

Sponsors & Collaborators

Principal Investigators

  • M Kok, MD · NKI-AvL

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-04
Primary Completion
2031-01-01
Completion
2033-01-01

Countries

  • Netherlands

Study Locations

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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 NCT03815890 on ClinicalTrials.gov