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

Sponsor
The Netherlands Cancer Institute
Study ID
NCT04159818
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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 — DRUG
    40mg/m2, weekly for two weeks
  • Low dose doxorubicin — DRUG
    15mg flat dose, weekly for 8 weeks

Study Details

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

Key Dates

Start date
Feb 21, 2020
Status verified
Mar 2022
Primary completion
Dec 15, 2022
Completion
Dec 15, 2026

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Control group
    no induction treatment, nivolumab 240 mg flat-dose, every 2 weeks
  • Experimental: Cisplatin induction
    Cisplatin 40mg/m2, weekly for two weeks, after 2 weeks followed by nivolumab 240 mg flat-dose, every 2 weeks
  • Experimental: Low dose doxorubicin induction
    Low dose doxorubicin 15mg flat dose, weekly for 8 weeks, after 2 weeks followed by nivolumab 240 mg flat-dose, every 2 weeks

Primary Outcome Measure

Progression free survival [ Time Frame: assessed monthly until progression or date of death; median 12 months ]

Central Contacts

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