NCT02499367

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

Adaptive Phase II Randomized Non-comparative Trial of Nivolumab After Induction Treatment in Triple-negative Breast Cancer (TNBC) Patients: TONIC-trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Triple negative breast cancer (TNBC) patients have a relatively high relapse rate and upon relapse the median overall survival is less than a year. No targeted therapies are currently available for this subgroup. Compared to other breast cancer subtypes, the percentage of tumor-infiltrating lymphocytes (TILs) is significantly higher in TNBC. Given the durable responses induced by the immune checkpoint inhibitor nivolumab in other advanced solid cancers, immunotherapeutic approaches, such as blockade of PD-1 by nivolumab may be the key to treat TNBC. Moreover, since classical anticancer agents can stimulate immune effector cells, the investigators hypothesize that short-term induction treatment with radiation, doxorubicin, cyclophosphamide or cisplatin induces an anticancer immune response resulting in synergistic activity with nivolumab.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	nivolumab 3 mg/kg, every 2 weeks after induction treatment
RADIATION	Radiation therapy	20 Gy to metastatic lesion
DRUG	Low dose doxorubicin	15 mg flat dose, once weekly for 2 weeks
DRUG	Cyclophosphamide	metronomic schedule, 50 mg daily orally for 2 weeks
DRUG	Cisplatin	40 mg/m2, weekly for 2 weeks

Timeline

• Start date: 2015-08-01
• Primary completion: 2023-12-01
• Completion: 2025-08-01
• First posted: 2015-07-16
• Last updated: 2022-03-22

Locations

1 site across 1 country: Netherlands