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Phase IIb Study Evaluating Immunogenic Chemotherapy Combined with Ipilimumab and Nivolumab in Breast Cancer

NCT03409198 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-10-15

No results posted yet for this study

Summary

Breast cancer is rarely curable after metastasis, and the therapeutic options are limited. Interestingly, the host immune response is strongly predictive for the effect of chemotherapy in subgroups of patients with breast cancer. The aim is to release the brake on the immune response by use of ipilimumab, which blocks CTLA-4 and may deplete regulatory T cells, combined with nivolumab (anti PD1). Importantly, it is possible that non-responders to nivolumab/ipilimumab (nivo/ipi) can be turned responders by use of immunogenic chemotherapy.

Conditions

Interventions

DRUG

Ipilimumab

Ipilimumab blocks CTLA-4 and may deplete regulatory T cells

DRUG

Nivolumab

Nivolumab blocks PD-1 and thereby enhances the effector phase of the immune reaction, by enabling T cells to kill tumor cells and engage effectively with other PD-L1 expressing targets.

DRUG

Pegylated liposomal doxorubicin

Chemotherapy

DRUG

Cyclophosphamide

Chemotherapy

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Helse Stavanger HF

    collaborator OTHER_GOV

  • Helse Sor-Ost

    collaborator OTHER_GOV

  • Sorlandet Hospital HF

    collaborator OTHER_GOV

  • Jules Bordet Institute

    collaborator OTHER

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    collaborator OTHER

  • Centre Hospitalier Universitaire UCLouvain Namur

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Jon Amund Kyte · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-21
Primary Completion
2022-05-11
Completion
2022-05-11

Countries

  • Belgium
  • Norway

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 NCT03409198 on ClinicalTrials.gov