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

Sponsor
Oslo University Hospital
Study ID
NCT03409198
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    Ipilimumab blocks CTLA-4 and may deplete regulatory T cells
  • Nivolumab — DRUG
    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.
  • Pegylated liposomal doxorubicin — DRUG
    Chemotherapy
  • Cyclophosphamide — DRUG
    Chemotherapy

Study Details

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.

Key Dates

Start date
Jan 21, 2018
Status verified
Feb 2024
Primary completion
May 11, 2022
Completion
May 11, 2022

Study Design

Enrollment
82 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    Chemo only (pegylated liposomal doxorubicin + cyclophosphamide)
  • Experimental: Arm B
    Chemo + ipilimumab + nivolumab

Primary Outcome Measure

Toxicity: CTCAE v4.0 [ Time Frame: 3 years ]

Related Studies