PD-1 +/- IL-4 Inhibition in ER+ Breast Cancer

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT05967884
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Arm A: Cemiplimab, Arm B: Cemiplimab + Dupilumab — DRUG
    Arm A: Cemiplimab: 350mg IV x 1 dose administered prior to surgery Arm B: Cemiplimab + Dupilumab: Cemiplimab 350mg IV x 1 dose + Dupilumab 600 mg SC x 1 dose administered prior to surgery

Study Details

This proposal is for a Window of Opportunity (WOO) clinical trial using a novel combination of two Health Canada approved agents, cemiplimab (Libtayo) and dupilumab (Dupixent), for off label use in early-stage estrogen receptor positive (ER+) breast cancer.

Key Dates

Start date
Aug 4, 2023
Status verified
Jul 2023
Primary completion
Aug 1, 2024
Completion
Aug 1, 2024

Study Design

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

Arms

  • Active Comparator: Arm A: Cemiplimab
    Arm A: Cemiplimab (n=10), 350mg IV x 1 dose administered prior to surgery.
  • Experimental: Arm B: Cemiplimab + Dupilumab
    Arm B: Cemiplimab + Dupilumab (n=10), Cemiplimab 350mg IV x 1 dose + Dupilumab 600 mg SC x 1 dose administered prior to surgery.

Primary Outcome Measure

Immune Cell Population Analysis [ Time Frame: up to 6 months ]

Central Contacts

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