Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

November 17, 2023

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2026

Conditions
TNBC - Triple-Negative Breast CancerBreast Cancer
Interventions
DRUG

Pembrolizumab

Pembrolizumab 200 mg is administered intravenously at Week 1, then every 3 weeks during the treatment period (6 weeks). Therapy will continue for until initiation of SOC curative-intent treatment (neoadjuvant chemo therapy or surgery) at Week 7.

RADIATION

Radiation Therapy

Radiation therapy (RT) consists of 8 Gy for 3 fractions over 3 consecutive days at Week 2.

DRUG

Axatilimab

Axatilimab 1 mg/kg is administered intravenously weekly starting 1 week post- RT (Week 3). Therapy will continue until initiation of SOC curative-intent treatment (neoadjuvant chemo therapy or surgery) at Week 7.

Trial Locations (1)

90048

Cedars-Sinai Medical Center, Los Angeles

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Incyte Corporation

INDUSTRY

lead

Stephen Shiao

OTHER