Converting HR+ Breast Cancer Into an Individualized Vaccine

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 17, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
Breast Cancer
Interventions
RADIATION

Focal Radiation therapy

Focal hypo-fractionated radiation therapy 8 Gy x 3 fractions, starting day 8, every other day (M/W/F or W/F/M or F/M/W).

DRUG

Pembrolizumab (200mg IV for 30 minutes

Pembrolizumab, on day 12 (last day of radiotherapy), infused over 200mg IV over 30 minutes and then repeated every 3 weeks until disease progression or unacceptable toxicity.

BIOLOGICAL

CDX-301

Ftl-3 ligand, self-administered by subcutaneous injections at week 1, daily, for 5 consecutive days.

Trial Locations (8)

10027

WITHDRAWN

Icahn School of Medicine at Mt Sinai, New York

10065

RECRUITING

New York Presbyterian Hospital - Queens, New York

RECRUITING

Weill Cornell Medicine New York Presbyterian Hospital, New York

11215

RECRUITING

Brooklyn Methodist Hospital - NewYork Presbyterian, New York

15232

WITHDRAWN

UPMC Hillman Cancer Center, Pittsburgh

77030

RECRUITING

Houston Methodist Cancer Center, Houston

90048

WITHDRAWN

Cedars-Sinai Medical Center, Los Angeles

75390-9179

RECRUITING

UT Southwestern Medical Center, Dallas

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Celldex Therapeutics

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER

NCT03804944 - Converting HR+ Breast Cancer Into an Individualized Vaccine | Biotech Hunter | Biotech Hunter