drugset / Trial / NCT03804944
Converting HR+ Breast Cancer Into an Individualized Vaccine
Phase 2
Recruiting
100 enrolled
Weill Medical College of Cornell University
Celldex Therapeutics · collabMerck Sharp & Dohme LLC · collabUnited States Department of Defense · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Newly diagnosed post-menopausal women with clinical stage II-III, HR+HER2- breast cancer are eligible to a randomized trial, concurrently open at five US academic institutions. Patients receiving 4 months of standard neoadjuvant hormonal therapy with letrozole are randomly assigned to one of 4 arms of a trial testing focal hypo-fractionated RT alone or with immunotherapy combinations.
Timeline
- Start
- 2020-03-17
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CDX-301 | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |