OXEL: Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for TNBC With Residual Disease

Phase 2 Completed 45 enrolled Georgetown University Bristol-Myers Squibb · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This pilot study will provide preliminary data regarding the role of PIS in predicting the benefit of immune checkpoint inhibition with or without chemotherapy for high risk patients with TNBC and residual disease after effective neoadjuvant chemotherapy.

Timeline

Start: 2018-05-21
Primary completion: 2021-11-03
Completion: 2024-05-02

Outcome

Met primary endpoint

paper primary endpoint of the OXEL trial, demonstrating that a peripheral immunoscore based on circulating immune cells reflecting immune activation was increased PMID 40274284 ↗

Publications

Toney NJ, Lynch MT, Lynce F, Mainor C, Isaacs C, Schlom J, Donahue RN. Serum analytes as predictors of disease recurrence and the duration of invasive disease-free survival in patients with triple negative breast cancer enrolled in the OXEL trial treated with immunotherapy, chemotherapy, or chemoimmunotherapy. J Immunother Cancer. 2025 Apr 23;13(4):e011379. doi: 10.1136/jitc-2024-011379.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1250 mg/m2	—
Subject	Nivolumab	Monoclonal antibody	360 mg	Intravenous