CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Nivolumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03487666
NCT03487666Phase 2Completed
CompareCT.gov

OXEL: A Pilot Study of Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease Following Neoadjuvant Chemotherapy

Georgetown University·interventional·Posted Apr 4, 2018·Updated Dec 3, 2024

In Brief

A Phase 2 clinical trial evaluating Nivolumab and Capecitabine for Triple Negative Breast Cancer. Completed, enrolled 45 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTriple Negative Breast Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 4, 2018
Enrollment StartMay 21, 2018
Primary CompletionNov 3, 2021
Study CompletionMay 2, 2024
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.2 years ago

Interventions

Nivolumabdrug

Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.

Capecitabinedrug

Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects