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Nivolumab for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a treatment that helps the immune system attack cancer cells, sometimes combined with chemotherapy, for high-risk breast cancer patients who still have cancer after initial treatment.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Immune activation measured by changes in the peripheral immunoscore (PIS) at week 6
Secondary study objectives
Circulating tumor DNA
Distant recurrence free survival (DRFS) and Overall Survival
Grade 3 and 4 toxicities according to the National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.03]
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm CExperimental Treatment2 Interventions
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Group II: Arm AExperimental Treatment1 Intervention
Nivolumab 360 mg iv q3weeks for x 6 cycles
Group III: Arm BActive Control1 Intervention
Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Capecitabine
2013
Completed Phase 3
~3960

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,524 Total Patients Enrolled
51 Trials studying Breast Cancer
8,247 Patients Enrolled for Breast Cancer
Georgetown UniversityLead Sponsor
348 Previous Clinical Trials
137,257 Total Patients Enrolled
33 Trials studying Breast Cancer
11,175 Patients Enrolled for Breast Cancer
Candace Mainor, MDStudy ChairMedStar Georgetown University Hospital
3 Previous Clinical Trials
76 Total Patients Enrolled
1 Trials studying Breast Cancer
11 Patients Enrolled for Breast Cancer
~6 spots leftby Nov 2025
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