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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

Study Summary

This trial will help determine if a certain type of immunotherapy can help treat a certain type of breast cancer.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Immune activation measured by changes in the peripheral immunoscore (PIS) at week 6

Secondary outcome measures

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

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

2014

Completed Phase 3

~4750

Capecitabine

2013

Completed Phase 3

~3420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,469 Total Patients Enrolled

51 Trials studying Breast Cancer

8,265 Patients Enrolled for Breast Cancer

Georgetown UniversityLead Sponsor

343 Previous Clinical Trials

136,457 Total Patients Enrolled

34 Trials studying Breast Cancer

13,085 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some known side effects of Nivolumab?

"Nivolumab's safety was rated a 2 because, while there is some evidence of its safety profile from Phase 2 trials, there is no data yet to support efficacy."

Answered by AI

Can people sign up for the trial at this time?

"The clinical trial mentioned is not currently looking for candidates, based on information from clinicaltrials.gov. This study was first posted on May 21st, 2018 and updated last on March 14th, 2022; however, there are 3,527 other trials that patients can participate in at this time."

Answered by AI

How many individuals are being asked to take part in this clinical trial?

"Presently, this study is not recruiting patients. Although, it's worth noting that the trial was most recently updated on 3/14/2022 and was initially posted on 5/21/2018. If you are interested in other studies, there are 2439 trials actively searching for participants with triple negative breast neoplasms and 1088 studies for Nivolumab that need participants."

Answered by AI

What is the existing research on Nivolumab's effects?

"There are currently 1088 clinical trials underway that focus on nivolumab. Out of these, 208 have reached Phase 3. Many of the studies related to nivolumab originate in Adelaide, South Australia; however, there are 52682 locations around the world conducting similar research."

Answered by AI

What are Nivolumab's most common indications?

"Nivolumab is most often associated with the treatment of malignant neoplasms; however, it has also shown efficacy in treating unresectable melanoma, squamous cell carcinoma, and high risk of recurrence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "OXEL: Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for TNBC With Residual Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03487666.