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MEK Inhibitor

Pembrolizumab for Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Saranya Chumsri

Research Sponsored by Mayo Clinic

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 up to 3 years

Awards & highlights

Study Summary

This trial is testing pembrolizumab and binimetinib given together to see if it is more effective than pembrolizumab alone at treating triple negative breast cancer.

Eligible Conditions

Metastatic Triple-Negative Breast Cancer
Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Maximum tolerated dose (MTD) of pembrolizumab in combination with binimetinib using the standard 3+3 design (Phase I)

Objective response rate (ORR) as (Phase II)

Secondary outcome measures

ORR by immune-related (ir)RECIST

Overall survival (OS)

Progression free survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (binimetinib, pembrolizumab)Experimental Treatment3 Interventions

Patients receive binimetinib PO BID on days 1-14 of cycle 1 and on days 1-21 of cycle 2 and subsequent cycles. Beginning cycle 2, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycle 1 equals 14 days. Cycles 2 and beyond repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Binimetinib

2018

Completed Phase 3

~1100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,625 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,767,117 Total Patients Enrolled

83 Trials studying Breast Cancer

13,912 Patients Enrolled for Breast Cancer

Saranya ChumsriPrincipal InvestigatorMayo Clinic

8 Previous Clinical Trials

1,391 Total Patients Enrolled

Frequently Asked Questions

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

Are people with the necessary qualifications still able to join this clinical trial?

"According to the trials database, this particular study is not currently enrolling patients. This research was originally posted on September 26th, 2017 and updated as recently as December 14th, 2021. There are 3491 other clinical trials that are actively recruiting participants right now."

Answered by AI

What other pharmaceutical tests has Pembrolizumab been involved in?

"Pembrolizumab was first synthesized and studied in 2010 at City of Hope. Since then, there have been 824 completed studies with 1050 active clinical trials as of now. A large number these pembrolizumab trials are taking place in Jacksonville, Florida."

Answered by AI

What are some common treatments that use Pembrolizumab?

"Pembrolizumab is most often used as treatment for malignant neoplasms; however, it has also been known to effectively treat unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer

2017. "Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03106415.