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Tavo + Pembrolizumab/Chemotherapy for Breast Cancer
Study Summary
This trial is testing a new cancer treatment that uses a combination of drugs and electrical pulses to kill tumors. The study will enroll people with a certain type of breast cancer that has spread to the skin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have not received blood products or growth factors in the last 2 weeks.I have received a transplant from another person.I have had at least one treatment with chemotherapy or immunotherapy for my condition.My cancer is PD-L1 negative based on a recent test.I have active hepatitis B or C, but it's under control with treatment.I am on high-dose steroids or other drugs that weaken my immune system.I have a cancer lesion that can be safely reached for treatment.I agree to use birth control during and after the study for at least 120 days.I have not received a live vaccine within the last 30 days.I am highly allergic to pembrolizumab or similar medications.I haven't taken any cancer treatment or immunotherapy in the last 14 days.My breast cancer is triple-negative, not driven by estrogen, progesterone, or HER2.I have stable brain metastases not requiring steroids for 14 days.I have been diagnosed with HIV.I have had pneumonitis treated with steroids or have it now.My breast cancer cannot be removed by surgery and has spread.I haven't had systemic therapy for advanced cancer and no disease progression 6 months after my last treatment.I am a male who is either surgically sterile or will use contraception and not donate sperm during and for 120 days after the study.I have a tumor that can be biopsied again on the specified date.I have an autoimmune disease treated with medication in the last 2 years.I have a history of interstitial lung disease.I have another cancer besides skin or in situ cervical cancer that needs treatment.I still have side effects from previous treatments that are not mild.I am allergic or cannot tolerate most chemotherapy, but can handle at least one type approved for this trial.I am fully active or can carry out light work.I am currently being treated for an infection.I am 18 years old or older.I can provide a recent biopsy of my tumor.My organ functions are within normal ranges as per recent tests.I am a woman who can have children and have a recent negative pregnancy test.
- Group 1: TAVO-EP plus IV pembrolizumab with chemotherapy
- Group 2: TAVO-EP plus IV pembrolizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA sanctioned Pembrolizumab for medical use?
"Pembrolizumab's safety was assessed at a level 2 since this is a phase two trial and there are some data points confirming its security but none indicating its effectiveness."
Are there any openings for potential participants at this point in time?
"Affirmative. According to clinicaltrials.gov, this medical study is actively searching for participants and was initially made available on the 11th of October 2018 with a recent update posted on the 18th of April 2022. This research requires 65 individuals from 8 different sites."
To what conditions is Pembrolizumab routinely prescribed?
"Pembrolizumab is predominantly prescribed for those suffering with inoperable melanoma, yet can also be deployed to manage microsatellite instability high, the risk of relapse, and various other medical conditions."
Has Pembrolizumab been studied before in a research setting?
"Currently, there are 1697 studies researching Pembrolizumab with 323 trials in the final stage. Mostly situated within Shanghai, China, these clinical trials span a total of 74518 locations."
What results is this clinical experiment endeavoring to achieve?
"The primary outcome for Merck Sharp & Dohme LLC's trial, which will be monitored over an extended period of two years, is Cohort 1: Objective Response Rate (ORR). Further outcomes being examined include Progression Free Survival (PFS), Duration of Response(DOR) and Objective Response Rate (ORR). These metrics are respectively determined by Investigator based on RECIST v1.1; both Investigator and BICR review based on RECIST v1.1; as well as a third assessment with ORR evaluated through the same platform."
To what extent is the enrollment in this experiment limited?
"Yes, the trial is still open for enrollment according to information on clinicaltrials.gov. This study opened its recruitment period in October 2018 and was last updated in April 2022. 65 participants are being sought out between 8 medical sites."
Could you provide an estimate of the number of facilities conducting this clinical research in city?
"Currently, 8 clinics have been identified to enroll patients in this trial; these include The Lundquist Institute (Torrance), University of Colorado Cancer Center (Aurora) and University of Chicago (Chicago). Moreover, there are 5 other sites participating."
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