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Anti-microtubule agent
Pembrolizumab for Breast (PePPy Trial)
Phase 2
Waitlist Available
Research Sponsored by Wake Forest University Health Sciences
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 from date of response to date of progression/death, or censored as described above; assessed for approximately 2 years.
Awards & highlights
PePPy Trial Summary
This trial is testing two different ways of giving paclitaxel and pembrolizumab to see which is better and has fewer side effects.
Eligible Conditions
- Breast
- Breast Cancer
PePPy Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from treatment start date to date of progression/death, or censored as described; assessed for approximately 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment start date to date of progression/death, or censored as described; assessed for approximately 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With at Least One Grade 3 or 4 Treatment-related Adverse Event
Secondary outcome measures
Duration of Response (DoR)
Number of Subjects With Disease Control (Per RECIST V1.1)
Number of Subjects With an Objective Response (Per RECIST V1.1)
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
PePPy Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (Concurrent Pembrolizumab Regimen)Experimental Treatment2 Interventions
Pembrolizumab will be given as an IV infusion on day 1 before paclitaxel every 21 (+/- 3) days. Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days.
Group II: Arm A (Phased Pembrolizumab Regimen)Experimental Treatment2 Interventions
Paclitaxel will be given as an IV infusion over 60 minutes, on days 1 and 8 every 21 (+/- 3) days during Cycles 1 and 2. No pembrolizumab will be given during Cycles 1 and 2. Starting with cycle 3 and subsequent cycles, pembrolizumab will be given as an IV infusion over 30 minutes before paclitaxel on day 1 every 21 (+/- 3) days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,106 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,686 Total Patients Enrolled
2 Trials studying Breast
109 Patients Enrolled for Breast
Antoinette Tan, MDLead Sponsor
2 Previous Clinical Trials
40 Total Patients Enrolled
Frequently Asked Questions
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