LCI-BRE-H2N-PEPP-001: A Pilot Study of Paclitaxel Plus Pembrolizumab in Patients With Metastatic HER2-Negative Breast Cancer (The PePPy Trial)
Overview
- Phase
- Phase 2
- Intervention
- Pembrolizumab
- Conditions
- Breast - Female
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of Participants With at Least One Grade 3 or 4 Treatment-related Adverse Event
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objective of this study is to assess the safety and feasibility of the following two regimens: Cohort A) phased regimen of pembrolizumab in which paclitaxel is followed by paclitaxel plus pembrolizumab and Cohort B) concurrent regimen of paclitaxel plus pembrolizumab. The primary safety objective is to evaluate the overall grade 3 or 4 treatment-related adverse event rate for each cohort and compare them to relevant historical controls.
Detailed Description
This is an open-label randomized pilot research study to determine if the study drug, pembrolizumab, is safe to use in combination with a chemotherapy drug called paclitaxel. This study will have the following two regimens: Cohort A) phased regimen of pembrolizumab in which paclitaxel is followed by paclitaxel plus pembrolizumab and Cohort B) concurrent regimen of paclitaxel plus pembrolizumab. A total of 40 evaluable subjects will be enrolled over an enrollment period of 18-24 months. The study is planned to enroll approximately 20 evaluable subjects in each treatment cohort.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A (Phased Pembrolizumab Regimen)
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.
Intervention: Pembrolizumab
Arm A (Phased Pembrolizumab Regimen)
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.
Intervention: Paclitaxel
Arm B (Concurrent Pembrolizumab Regimen)
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.
Intervention: Pembrolizumab
Arm B (Concurrent Pembrolizumab Regimen)
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.
Intervention: Paclitaxel
Outcomes
Primary Outcomes
Number of Participants With at Least One Grade 3 or 4 Treatment-related Adverse Event
Time Frame: From enrollment to at least 30 days following cessation of study treatment. The median time on treatment was 5.5 months.
Grade 3 or 4 study treatment-related adverse events will be determined for each subject as a binary variable indicating whether or not the subject experienced at least one grade 3 or 4 study treatment-related adverse events according to the NCI Common Terminology for Adverse Events, version 4.0. An adverse event will be considered study treatment related if it is determined that the event is at least possibly related to either paclitaxel, pembrolizumab, or both.
Secondary Outcomes
- Number of Subjects With an Objective Response (Per RECIST V1.1)(From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity (subjects were on treatment for a median of 5.5 months))
- Progression-free Survival (PFS) Per RECIST 1.1(From treatment start date to date of progression/death, or censored as described; assessed for approximately 2 years.)
- Overall Survival (OS)(From date of treatment start to date of death, or censored as described; assessed for approximately 5 years.)
- Number of Subjects With Disease Control (Per RECIST V1.1)(From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity (subjects were on treatment for a median of 5.5 months))
- Duration of Response (DoR)(From date of response to date of progression/death, or censored as described above; assessed for approximately 2 years.)