CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03018080
NCT03018080Phase 2Completed
CompareCT.gov

LCI-BRE-H2N-PEPP-001: A Pilot Study of Paclitaxel Plus Pembrolizumab in Patients With Metastatic HER2-Negative Breast Cancer (The PePPy Trial)

Wake Forest University Health Sciences·interventional·Posted Jan 11, 2017·Updated Aug 4, 2023

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and Paclitaxel for Breast - Female and Male Breast Cancer. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast - Female, Male Breast Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 11, 2017
Enrollment StartJun 12, 2017
Primary CompletionJul 29, 2021
Study CompletionAug 5, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 9.5 years ago

Interventions

Pembrolizumabdrug

IV (in the vein) on day 1 of a 21 day cycle

Paclitaxeldrug

IV (in the vein) on days 1 and 8 of a 21 day cycle