CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Pembrolizumab 200 mgfrom 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/NCT02440425
NCT02440425Phase 2Completed

Phase 2 Trial of Dose Dense (Weekly) Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Recurrent Ovarian Cancer

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted May 12, 2015·Updated Oct 7, 2022

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and Paclitaxel for Ovarian Cancer. Completed, enrolled 42 participants across 3 sites.

Detailed Summary

The purpose of this study is to find out if the combination of Paclitaxel once per week with Pembrolizumab once every 3 weeks will help participants with this disease. Researchers want to find out the effectiveness of the drug combination to improve the delay of cancer progression or death and compare it to historical data for weekly paclitaxel alone, and assess safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 12, 2015
Enrollment StartOct 20, 2015
Primary CompletionApr 1, 2020
Study CompletionMay 27, 2021
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 11.1 years ago

Interventions

Pembrolizumabdrug

Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.

Paclitaxeldrug

Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.