CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 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/NCT03056001
NCT03056001Phase 2Completed
CompareCT.gov

A Pilot Study Evaluating the Safety, Tolerability, and Efficacy of Doxorubicin and Pembrolizumab in Patients With Metastatic or Unresectable Soft Tissue Sarcoma

Wake Forest University Health Sciences·interventional·Posted Feb 16, 2017·Updated Nov 18, 2023

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and Doxorubicin for Soft Tissue Sarcoma, Adult and Soft Tissue Sarcoma, Child. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of doxorubicin in combination with pembrolizumab in subjects with metastatic or unresectable soft tissue sarcoma. Based on previous studies, pembrolizumab may be an effective study treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSoft Tissue Sarcoma, Adult, Soft Tissue Sarcoma, Child
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 16, 2017
Enrollment StartMay 1, 2017
Primary CompletionNov 16, 2021
Study CompletionNov 15, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.4 years ago

Interventions

Pembrolizumabdrug

IV infusion on day 1 of each 3 week cycle, at dose of 200 mg

Doxorubicindrug

IV injection on day 1 of each 3 week cycle, starting at dose of 60 mg/m2 (may be escalated to 75 mg/m2 per investigator discretion after Cycle 1)