CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
Axitinib +1 moredrug
Likely dose
Axitinib 5 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/NCT02636725
NCT02636725Phase 2Completed

A Phase II Trial of Concurrent Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma (ASPS) and Other Soft Tissue Sarcomas (STS)

Jonathan Trent, MD, PhD·interventional·Posted Dec 22, 2015·Updated Jul 12, 2024

In Brief

A Phase 2 clinical trial evaluating Axitinib and Pembrolizumab for Alveolar Soft Part Sarcoma and Soft Tissue Sarcomas. Completed, enrolled 33 participants across 1 site.

Detailed Summary

The purpose of this research study is to test if Axitinib together with Pembrolizumab can slow tumor growth and know the side effects of the combination treatment.

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 22, 2015
Enrollment StartApr 19, 2016
Primary CompletionMay 8, 2018
Study CompletionMar 3, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.5 years ago

Interventions

Axitinibdrug

5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.

Pembrolizumabdrug

200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.