NCT02636725

Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Jonathan Trent, MD, PhD · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Arm 2, the Axitinib Plus Pembrolizumab Expansion Cohort, did not open.

Conditions

• Alveolar Soft Part Sarcoma
• Soft Tissue Sarcomas

Interventions

Type	Name	Description
DRUG	Axitinib	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.
DRUG	Pembrolizumab	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.

Timeline

• Start date: 2016-04-19
• Primary completion: 2018-05-08
• Completion: 2023-03-03
• First posted: 2015-12-22
• Last updated: 2024-07-12
• Results posted: 2021-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study