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

PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

April 19, 2016

Primary Completion Date

May 8, 2018

Study Completion Date

March 3, 2023

Conditions
Alveolar Soft Part SarcomaSoft Tissue Sarcomas
Interventions
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.

Trial Locations (1)

33136

University of Miami, Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Pfizer

INDUSTRY

lead

Jonathan Trent, MD, PhD

OTHER

NCT02636725 - Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas | Biotech Hunter | Biotech Hunter