Neoadjuvant Durvalumab and Tremelimumab Plus Radiation for High Risk Soft-Tissue Sarcoma

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

June 21, 2017

Primary Completion Date

June 21, 2024

Study Completion Date

June 21, 2024

Conditions
Soft Tissue Sarcoma
Interventions
COMBINATION_PRODUCT

Combination Radiation, Immunotherapy, Surgery

"Three doses of Durvalumab (1500 mg) and Tremelimumab (75 mg) given intravenously once every four weeks during radiotherapy prior to surgery.~Radiation therapy delivered with a minimum dose of 50 Gy and 1.8-2 Gy per fraction. Bulky sarcomas, defined as \>10 cms in greatest dimension, receive a single 15 Gy fraction of high-dose spatially fractionated (GRID) radiation therapy within 1-3 days prior to radiation therapy~Surgical resection is performed at least 5-8 weeks after cessation of radiotherapy and 4 weeks after completion of neoadjuvant immunotherapy.~Patients with no evidence of disease following surgical resection receive four additional doses and patients with evidence of disease receive nine additional doses of Durvalumab (1500 mg IV) once every four weeks unless there is clear progression of disease."

Trial Locations (3)

15212

Allegheny General Hospital, Pittsburgh

21201

University of Maryland Medical Center, Greenebaum Comprehensive Cancer Center, Baltimore

85724

University of Arizona, Tucson

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

University of Arizona

OTHER

collaborator

West Penn Allegheny Health System

OTHER

lead

University of Maryland, Baltimore

OTHER