Immunotherapy Combined With Y-90 and SBRT for Colorectal Liver Metastases

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

August 31, 2019

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2024

Conditions
Colorectal Cancer
Interventions
DRUG

Durvalumab

Durvalumab will be dosed at 1500 mg fixed dosing every 4 weeks and continued at this interval until progression or dose-limiting toxicity.

DRUG

Durvalumab and Tremelimumab

Durvalumab will be dosed at 1500 mg fixed dosing every 4 weeks and continued at this interval until progression or dose-limiting toxicity. Tremelimumab will be dosed at 75 mg every 4 weeks (same day as durvalumab infusion) for a maximum of 4 doses.

DRUG

Y-90 Selective Internal Radiation Therapy (SIRT)

Yttrium-90 microsphere therapy consists of resin beads loaded with Yttrium, a pure beta emitter with a 64.2 hour half-life. Radioembolization will be performed as standard of care therapy per current NCCN guidelines.

DRUG

Stereotactic Body Radiation Therapy (SBRT)

High-dose hypofractionated conformal external beam radiation therapy that is considered a standard of care. SBRT will also be considered for metastases that are persistent and/or progressive after Y-90 based on MR imaging and pathology from tissue biopsies.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

University of Colorado, Denver

OTHER