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

Sponsor
University of Colorado, Denver
Study ID
NCT03802747
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab will be dosed at 1500 mg fixed dosing every 4 weeks and continued at this interval until progression or dose-limiting toxicity.
  • Durvalumab and Tremelimumab — DRUG
    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.
  • Y-90 Selective Internal Radiation Therapy (SIRT) — DRUG
    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.
  • Stereotactic Body Radiation Therapy (SBRT) — DRUG
    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.

Study Details

This study is evaluating the combination of Y-90 radioembolization followed by SBRT with the immunotherapy drugs, durvalumab and tremelimumab, to improve disease control of liver metastases for patients with microsatellite stable colorectal cancer.

Key Dates

Start date
Aug 31, 2019
Status verified
Dec 2024
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Y-90, SBRT, and Durvalumab Alone
    Six patients will be enrolled in cohorts of three to be administered Y-90, SBRT, and Druvalumab.
  • Experimental: Y-90, SBRT, and Durvalumab + Tremelimumab
    Six patients will be enrolled in cohorts of three to be administered Y-90, SBRT, and Druvalumab + Tremelimumab.

Primary Outcome Measure

Incidence of Treatment Related Adverse Events [ Time Frame: Start of study to 3 months post treatment completion, up to 5 years ]

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