Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT04108481
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Immunotherapy
  • Yttrium-90 RadioEmbolization — RADIATION
    Microscopic radioactive particles (TheraSphere®) will be used for radioembolization to deliver the Y90 drug to the liver

Study Details

This clinical trial will be conducted as a single-center, open-label, Phase I/2 trial to evaluate the feasibility and safety of Yttrium-90 radioembolization (Y90-RE) in combination with a fixed dose of of immunotherapy (durvalumab - 750 mg) in subjects with liver-predominant, metastatic colorectal cancer (mCRC), which is mismatch repair proficient/microsatellite stable (pMMR/MSS).

Key Dates

Start date
Oct 5, 2020
Status verified
Mar 2025
Primary completion
Nov 17, 2023
Completion
Nov 17, 2023

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Y90-RE in combination with immunotherapy (durvalumab)
    The treatment phase starts of with the immunotherapy drug (durvalumab) - "priming doses" every 2 weeks prior to patient getting mapped and ready for treatment with Y90-RadioEmbolization. Post-Y90-RE, treatment is approximately 2 months in combination with fixed doses (750 mg) of durvalumab. The number and timing of doses of durvalumab each patient will receive will depend on the dose level the patient is assigned to (range 2-5 doses of immunotherapy). A single patient will be treated per dose level until the first dose limiting toxicity (DLT) is recorded. Once the first DLT is recorded, two additional patients are treated at the same dose level and the trial reverts to a standard 3+3 design. Up to 6 patients will be treated at each dose level. The maximum tolerated dose (MTD) will be defined as the highest dose level for which at most 1 out of 6 patients experience a DLT.

Primary Outcome Measure

Determine the maximum tolerated dose (MTD) of Yttrium-90 radioembolization combined with immunotherapy durvalumab to treat liver-predominant metastatic colorectal cancer (mCRC) [ Time Frame: Initiation of treatment up to 8 weeks and 2 doses ("priming") of immunotherapy prior to Y90-RE. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals and ClinicsIowa CityIowa52242-

Find similar trials in Iowa City, IA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Iowa Hospitals and Clinics· Iowa City, IA

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