TheraSphere With Durvalumab and Tremelimumab for HCC

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Boston Scientific Corporation
Study ID
NCT05063565
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • TheraSphere Y-90 glass microsphere therapy — DEVICE
    TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.
  • Durvalumab (Imfinzi) immunotherapy — DRUG
    1500 mg, every 4 weeks that continues for a maximum duration of 18 months or until confirmed progression (by site assessment), unacceptable toxicity, study withdrawal, or study early termination by the sponsor. Treatment beyond confirmed radiographic progression is permitted per patient consent if the following criteria are met: * Absence of clinical symptoms or signs indicating clinically significant disease progression * No decline in performance status * Absence of rapid disease progression or threat to vital organs or critical anatomical sites (i.e. new CNS metastasis, respiratory failure due to tumor compression, spinal cord compression) requiring urgent alternative medical intervention * No other treatment discontinuation criteria are met
  • Tremelimumab immunotherapy — DRUG
    300 mg, single administration

Study Details

The objective of the ROWAN clinical study is to assess the efficacy of local tumor control in HCC patients who receive TheraSphere followed by durvalumab and tremelimumab.

Key Dates

Start date
Nov 3, 2023
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TheraSphere followed by Durvalumab and Tremelimumab
    TheraSphere followed by Tremelimumab plus Durvalumab administered once, then repeated administration of Durvalumab monthly up 18 months.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Start of Treatment (Day 1) up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated) ]

Locations (13)

FacilityCityStateZIPSite coordinators
University of Arizona- Banner HealthTucsonArizona85724-
University of California San DiegoSan DiegoCalifornia92093-
University of California San FranciscoSan FranciscoCalifornia94143-
Georgetown UniversityWashington D.C.District of Columbia20007-
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
Mayo ClinicJacksonvilleFlorida32224-
Rush University Medical CenterChicagoIllinois60612-
University of Chicago HospitalChicagoIllinois60637-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
University of MinnesotaMinneapolisMinnesota55455-
Washington University (Barnes-Jewish Hospital)St LouisMissouri63101-
Columbia University Irving Medical CenterNew YorkNew York10032-
Intermountain HealthSalt Lake CityUtah84157-

Find similar trials in Tucson, AZ

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
University of Arizona- Banner Health· Tucson, AZUniversity of California San Diego· San Diego, CAUniversity of California San Francisco· San Francisco, CAGeorgetown University· Washington D.C., DCMedStar Washington Hospital Center· Washington D.C., DCMayo Clinic· Jacksonville, FL

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