TRIO Bladder: A Study of Durvalumab Plus Tremelimumab Followed by Concurrent Durvalumab Plus Bladder Radiation in Muscle-Invasive Bladder Cancer

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Daniel George, MD
Study ID
NCT04073160
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Tremelimumab — DRUG
    Tremelimumab and durvalumab will be administered in combination during cycles 1 and 2. Tremelimumab will be administered intravenously at a dose of 75 mg on cycle 1 day 1 and cycle 2 day 1. Cycles are 4 weeks long.
  • Durvalumab — DRUG
    Tremelimumab and durvalumab will be administered in combination during cycles 1 and 2. Durvalumab will be administered intravenously at a dose of 1500 mg on cycle 1 day 1 and cycle 2 day 1. Cycles are 4 weeks long. Eligible subjects may go on to receive a combination of durvalumab and bladder radiation during cycles 3 and 4. Durvalumab will be administered intravenously at a dose of 1500 mg on cycle 3 day 1 and cycle 4 day 1. At the completion of radiation, eligible subjects may continue to receive durvalumab for a maximum of one year from the date of their initial dose. Durvalumab will be administered intravenously at a dose of 1500 mg on the first day of each cycle.
  • Bladder radiation — RADIATION
    During the durvalumab cycles 3 and 4, eligible subjects will receive 6.5 weeks of radiation to the bladder. Radiation will be administered at a dose of 64 Gy in daily 2 Gy fractions.
  • Intravesicular Therapy — DRUG
    Subjects will receive intravesicular therapy, if clinically indicated during cycles 5 and beyond of durvalumab administration. Intravesicular therapy will consist of BCG, gemcitabine, mitomycin or a similar drug, depending on institutional standards and treating provider's discretion.

Study Details

The purpose of this study is to describe the safety and tolerability of Durvalumab plus Tremelimumab followed by concurrent Durvalumab plus bladder radiation in patients with localized muscle invasive urothelial carcinoma of the bladder, who are either Decipher-Non-Basal OR Decipher-Basal and cisplatin-ineligible. Eligible subjects will receive 2 cycles of Durvalumab plus Tremelimumab followed by imaging and cystoscopy. Subjects whose cancer responds or is stable will receive a combination of 2 cycles of Durvalumab plus 6.5 weeks of radiation to the bladder followed by imaging and a TURBT. Subjects whose cancer continues to respond and meets certain criteria will continue to receive Durvalumab for up to 12 months from initial dose or until the cancer recoccurs or progresses, whichever occurs earlier. During this time, subjects may also receive intravesicular therapy if clinically indicated. Subjects will be followed for 5 years from initial dose.

Key Dates

Start date
Jun 30, 2020
Status verified
Jul 2020
Primary completion
Jul 31, 2021
Completion
Jan 31, 2026

Study Design

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

Arms

  • Experimental: Decipher Bladder test subtype non-basal
    Subjects with localized muscle invasive urothelial carcinoma of the bladder, whose tumor is Decipher Bladder test subtype non-basal
  • Experimental: Decipher Bladder test subtype basal and cisplatin-ineligible
    Subjects with localized muscle invasive urothelial carcinoma of the bladder, whose tumor is Decipher Bladder test subtype basal and the subject is cisplatin-ineligible

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 90 days after the last dose of study drug(s) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Duke University Medical Center· Durham, NC

Related Studies