A Phase II Multicenter Study of Chemotherapy Versus Chemotherapy Plus Durvalumab (MEDI 4736) in Patients With Lymph Node Positive Urothelial Carcinoma of the Bladder

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05137262
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Abiraterone acetate — OTHER
    Given by IV
  • Durvalumab — DRUG
    Given by IV
  • Methotrexate — DRUG
    Given by IV
  • Vinblastine — DRUG
    Given by IV
  • Doxorubicin Hydrochloride — DRUG
    Given by IV
  • Cisplatin — DRUG
    Given by IV

Study Details

This is a phase II randomized study of standard of care (SOC) neo-adjuvant cisplatin chemotherapy (NAC) versus NAC plus durvalumab in patients with either clinical or pathologic intra-pelvic node-positive urothelial carcinoma of the bladder. Patients with cTanyN1-3M0 via American Joint Committee on Cancer (AJCC) 8th edition staging30 will be considered tor enrollment in this trial. We plan to enroll 60 patients. Patients will be randomized 2:1 to the intervention arm with durvalumab plus NAC vs SOC NAC. In patients randomized to receive, durvalumab will be continued as maintenance every 4 weeks until either relapse or 1 year, whichever event occurs first. Tissue collection will occur as a biopsy prior to initiation of neo-adjuvant therapy via both transurethral biopsy of bladder and lymph node biopsy. Tissue will again be collected at the time of radical cystectomy or, in patients who are no longer surgical candidates, in the form of biopsy as standard of care. Blood and urine will be collected at baseline, week 2, week 6, week 16, and at the 6 week-post surgery visit for analysis of correlative studies.

Key Dates

Start date
Oct 13, 2021
Status verified
Feb 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Standard of Care with dose-dense MVAC
    The patient will receive treatment every 14 days for up to 6 cycles in the neoadjuvant setting.
  • Experimental: Arm B: Intervention with dose-dense MVAC plus Durvalumab
    Durvalumab will be administered one week prior to the initial cycle of dose-dense MVAC and then with each additional cycle of dose-dense MVAC on Arm B

Primary Outcome Measure

To estimate the difference in the pathologic complete response rate. [ Time Frame: through study completion, an average of 1 year ]

Locations (2)

FacilityCityStateZIPSite coordinators
Indiana UniversityBloomingtonIndiana47405-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Bloomington, IN

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Indiana University· Bloomington, INM D Anderson Cancer Center· Houston, TX

Related Studies