A Study of Risk Enabled Therapy After Neoadjuvant Immunochemotherapy for Bladder Cancer

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Fox Chase Cancer Center
Study ID
NCT04506554
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Muscle-Invasive Bladder Carcinoma

Eligibility Criteria

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

Interventions

  • AMVAC + Nivolumab — DRUG
    Nivolumab 240mg will be administered intravenously for 3 doses - on days 1, 15 and 29. AMVAC will be dosed intravenously every 2 weeks for 3 doses on days 1, 15 and 29 with Neulasta or equivalent. Standard AMVAC dose is as follows: methotrexate 30mg/m2, vinblastine 3mg/m2, doxorubicin 30mg/m2, and cisplatin 70mg/m2.

Study Details

Neoadjuvant accelerated methotrexate/vinblastine/adriamycin/cisplatin (AMVAC) in combination with nivolumab is under evaluation for the treatment of muscle invasive bladder cancer (MIBC). Patients with pre-specified tumor mutations and complete clinical response with neoadjuvant therapy will preserve their bladders and go on active surveillance.

Key Dates

Start date
Dec 1, 2020
Status verified
Jul 2025
Primary completion
May 31, 2026
Completion
Nov 30, 2028

Study Design

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

Arms

  • Experimental: AMVAC + nivolumab
    This will be a single-arm, open-label, multicenter phase 2 study of neoadjuvant nivolumab with AMVAC. Approximately 70 evaluable patients will be enrolled into this study. Eligible patients will be those with diagnosis of muscle invasive urothelial carcinoma of the bladder who are cT2 or cT3 but not clinical N1 at diagnosis. Clinical stage is confirmed by transurethral resection of bladder tumor (TURBT#1).

Primary Outcome Measure

Incidence of Metastasis-free survival (MFS) [ Time Frame: 2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Fox Chase Cancer Center - PhiladelphiaPhiladelphiaPennsylvania19111-2497-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
UT Southwestern Medical CenterDallasTexas75390-

Find similar trials in Chapel Hill, NC

By research site
UNC Lineberger Comprehensive Cancer Center· Chapel Hill, NCFox Chase Cancer Center - Philadelphia· Philadelphia, PAThomas Jefferson University Hospital· Philadelphia, PAUT Southwestern Medical Center· Dallas, TX

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