Bladder Cancer Clinical Trial

ADSTILADRIN (=INSTILADRIN) in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Summary

Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III study is designed to expand those observations using a high dose of ADSTILADRIN in patients that are "BCG Unresponsive" which refers to patients with high-grade NMIBC who are unlikely to benefit from and should not receive further intravesical BCG.

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Full Description

Recombinant IFN alpha2b has pleiotropic effects that contribute to antitumor activity in Non-Muscle Invasive Bladder Cancer (NMIBC). ADSTILADRIN is a non-replicating adenovirus vector harboring the human IFN alpha2b gene. When combined with the excipient Syn3, intravesical administration of the rAd-IFN results in transduction of the virus into the epithelial cell lining in the bladder. The IFN alpha2b gene is incorporated into the cellular DNA resulting in the synthesis and expression of large amounts of IFN alpha2b protein. Clinical studies have confirmed that IFN alpha2b protein can be measured in the urine of patients treated with ADSTILADRIN within 24 hours after dosing.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Aged 18 years or older at the time of consent
Able to give informed consent

Have, at entry, confirmed by a pathology report:

Carcinoma in situ (CIS) only; Ta/T1 high-grade disease with concomitant CIS; or Ta/T1 high-grade disease without concomitant CIS

Are "BCG Unresponsive" which refers to patients with high-grade NMIBC who are unlikely to benefit from and who will not receiving further intravesical BCG. The term "BCG unresponsive" includes patients who did not respond to BCG treatment and have a persistent high-grade recurrence within 12 months after BCG was initiated, and those who despite an initial complete response (CR) to BCG, relapse with high-grade CIS within 12 months of their last intravesical treatment with BCG or relapse with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG. The following criteria define the patients who may be included in the study:

Have received at least 2 previous courses of BCG within a 12 month period - defined as at least 5 of 6 induction BCG instillations and at least 2 out of 3 instillations of maintenance BCG, or at least two of six instillations of a second induction course, where maintenance BCG is not given

Exception: those who have T1 high-grade disease at first evaluation after induction BCG alone (at least 5 of 6 doses) may qualify in the absence of disease progression
At the time of tumor recurrence, patients with CIS alone or high-grade Ta/T1 with CIS should be within 12 months of last exposure to BCG and patients with Ta/T1 without CIS should be within 6 months of last exposure to BCG
No maximum limit to the amount of BCG administered
All visible papillary tumors must be resected and those with persistent T1 disease on transurethral resection of bladder tumor (TURBT) should undergo an additional re-TURBT within 14 to 60 days prior to beginning study treatment. Obvious areas of CIS should also be fulgurated.
Available for the whole duration of the study
Life expectancy >2 years, in the opinion of the investigator
Eastern Cooperative Oncology Group (ECOG) status 2 or less
Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumor by either intravenous pyelogram, retrograde pyelogram, computed tomography (CT) scan with or without urogram, or MRI with or without urogram performed within 6 months of enrollment
Patients with prostate cancer on active surveillance at low risk for progression, defined as Prostate-Specific Antigen (PSA) < 10 ng/dL, Gleason score 6 and clinical stage tumor-1 (cT1) are permitted to be in the study at the discretion of the investigator (see exclusion criterion 10).
Female patients of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for 1 month following the last study drug infusion and must have a negative urine or serum pregnancy test upon entry into this study. Otherwise, female patients must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile. 'Maximally effective birth control' means that the patient, if sexually active, should be using a combination of two methods of birth control that are approved and recognized to be effective by Regulatory Agencies
Male patients must be surgically sterile or willing to use a double barrier contraception method upon enrollment, during the course of the study, and for 1 month following the last study drug infusion
Adequate lab values

Exclusion Criteria:

Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit. Examples that increase the risk of metastatic disease are (but not limited to):

Presence of lymphovascular invasion and/micropapillary disease as shown in the histology of the biopsy sample
Patients with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor
Current systemic therapy for bladder cancer
Current or prior pelvic external beam radiotherapy within 5 years of entry
Prior treatment with adenovirus-based drugs
Suspected hypersensitivity to IFN alfa2b
Symptomatic urinary tract infection or bacterial cystitis (once satisfactorily treated, patients can enter the study)
Clinically significant and unexplained elevated liver or renal function tests
Women who are pregnant or lactating or refuse to commit to use contraception anytime during the study
Any other significant disease or other clinical findings which in the opinion of the investigator would prevent study entry
History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤ pathological tumor-2 (pT2) upper tract urothelial carcinoma at least 24 months after nephroureterectomy. Also patients with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance are excluded (see inclusion criterion 9)
Patients who cannot hold instillation for 1 hour
Patients who cannot tolerate intravesical dosing or intravesical surgical manipulation

Intravesical therapy within 8 weeks prior to beginning study treatment with the exception of:

cytotoxic agents (e.g. Mitomycin C, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure which is permitted between 14 to 60 days prior to beginning study treatment
previous intravesical BCG therapy, which can be given at least 5 weeks before the diagnostic biopsy required for entry into the study

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

157

Study ID:

NCT02773849

Recruitment Status:

Completed

Sponsor:

Ferring Pharmaceuticals

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There are 33 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
Keck School of Medicine at USC Medical Center
Los Angeles California, 90089, United States
The Urology Center of Colorado
Denver Colorado, 80211, United States
University of Florida - UF Health Davis Center Pavilion and Shands Med Plaza
Gainesville Florida, 32610, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
Emory University School of Medicine
Atlanta Georgia, 30322, United States
University of Chicago - Comprehensive Cancer Research Center
Chicago Illinois, 60637, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Johns Hopkins Kimmel Cancer Center
Baltimore Maryland, 21287, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Spectrum Health Medical Group
Grand Rapids Michigan, 49546, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Delaware Valley Urology, LLC
Voorhees New Jersey, 08043, United States
Montefiore Medical Center
Bronx New York, 10461, United States
SUNY Upstate Medical Center
Syracuse New York, 13210, United States
University of North Carolina (UNC) - Chapel Hill
Chapel Hill North Carolina, 27599, United States
Duke University
Durham North Carolina, 27710, United States
The University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
The Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Regional Urology
Greenville South Carolina, 29605, United States
Carolina Urologic research Center
Myrtle Beach South Carolina, 29572, United States
Vanderbilt University Medical Center Dept. of Urologic Surgery
Nashville Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Baylor College of Medicine
Houston Texas, 77030, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
The Univ. of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
University of Virginia Health System
Charlottesville Virginia, 22908, United States
Urology of Virginia
Virginia Beach Virginia, 23462, United States
West Virginia University Cancer Institute
Morgantown West Virginia, 26506, United States
University of Wisconsin - Madison
Madison Wisconsin, 53705, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

157

Study ID:

NCT02773849

Recruitment Status:

Completed

Sponsor:


Ferring Pharmaceuticals

How clear is this clinincal trial information?

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