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

Recruiting at34 trial locations

Overseen by Stephen Boorjian, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Ferring Pharmaceuticals

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Stephen Boorjian, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

Aged 18 years or older at the time of 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

Able to give informed consent

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

Suspected hypersensitivity to IFN alfa2b

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

Treatment Details

Interventions

• ADSTILADRIN (=INSTILADRIN) (Virus Therapy)

Participant Groups

Group I: ADSTILADRIN Experimental Treatment 1 Intervention

Intravesical administration of ADSTILADRIN into the bladder

Who Is Running the Clinical Trial?

Ferring Pharmaceuticals

Lead Sponsor

Trials

323

Recruited

1,242,000+

Pierre-Yves Berclaz

Ferring Pharmaceuticals

Chief Medical Officer since 2023

MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine

Jean-Frédéric Paulsen

Ferring Pharmaceuticals

Chief Executive Officer since 2023

Master’s degree in Finance from the London School of Economics and Political Science

FKD Therapies Oy

Industry Sponsor

Trials

2

Recruited

200+

Society of Urologic Oncology Clinical Trials Consortium

Collaborator

Trials

1

Recruited

160+