MK-3475/BCG in High Risk Superficial Bladder Cancer

Status Active, not recruiting

Clinical Trial Summary

This is a single center Phase I safety and efficacy study of MK-3475 therapy used in combination with bladder infused BCG treatment for patients, 18 years or older, with high risk superficial bladder cancer (cancer not yet involving the muscle of the bladder wall) who have had removal of their bladder tumor. Patients will be enrolled to a single treatment group of a fixed dose of MK 3475 and BCG.

Clinical Trial Description

Bladder cancer is the fifth most common cancer in the United States. This is a single center Phase I safety and efficacy study of MK-3475 therapy used in combination with bladder infused BCG treatment. The study will determine the safety of administering MK-3475 at a fixed dose every three weeks in conjunction with intravesicular BCG treatment in non-muscle invasive bladder cancer patients who had recurrence after two courses of induction (6 doses) intravesical therapy (two BCG courses, or one BCG course and one other approved intravesical therapies) administered within 12 months, or after one induction (6 doses) and one maintenance (3 doses) intravesical therapy (BCG). Subjects will have confirmation of bladder cancer non-invasive to the muscle. Approximately 20 subjects will be screened to treat 15 eligible subjects with high risk superficial bladder cancer who have had transurethral resection of their bladder tumor. The rationale for the use of the indicated dose of TICE® BCG is based upon FDA approved and commercially provided package insert/ instructions for use of the product. BCG installation has been used to treat non-muscle-invasive bladder cancer for more than 30 years. It is one of the most successful biotherapies for cancer in use. Despite long clinical experience with BCG, the mechanism of its therapeutic effect is still under investigation. The first 3 subjects will be treated at a dose of 100 mg MK-3475 to ensure safety for the combination. If no safety or efficacy issues are present, dosing will be escalated to 200 mg MK-3475 every 3 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02324582
Study type	Interventional
Source	Southern Illinois University
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	June 2015
Completion date	December 30, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

MK-3475/BCG in High Risk Superficial Bladder Cancer — MARC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms