CompletedPhase 1

Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer

United States9 participantsStarted 2017-02-10

Plain-language summary

The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerability (the effect of drug on the body) of pembrolizumab, when given as a single agent in patients with bladder tumors. Another purpose of the study is to see what tumor characteristics are associated with increased efficacy of the pembrolizumab. Pembrolizumab (MK-3475) is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body's immune system to work against tumor cells. Pembrolizumab is Food and drug Administration (FDA) approved for the treatment of advanced melanoma (a type of skin cancer) and some types of lung cancer. It is not yet approved by the United States Food and Drug Administration (USFDA) for bladder cancer, hence it is considered an investigational agent for this disease.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have a histologically documented recurrence of non-muscle-invasive bladder carcinoma (T1HG, T1HG after repeat transurethral resection \[reTUR\]) or BCG refractory; if patient has received BCG they can be Ta, Tis, or T1) * Patients must have persistent high grade disease OR be BCG refractory, defined as either: * Recurrence within 6 months of receiving at least 2 courses of intravesical BCG (at least 5 or 6 inductions and at least 2 or 3 maintenance doses) or * T1 high grade disease at the first evaluation following induction BCG alone (at least 5 of 6 induction doses) * Patients must agree to provide tissue from archival biopsy samples or newly obtained excisional biopsy of a tumor lesion * NOTE: Patients who do not have available specimens from previous biopsy or do not agree to provide this tissue are not eligible; cytological specimens will not be acceptable; availability of tissue must be confirmed at the time of registration, but the actual sample does not have to be received in order to complete registration * Patients must have received one course of induction treatment with BCG (4-6 weekly doses), irrespective of the interval since last treatment; patients are allowed to have received any number of prior chemotherapy instillations * NOTE: Patients may have received prior intravesical interferon * All patients must have imaging (computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\]) documenting normal uppe…

What they're measuring

Maximum Tolerated Dose (MTD)

Timeframe: Up to 9 weeks

Trial details

NCT IDNCT02808143

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-15

Results submitted2022-07-27