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A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination with Other Investigational Agents in Subjects with High-risk Non-muscle-Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy

Pembrolizumab (MK-3475), and pembrolizumab in combination with other investigational agents in high-risk NMIBC patients unresponsive to BCG

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12, Kudan-kita, Chiyoda-ku, Tokyo

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSDKK

KITANOMARU SQUARE, 1-13-12, Kudan-kita, Chiyoda-ku, Tokyo

+81-3-6272-1957

msdjrct@msd.com

completed

Aug. 25, 2016

Interventional

Single Group Assignment

treatment purpose

2

- Have a histologically-confirmed diagnosis of high-risk non-muscle-invasive (T1, High Grade Ta and/or CIS) transitional cell carcinoma of the bladder. Subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology.
- Fully resected disease at study entry (residual CIS acceptable).
- Have been treated with adequate BCG therapy and have developed high-risk NMIBC that is unresponsive to BCG therapy.
- Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.
- Have provided tissue for biomarker analysis from the most recent cystoscopy/TURBT procedures from which tumor sample is available.
- Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Have adequate organ function.
- Female participants of childbearing potential have a negative urine or serum pregnancy test and must be willing to use an adequate method of contraception.
- Male participants must be willing to use an adequate method of contraception.

- Has muscle-invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (i.e., T2, T3, T4, and / or stage IV).
- Has concurrent extra-vesical (i.e., urethra, ureter, or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
- Currently participating or has participated in a study of an investigational agent and received study therapy or received investigational device within 4 weeks prior to the first dose of study treatment.
- Received intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy / Transurethral Resection of Bladder Tumor (TURBT) to starting study treatment.
- Received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment or not recovered from adverse events due to a previously administered agent.
- Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable provided that the following criteria are met: Stage T2N0M0 or lower; Gleason score <=7 and prostatic-specific antigen (PSA) undetectable for at least 1 year while off androgen deprivation therapy that was either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocation.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- Evidence of interstitial lung disease or active non-infectious pneumonitis.
- Active infection requiring systemic therapy.
- Pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial through 120 days after the last dose of study treatment.
- Prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor.
- Known human immunodeficiency virus (HIV).
- Known active Hepatitis B or C infection.
- Received a live virus vaccine within 30 days of planned start of study treatment.
- Has had an allogeneic tissue/solid organ transplant.

Both

High-risk Non-muscle-Invasive Bladder Cancer

Investigational material(s)
Generic name etc : MK-3475
INN of investigational material : Pembrolizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Participants receive pembrolizumab 200mg via IV infusion once every 3 weeks for up to 35 administrations

Complete Response Rate
Disease Free Survival Rate at 12-months

Duration of Response

+81-92-291-3434

Dec. 17, 2015