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Brief Title: Study of Pembrolizumab (MK-3475) in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)

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

INTRODUCTION

  • Org Study ID: 3475-057
  • Secondary ID: N/A
  • NCT ID: NCT02625961
  • Sponsor: Merck Sharp & Dohme LLC

BRIEF SUMMARY

In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for or have refused to undergo radical cystectomy, will receive pembrolizumab therapy or pembrolizumab in combination with other investigational agents. The primary study hypothesis is that treatment with pembrolizumab will result in a clinically meaningful response.

  • Overall Status
    Recruiting
  • Start Date
    February 10, 2016
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Complete Response Rate

Primary Outcome 1 - Timeframe: Up to 3 years

Primary Outcome 2 - Measure: Disease Free Survival Rate

Primary Outcome 2 - Timeframe: Up to approximately 12 months

Primary Outcome 3 - Measure: 12-month Complete Response Rate

Primary Outcome 3 - Timeframe: Up to approximately 12 months

CONDITION

  • Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
* Histologically-confirmed diagnosis of high risk non-muscle-invasive (T1, high grade Ta and / or carcinoma in situ [CIS]) transitional cell carcinoma of the bladder (mixed histology tumors allowed if transitional cell histology is predominant histology).

- * Fully resected disease at study entry (residual CIS acceptable)

- * BCG-unresponsive high risk non-muscle-invasive bladder cancer after treatment with adequate BCG therapy

- * Ineligible for radical cystectomy or refusal of radical cystectomy

- * Available tissue from a newly obtained core biopsy of a tumor lesion not previously irradiated

- * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- * 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
Exclusion criteria:
* Centrally assessed muscle-invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (i.e., T2, T3, T4, and / or stage IV)

- * Centrally assessed 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme LLC

Overall Contact

Name: Medical Director

Phone: 1-888-577-8839

Email: N/A

LOCATION

Facility Status Contact
Facility: Call for Information (Investigational Site 0023)
Minneapolis, Minnesota 55455
United States
Status: Recruiting Contact: N/A
Facility: Call for Information (Investigational Site 0002)
Hackensack, New Jersey 07601
United States
Status: Recruiting Contact: N/A
Facility: Call for Information (Investigational Site 0018)
New Brunswick, New Jersey 08901
United States
Status: Recruiting Contact: N/A
Facility: Call for Information (Investigational Site 0072)
Cincinnati, Ohio 45212
United States
Status: Recruiting Contact: N/A
Facility: Call for Information (Investigational Site 0009)
Cleveland, Ohio 44106
United States
Status: Recruiting Contact: N/A
Facility: Call for Information (Investigational Site 0074)
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: N/A
Facility: Call for Information (Investigational Site 0078)
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: N/A
Facility: MSD Australia
North Ryde,
Australia
Status: Recruiting Contact: Contact
Australian Medical Information Centre
61 2 8988 8428

Facility: Merck Canada
Kirkland, Quebec H9H 4M7
Canada
Status: Recruiting Contact: Contact
Medical Information Centre Centre d'information medicale Merck Canada Inc.
514-428-8600 / 1-800-567-2594

Facility: MSD Finland Oy
Espoo,
Finland
Status: Recruiting Contact: Contact
Michael Pasternack
358 20 7570300

Facility: MSD France
Paris,
France
Status: Recruiting Contact: Contact
Dominique Blazy
33 147548990

Facility: MSD Italia S.r.l.
Rome,
Italy
Status: Recruiting Contact: Contact
Barbara Capaccetti
39 06361911

Facility: Merck Sharp & Dohme BV
Haarlem,
Netherlands
Status: Recruiting Contact: Contact
Caroline Doornebos
31 23 515 3362

Facility: Call for Information (Investigational Site 2402)
Ponce, 00717
Puerto Rico
Status: Recruiting Contact: N/A
Facility: Call for Information (Investigational Site 2400)
Rio Piedras, 00935
Puerto Rico
Status: Recruiting Contact: N/A
Facility: Merck Sharp & Dohme (I.A.) Corp
Singapore,
Singapore
Status: Recruiting Contact: Contact
Cesar Recto
632 784 9500

Facility: Merck Sharp and Dohme de Espana S.A.
Madrid,
Spain
Status: Recruiting Contact: Contact
Lourdes Lopez-Bravo
(0034) 913210654

Facility: Merck Sharp & Dohme Ilaclari Ltd. Sti
Istanbul,
Turkey
Status: Recruiting Contact: Contact
Alev Eren
90 212 336 12 63