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BRIEF TITLE: Efficacy and Safety of Pembrolizumab (MK-3475) in Subjects With High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy

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


  • Org Study ID: 3475-057
  • Secondary ID: 2014-004026-17
  • NCT ID: NCT02625961
  • NCT Alias:
  • Sponsor: Merck Sharp & Dohme Corp. - Industry
  • Source: Merck Sharp & Dohme Corp.

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. The primary study hypothesis is that treatment with pembrolizumab will result in a clinically meaningful response.

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

Primary Outcomes:

Primary Outcome 1 - Measure: Complete Response Rate

Primary Outcome 1 - Time Frame: Up to 3 years

Primary Outcome 2 - Measure: Disease Free Survival Rate

Primary Outcome 2 - Time Frame: Up to 3 years

Condition:

  • Bladder Cancer

Eligibility

Criteria:
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:

- Muscle-invasive, locally advanced nonresectable, or metastatic urothelial carcinoma
(i.e., T2, T3, T4, and / or stage IV)

- 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
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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 Corp.

Overall Contact

Name: Toll Free Number

Phone: 1-888-577-8839

Email:

Locations

Facility Status Contact
Call for Information (Investigational Site 0022)
Duarte, California 91010
United States
Recruiting
Call for Information (Investigational Site 0017)
Los Angeles, California 90048
United States
Recruiting
Call for Information (Investigational Site 0021)
Orange, California 92868
United States
Recruiting
Call for Information (Investigational Site 0032)
Santa Monica, California 90404
United States
Recruiting
Call for Information (Investigational Site 0077)
Hanover, Maryland 21076
United States
Recruiting
Call for Information (Investigational Site 0026)
Boston, Massachusetts 02115
United States
Recruiting
Call for Information (Investigational Site 0034)
Detroit, Michigan 48202
United States
Recruiting
Call for Information (Investigational Site 0023)
Minneapolis, Minnesota 55455
United States
Recruiting
Call for Information (Investigational Site 0096)
Las Vegas, Nevada 89148
United States
Recruiting
Call for Information (Investigational Site 0002)
Hackensack, New Jersey 07601
United States
Recruiting
Call for Information (Investigational Site 0018)
New Brunswick, New Jersey 08903
United States
Recruiting
Call for Information (Investigational Site 0073)
Voorhees, New Jersey 08043
United States
Recruiting
Call for Information (Investigational Site 0035)
Lake Success, New York 11042-1133
United States
Recruiting
Call for Information (Investigational Site 0004)
New York, New York 10016
United States
Recruiting
Call for Information (Investigational Site 0025)
New York, New York 10065
United States
Recruiting
Call for Information (Investigational Site 0076)
Syracuse, New York 13210
United States
Recruiting
Call for Information (Investigational Site 0072)
Cincinnati, Ohio 45212
United States
Recruiting
Call for Information (Investigational Site 0009)
Cleveland, Ohio 44106
United States
Recruiting
Call for Information (Investigational Site 0074)
Bala-Cynwyd, Pennsylvania 19004
United States
Recruiting
Call for Information (Investigational Site 0008)
Pittsburgh, Pennsylvania 15232
United States
Recruiting
Call for Information (Investigational Site 0078)
Myrtle Beach, South Carolina 29572
United States
Recruiting
Call for Information (Investigational Site 0092)
Houston, Texas 77024
United States
Recruiting
Call for Information (Investigational Site 0003)
Salt Lake City, Utah 84112
United States
Recruiting
Call for Information (Investigational Site 0079)
Virginia Beach, Virginia 23462
United States
Recruiting
Call for Information (Investigational Site 0031)
Seattle, Washington 98109
United States
Recruiting
Merck Sharp & Dohme
North Ryde,
Australia
Recruiting Australian Medical Information Centre
61 2 8988 8428
MSD Brasil
Sao Paulo,
Brazil
Recruiting MSD Online
0800 012 22 32
Merck Canada
Kirkland, Quebec H9H 4M7
Canada
Recruiting Medical Information Centre Centre d'information medicale Merck Canada Inc.
514-428-8600 / 1-800-567-2594
MSD Finland Oy
Espoo,
Finland
Recruiting Katrin Moeschlin
460857813500
MSD France
Paris,
France
Recruiting Valerie Bouchara
33 180464417
Vianex, S.A. / MSD
Alimos,
Greece
Recruiting Anna Aletra
30 2109897318
MSD Italia S.r.l.
Rome,
Italy
Recruiting Paola Chiaretta Fattore
39 0636191739
MSD K.K.
Chiyoda-Ku, Tokyo, 102-8667
Japan
Recruiting Japan Call Center
81-3-6272-1957
MSD Korea LTD
Seoul, 4130
Korea, Republic of
Recruiting TaeYoun Jo
8223312313
Merck Sharp & Dohme BV
Haarlem,
Netherlands
Recruiting Arjan Ooms
31235153306
Merck Sharp & Dohme IDEA, Inc.
Moscow,
Russian Federation
Recruiting Tatiana Serebriakova
74959167100, EXT.366
MSD Sweden
Stockholm,
Sweden
Recruiting Katrin Moeschlin
46857813545
Merck Sharp & Dohme Ilaclari Ltd. Sti
Istanbul,
Turkey
Recruiting Betul Erdogan
2123361232
Merck Sharp & Dohme Ltd.
Hoddesdon,
United Kingdom
Recruiting Paul Duffy
44 01992455265