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BRIEF TITLE: A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Persistent or Recurrent Following BCG Induction (KEYNOTE-676)

A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Persistent or Recurrent Following BCG Induction (KEYNOTE-676)


  • Org Study ID: 3475-676
  • Secondary ID: MK-3475-676,2018-001967-22,194713
  • NCT ID: NCT03711032
  • NCT Alias:
  • Sponsor: Merck Sharp & Dohme Corp. - Industry
  • Source: Merck Sharp & Dohme Corp.

Brief Summary

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is persistent or recurrent following adequate BCG induction. The primary hypothesis is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS).

Overal Status Start Date Phase Study Type
Recruiting December 24, 2018 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Complete Response Rate (CRR) by Blinded Independent Central Review (BICR)

Primary Outcome 1 - Time Frame: Up to ~3.5 years

Condition:

  • High-risk Non-muscle Invasive Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Has histologically-confirmed diagnosis of non-muscle invasive (T1, high grade Ta
and/or CIS) transitional cell carcinoma (TCC) of the bladder

- Has been treated with one adequate course of BCG induction therapy for the treatment
of HR NMIBC

- Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC

- Has undergone cystoscopy/ transurethral resection of bladder tumor (TURBT) to remove
all resectable disease

- Has provided tissue for biomarker analysis

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

- Has adequate organ function

- Male participants must agree to use approved contraception during the treatment period
and for at least 120 days after the last dose of study treatment and refrain from
donating sperm during this period

- Female participants who are not pregnant, not breastfeeding, and either not a woman of
child bearing potential (WOCBP) or are a WOCBP who agrees to use approved
contraception during the treatment period and for at least 120 days after the last
dose of study treatment

Exclusion Criteria:

- Has persistent T1 disease following an induction course of BCG

- Has muscle invasive (i.e., T2, T3, T4), locally advanced non-resectable or metastatic
UC

- Has concurrent extra-vesical (i.e., urethra, ureter, renal pelvis) non-muscle invasive
TCC of the urothelium, concurrent upper tract involvement, or invasive prostatic TCC
including T1 or greater disease, or ductal invasion

- WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization

- Has received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an
agent directed to another co-inhibitory T-cell receptor

- Has received prior systemic anti-cancer therapy including investigational agents
within 4 weeks of start of study treatment

- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks of start of study treatment

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
or any other form of immunosuppressive therapy within 7 days of start of study
treatment

- Has a known additional malignancy that is progressing or requires active treatment
within the past 3 years

- Has an active autoimmune disease that has required systemic treatment in past 2 years

- Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis

- Has one or more of the following contraindications to BCG: prior BCG sepsis or
systemic infection, total bladder incontinence, or an adverse experience to a previous
BCG instillation that resulted in treatment discontinuation and precludes retreating
with BCG

- Has an active infection requiring systemic therapy

- Has a known history of human immunodeficiency virus (HIV) infection

- Has a known history of Hepatitis B or known active Hepatitis C virus infection

- Has evidence of active tuberculosis

- Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 120 days
after the last dose of trial treatment
Show More

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: Trialsites@merck.com

Locations

Facility Status Contact
Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083)
Anchorage, Alaska 99503
United States
Recruiting Study Coordinator
907-276-1455
UCLA ( Site 1052)
Los Angeles, California 90095
United States
Recruiting Study Coordinator
310-794-3421
University of California Irvine Medical Center ( Site 1061)
Orange, California 92868
United States
Recruiting Study Coordinator
714-456-8148
Skyline Urology ( Site 1065)
Torrance, California 90905
United States
Recruiting Study Coordinator
310-602-5005
Sylvester Comprehensive Cancer Center ( Site 1056)
Miami, Florida 33136
United States
Recruiting Study Coordinator
305-243-2177
Woodlands Medical Specialists, PA ( Site 8002)
Pensacola, Florida 32503
United States
Recruiting Study Coordinator
281-863-6778
Emory University ( Site 1076)
Atlanta, Georgia 30322
United States
Recruiting Study Coordinator
404-778-4823
Wichita Urology Group ( Site 1086)
Wichita, Kansas 67226
United States
Recruiting Study Coordinator
316-636-6141
Michigan Institute of Urology ( Site 1077)
Troy, Michigan 48084
United States
Recruiting Study Coordinator
248-786-0467
Coastal Urology Associates ( Site 1055)
Brick, New Jersey 08724
United States
Recruiting Study Coordinator
732-840-4300
Rutgers Cancer Institute of New Jersey ( Site 1059)
New Brunswick, New Jersey 08903
United States
Recruiting Study Coordinator
732-235-6048
St. Peter's Hospital Cancer Care Center ( Site 1087)
Albany, New York 12208
United States
Recruiting Study Coordinator
518-438-1019
Northwell Health- Monter Cancer Center ( Site 1080)
Lake Success, New York 11042
United States
Recruiting Study Coordinator
516-734-8500
Associated Medical Professionals of NY ( Site 1078)
Syracuse, New York 13210
United States
Recruiting Study Coordinator
31547841857794
Tri-State Urologic Services PSC, Inc. ( Site 1091)
Cincinnati, Ohio 45212
United States
Recruiting Study Coordinator
000-000-0000
MidLantic Urology ( Site 1071)
Bala-Cynwyd, Pennsylvania 19004
United States
Recruiting Study Coordinator
610-667-0458
Lancaster Urology ( Site 1079)
Lancaster, Pennsylvania 17604
United States
Recruiting Study Coordinator
717-431-2285
University of Pennsylvania ( Site 1088)
Philadelphia, Pennsylvania 19104
United States
Recruiting Study Coordinator
215-662-2891
Carolina Urologic Research Center ( Site 1085)
Myrtle Beach, South Carolina 29572
United States
Recruiting Study Coordinator
8434491010257
Urology Associates [Nashville, TN] ( Site 1072)
Nashville, Tennessee 37209
United States
Recruiting Study Coordinator
615-250-9268
Texas Oncology - Fort Worth Cancer Center ( Site 8003)
Fort Worth, Texas 76104
United States
Recruiting Study Coordinator
281-863-6778
Texas Oncology-Plano West ( Site 8001)
Plano, Texas 75093
United States
Recruiting Study Coordinator
281-863-6778
University of Vermont Medical Center ( Site 1057)
Burlington, Vermont 05401
United States
Recruiting Study Coordinator
802-656-9926
Urology of Virginia ( Site 1070)
Virginia Beach, Virginia 23462
United States
Recruiting Study Coordinator
757-452-3463
Sydney Adventist Hospital ( Site 0001)
Wahroonga, New South Wales (Australia) 2076
Australia
Completed
Nothern Cancer Institute ( Site 0003)
St Leonards, New South Wales 2065
Australia
Completed
Univ. Klinik f. Urologie Innsbruck ( Site 0051)
Innsbruck, 6020
Austria
Recruiting Study Coordinator
+435050424811
Ordensklinikum Linz GmbH Elisabethinen ( Site 0052)
Linz, 4020
Austria
Recruiting Study Coordinator
+4373276777727
O.L.V. Ziekenhuis Aalst ( Site 0106)
Aalst, 9300
Belgium
Recruiting Study Coordinator
+3253724378
AZ Maria Middelares Gent ( Site 0102)
Gent, 9000
Belgium
Recruiting Study Coordinator
+3292469522
Universitair Ziekenhuis Gent ( Site 0101)
Gent, 9000
Belgium
Recruiting Study Coordinator
+3293322811
CHU UCL Namur Site de Godinne ( Site 0103)
Yvoir, 5530
Belgium
Recruiting Study Coordinator
+3281423858
Exdeo Clinical Research Inc. ( Site 0165)
Abbotsford, British Columbia V2T 1X8
Canada
Recruiting Study Coordinator
6048515667
Horizon Health Network ( Site 0160)
Moncton, New Brunswick E1C 6Z8
Canada
Recruiting Study Coordinator
5068574780
Princess Margaret Cancer Centre ( Site 0153)
Toronto, Ontario M5G 2M9
Canada
Recruiting Study Coordinator
4169462246
CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)
Chicoutimi, Quebec G7H 5H6
Canada
Recruiting Study Coordinator
4185411000
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157)
Montreal, Quebec H1T 2M4
Canada
Recruiting Study Coordinator
51425234005853
CHUS - Hopital Fleurimont ( Site 0152)
Sherbrooke, Quebec J1H 5N4
Canada
Recruiting Study Coordinator
819346111012852
CHU de Quebec - Hotel-Dieu de Quebec ( Site 0151)
Quebec, G1R 2J6
Canada
Recruiting Study Coordinator
418525444420414
Tampere University Hospital [Tampere Finland] ( Site 0201)
Tampere, 33520
Finland
Recruiting Study Coordinator
+358331164621
Universitaetsklinikum Jena ( Site 0252)
Jena, 07747
Germany
Recruiting Study Coordinator
+491711421827
Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266)
Munich, 81675
Germany
Recruiting Study Coordinator
+498941402522
Krankenhaus der Barmherzigen Brueder Trier ( Site 0262)
Trier, 54292
Germany
Recruiting Study Coordinator
+496512082680
Klinikum Weiden ( Site 0259)
Weiden In Der Oberpfalz, 92637
Germany
Recruiting Study Coordinator
+49963033302
Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303)
Thessaloniki, 540 07
Greece
Recruiting Study Coordinator
+302310898721
Ospedale San Martino ( Site 0351)
Genova, GE 16132
Italy
Recruiting Study Coordinator
+390105552233
Istituto Tumori Giovanni Paolo II ( Site 0357)
Bari, 70124
Italy
Recruiting Study Coordinator
+390805555420
Osp Generale Reg di Bolzano ( Site 0355)
Bolzano, 39100
Italy
Recruiting Study Coordinator
+393477835206
Azienda Ospedaliero Universitaria Careggi ( Site 0360)
Firenze, 50134
Italy
Recruiting Study Coordinator
+390552758011
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353)
Milan, 20133
Italy
Recruiting Study Coordinator
+390223902402
Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352)
Palermo, 90123
Italy
Recruiting Study Coordinator
+39091479432
A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356)
Verona, 37126
Italy
Recruiting Study Coordinator
+390458123876
Ehime University Hospital ( Site 0414)
Toon, Ehime 791-0295
Japan
Recruiting Study Coordinator
+81899645111
Kitasato University Hospital ( Site 0403)
Sagamihara, Kanagawa 252-0375
Japan
Recruiting Study Coordinator
+81427788111
Yokosuka Kyosai Hospital ( Site 0406)
Yokosuka, Kanagawa 238-8558
Japan
Recruiting Study Coordinator
+81468222710
Nara Medical University Hospital ( Site 0411)
Kashihara, Nara 634-8522
Japan
Recruiting Study Coordinator
+81744223051
Chiba Cancer Center ( Site 0401)
Chiba, 260-8717
Japan
Recruiting Study Coordinator
+81432645431
Harasanshin Hospital ( Site 0410)
Fukuoka, 812-0033
Japan
Recruiting Study Coordinator
+81922913434
Osaka International Cancer Institute ( Site 0413)
Osaka, 541-8567
Japan
Recruiting Study Coordinator
+81669451181
Osaka City University Hospital ( Site 0404)
Osaka, 545-8586
Japan
Recruiting Study Coordinator
+81666452121
Medical Hospital, Tokyo Medical And Dental University ( Site 0409)
Tokyo, 113-8519
Japan
Recruiting Study Coordinator
+81338136111
Keio University Hospital ( Site 0405)
Tokyo, 160-8582
Japan
Recruiting Study Coordinator
+81333531211
Korea University Anam Hospital ( Site 0801)
Seoul, 02841
Korea, Republic of
Recruiting Study Coordinator
+821099288097
Seoul National University Hospital ( Site 0802)
Seoul, 03080
Korea, Republic of
Recruiting Study Coordinator
+821036400506
Asan Medical Center ( Site 0804)
Seoul, 05505
Korea, Republic of
Recruiting Study Coordinator
+82230103980
Samsung Medical Center ( Site 0803)
Seoul, 06351
Korea, Republic of
Recruiting Study Coordinator
+82234103557
University Malaya Medical Centre ( Site 1180)
Kuala Lumpur, 59100
Malaysia
Recruiting Study Coordinator
+60379492120
Erasmus MC ( Site 0451)
Rotterdam, 3015 GD
Netherlands
Recruiting Study Coordinator
+31107041505
Akershus University Hospital ( Site 0553)
Lorenskog, 1478
Norway
Recruiting Study Coordinator
+4793200749
Stavanger universitetssykehus ( Site 0555)
Stavanger, 4011
Norway
Recruiting Study Coordinator
+4798444505
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601)
La Victoria, Lima 15033
Peru
Recruiting Study Coordinator
+51999437977
Oncosalud ( Site 0603)
Lima, 15036
Peru
Recruiting Study Coordinator
+51992756559
Hospital Militar Central [Lima, Peru] ( Site 0604)
Lima, 15076
Peru
Recruiting Study Coordinator
+51997468543
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0671)
Koscierzyna, 83-400
Poland
Recruiting Study Coordinator
+48607460282
LIFTMED ( Site 0652)
Rybnik, 44-200
Poland
Recruiting Study Coordinator
+48508278250
Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654)
Siedlce, 08-110
Poland
Recruiting Study Coordinator
+48504283093
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655)
Slupsk, 76-200
Poland
Recruiting Study Coordinator
+48598460340
Magodent Szpital Elblaska ( Site 0653)
Warszawa, 01-748
Poland
Recruiting Study Coordinator
+48691666578
Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669)
Wroclaw, 50-556
Poland
Recruiting Study Coordinator
+48601143281
2CA Braga. Centro Clinico Academico ( Site 0705)
Braga, 4710-243
Portugal
Recruiting Study Coordinator
+351253027249
Inst. Portugues de Oncologia de Coimbra Francisco Gentil EPE ( Site 0704)
Coimbra, 3000-075
Portugal
Recruiting Study Coordinator
+351239400200
CHLN Hospital Santa Maria ( Site 0702)
Lisboa, 1649-035
Portugal
Recruiting Study Coordinator
+351217805056
Hospital CUF Descobertas ( Site 0706)
Lisboa, 1998-018
Portugal
Recruiting Study Coordinator
+351210025200
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701)
Porto, 4200-072
Portugal
Recruiting Study Coordinator
+351225084000
Hospital Universitario Quiron Madrid ( Site 0862)
Pozuelo de Alarcon, Madrid 28223
Spain
Recruiting Study Coordinator
+34914521987
Clinica Universitaria de Navarra ( Site 0863)
Pamplona, Navarra 31008
Spain
Recruiting Study Coordinator
+34913531920ext7513
Hospital Universitario Lucus Augusti ( Site 0852)
Lugo, 27003
Spain
Recruiting Study Coordinator
+34982296459
Hospital Universitario Gregorio Maranon ( Site 0854)
Madrid, 28007
Spain
Recruiting Study Coordinator
+34914269070
Clinica Universitaria Navarra - Madrid ( Site 0860)
Madrid, 28027
Spain
Recruiting Study Coordinator
+34913531920ext7513
MD Anderson Cancer Center Madrid ( Site 0859)
Madrid, 28033
Spain
Recruiting Study Coordinator
+34917878600
Hospital Universitario Ramon y Cajal ( Site 0857)
Madrid, 28034
Spain
Recruiting Study Coordinator
+34913368263
Hospital La Fe de Valencia ( Site 0855)
Valencia, 46026
Spain
Recruiting Study Coordinator
+34961244188
Universitaetsspital Basel ( Site 1201)
Basel, 4031
Switzerland
Recruiting Study Coordinator
+41615565477
Hopitaux Universitaires de Geneve HUG ( Site 1204)
Geneve, 1211
Switzerland
Recruiting Study Coordinator
+41795532381
Universitaetsspital Zurich ( Site 1203)
Zurich, 8091
Switzerland
Recruiting Study Coordinator
+41442555440
Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953)
Eskisehir, 26480
Turkey
Recruiting Study Coordinator
+905327149696
Dokuz Eylul Universitesi ( Site 0959)
Izmir, 35340
Turkey
Recruiting Study Coordinator
+905055250505
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961)
Konya, 42000
Turkey
Recruiting Study Coordinator
+905322679838
Raigmore Hospital ( Site 1006)
Inverness, Highland IV2 3UJ
United Kingdom
Recruiting Study Coordinator
+4401463706356
St Georges University Hospitals NHS Foundation Trust. ( Site 1005)
London, Tooting SW17 0QT
United Kingdom
Recruiting Study Coordinator
+442087253362