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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
  • 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
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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: 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
Skyline Urology ( Site 1065)
Torrance, California 90905
United States
Recruiting Study Coordinator
310-602-5005
Woodlands Medical Specialists, PA ( Site 8002)
Pensacola, Florida 32503
United States
Recruiting Study Coordinator
281-863-6778
Rutgers Cancer Institute of New Jersey ( Site 1059)
New Brunswick, New Jersey 08903
United States
Recruiting Study Coordinator
732-235-6048
Texas Oncology-Plano West ( Site 8001)
Plano, Texas 75093
United States
Recruiting Study Coordinator
281-863-6778
Univ. Klinik f. Urologie Innsbruck ( Site 0051)
Innsbruck, 6020
Austria
Recruiting Study Coordinator
+4351250424811
AZ Maria Middelares Gent ( Site 0102)
Gent, 9000
Belgium
Recruiting Study Coordinator
+3292469522
Tampere University Hospital [Tampere Finland] ( Site 0201)
Tampere, 33520
Finland
Recruiting Study Coordinator
+358331164621
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
Akershus University Hospital ( Site 0553)
Lorenskog, 1478
Norway
Recruiting Study Coordinator
+4793200749
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
+349135319207513
Hospital La Fe de Valencia ( Site 0855)
Valencia, 46026
Spain
Recruiting Study Coordinator
+34961244188
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