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Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
1397 patients around the world
Available in Peru
Merck Sharp & Dohme Colombia S.A.S.
2Research sites
1397Patients around the world
This study is for people with
Bladder Cancer
Non-muscle-invasive bladder cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Have locally and blinded independent central review (BICR)-confirmed histological diagnosis of high-risk non-muscle invasive (T1, high grade Ta and/or CIS) UC of the bladderHas undergone cystoscopy/ transurethral resection of bladder tumor (TURBT) to remove all resectable diseaseHas provided tissue for biomarker analysisHas Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2Has adequate organ functionDuring the treatment period and for ≥7 days after the last dose of BCG, male participants are EITHER abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR, must agree to use contraception unless confirmed to be azoospermicFemale 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 a contraception method that is highly effective or remains abstinent from heterosexual intercourse during the treatment period and for ≥7 days after the last dose of BCG or 120 days after the last dose of pembrolizumab, whichever comes lastBCG Post-induction Cohort (Cohort A) Only - Has been treated with one adequate course of BCG induction therapy for the treatment of HR NMIBCBCG Post-induction Cohort (Cohort A) Only - Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC
- Has a history of or concurrent locally advanced (i.e., T2, T3, T4) or metastatic UCHas concurrent extra-vesical (i.e, urethra, ureter, renal pelvis) non-muscle invasive urothelial carcinoma or a history of extra-vesical non-muscle invasive UCHas received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptorHas received prior systemic anti-cancer therapy including investigational agents within 4 weeks of start of study treatmentIs 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 treatmentHas 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 treatmentHas a known additional malignancy that is progressing or requires active treatment within the past 3 yearsHas an active autoimmune disease that has required systemic treatment in past 2 yearsHas a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung diseaseHas 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 BCGHas an active infection or diagnosis requiring systemic antimicrobial therapyHas a known history of human immunodeficiency virus (HIV) infectionHas a known history of Hepatitis B or known active Hepatitis C virus infectionHas current active tuberculosisHas had an allogenic-tissue/solid organ transplantHas any contraindication(s) to IV contrast or is otherwise unable to have screening imaging with IV contrast performedBCG Post-induction Cohort (Cohort A) Only - Has persistent T1 disease following an induction course of BCGBCG Naïve Cohort (Cohort B) Only - Has received any prior treatment with BCG for their NMIBC within the past 2 years prior to study entry
Sites
Clínica Oncosalud
Recruiting
Hospital Militar Central
Recruiting
StudyKEYNOTE-676
SponsorMerck Sharp & Dohme Colombia S.A.S.
Study typeInterventional
Conditions
Non-muscle-invasive bladder cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT03711032
