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 Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)

  • STATUS
    Recruiting
  • End date
    Oct 12, 2028
  • participants needed
    1405
  • sponsor
    Merck Sharp & Dohme LLC
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Updated on 22 October 2022
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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 either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A 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). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

Details
Condition High-risk Non-muscle Invasive Bladder Cancer
Treatment Pembrolizumab, BCG
Clinical Study IdentifierNCT03711032
SponsorMerck Sharp & Dohme LLC
Last Modified on22 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 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 Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Has provided tissue for biomarker analysis
During 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 azoospermic
Has adequate organ function
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 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 last
BCG Post-induction Cohort (Cohort A) Only

Exclusion Criteria

Has a history of or concurrent locally advanced (i.e., T2, T3, T4) or metastatic UC
Has concurrent extra-vesical (i.e, urethra, ureter, renal pelvis) non-muscle invasive urothelial carcinoma or a history of extra-vesical non-muscle invasive UC
Has 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 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 a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has an active infection or diagnosis requiring systemic antimicrobial therapy
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 a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has current active tuberculosis
Has any contraindication(s) to IV contrast or is otherwise unable to have screening imaging with IV contrast performed
BCG Post-induction Cohort (Cohort A) Only - Has persistent T1 disease following an
Has had an allogenic-tissue/solid organ transplant
induction course of BCG
BCG Naïve Cohort (Cohort B) Only
Has received any prior treatment with BCG for their NMIBC within the past 2 years prior
to study entry
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