Clinical Trials /

Study of Pembrolizumab (MK-3475) in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)

NCT02625961

Description:

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.

Related Conditions:
  • Bladder Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Pembrolizumab (MK-3475) in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 3475-057
  • SECONDARY ID: 2014-004026-17
  • NCT ID: NCT02625961

Conditions

  • Bladder Cancer

Interventions

DrugSynonymsArms
pembrolizumabMK-3475Pembrolizumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
PembrolizumabExperimentalParticipants receive pembrolizumab, 200 mg, intravenously, every 3 weeks (Q3W) for up to 24 months.
  • pembrolizumab

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Complete Response Rate
Time Frame:Up to 3 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Duration of Response
Time Frame:Up to 3 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Merck Sharp & Dohme Corp.

Trial Keywords

  • PD1
  • PDL1
  • PD-L1
  • PD-1

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