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Pembrolizumab (MK-3475) as First-line Therapy for High Risk T1 Non-Muscle-Invasive Bladder Cancer

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ClinicalTrials.gov Identifier: NCT03504163
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to find out what effects, good and/or bad, pembrolizumab has on the participant and urothelial cancer.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Pembrolizumab (MK-3475) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a phase II trial of Pembrolizumab (MK-3475) as first-line therapy.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Pembrolizumab (MK-3475) as First-Line Therapy for High Risk T1 Non-Muscle-Invasive Bladder Cancer
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Pembrolizumab (MK-3475)
Patients will receive Pembrolizumab (MK-3475) administered after TUR as single agent initial therapy. Pembrolizumab (MK-3475) will be administered as a 200 mg IV infusion at 3-week intervals for 9 doses over a 24 week period, unless there is unacceptable toxicity or other reasons to discontinue treatment occur.
Drug: Pembrolizumab (MK-3475)
Pembrolizumab (MK-3475) will be administered as a 200 mg IV infusion at 3-week intervals for 9 doses over a 24 week period.




Primary Outcome Measures :
  1. The proportion of patients who are disease-free [ Time Frame: 6 months ]
    Response will be assessed utilizing urine cytology, cystoscopy, and TUR biopsies.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be willing and able to provide written informed consent/assent for the trial.
  • Histologically confirmed urothelial cancer by TURBT performed at MSKCC.
  • TURBT within 6 weeks of protocol entry with complete resection of all papillary lesions.
  • Patients with high risk, BCG-naïve non-muscle-invasive urothelial cancer defined as having one of the following disease states:

    • T1 on restaging biopsy, plus cis
    • Multiple (≥ 1) T1 recurrences, plus cis
    • Multifocal T1 plus cis
    • T1b, plus cis
    • T1 with lymphovascular invasion plus cis
  • Patient refusal of cystectomy and bilateral pelvic lymphadenectomy
  • No prior intravesical therapy.
  • No prior radiation therapy for bladder cancer. Prior radiation therapy for prostate cancer is allowed.
  • ECOG performance status 0 or 1.
  • Age ≥ 18 years of age
  • Female subjects of childbearing potential should be willing to use 2 methods of birth control, be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of the study medication (reference section 9.5.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >1 year.
  • Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
  • Patients must not have other invasive malignancies within the past 5 years (with the exception of non-melanoma skin cancers, localized prostate cancer, and carcinoma in situ of the cervix).
  • Required Initial Laboratory Values:

    • Absolute neutrophil count ≥ 1.5 x 10E9/L
    • Platelets ≥ 100 x 10E9/L
    • Hemoglobin ≥ 9 g/dL
    • Bilirubin ≤ 1.5 times the upper limit of normal (x ULN)
    • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN
    • Calculated creatinine clearance ≥ 30 using the CKD-Epi formula

Exclusion Criteria:

  • Prior treatment with systemic chemotherapy
  • Unstable angina
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction within 6 months
  • History of stroke within 6 months
  • Evidence of bleeding diathesis or coagulopathy
  • Presence of any systemic metastases (ie, nodal, visceral, or central nervous system)
  • Major surgical procedure (other than TURBT) within 28 days prior to the study
  • Pregnant (positive pregnancy test) or lactating
  • Serious, non-healing wound, ulcer, or bone fracture
  • Inability to comply with study and/or follow-up procedures
  • Prior therapy with an anti-PD-1 agent, anti-PD-L1 agent, or other inhibitory or stimulatory agent oriented towards a T-cell receptor
  • Active infection requiring systemic therapy
  • Known history of human immunodeficiency virus (HIV)
  • Known active Hepatitis B or Hepatitis C
  • Received live attenuated vaccines within 30 days prior to start of study treatment. Patients must also agree to avoid live attenuated vaccines during study treatment.
  • Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents. Subjects with vitiligo, diabetes Type I, or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjøgren's syndrome will not be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504163


Contacts
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Contact: Dean Bajorin, MD 646-422-4333 bajorind@mskcc.org
Contact: Guido Dalbagni, MD 646-422-4394

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Dean Bajorin, MD    646-422-4333      
Contact: Guido Dalbagni, MD    646-422-4394      
Principal Investigator: Dean Bajorin, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Dean Bajorin, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03504163     History of Changes
Other Study ID Numbers: 17-602
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Pembrolizumab (MK-3475)
17-602

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents