Back to Clinical Trials

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

Phase II Study of Pembrolizumab (MK-3475) as First-Line Therapy for High Risk T1 Non-Muscle-Invasive Bladder Cancer

INTRODUCTION

  • Org Study ID: 17-602
  • Secondary ID: N/A
  • NTC ID: NCT03504163
  • Sponsor: Memorial Sloan Kettering Cancer Center
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.

  • Overall Status
    Recruiting
  • Start Date
    June 27, 2018
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: The proportion of patients who are disease-free

Primary Outcome 1 - Timeframe: 6 months

CONDITION

  • Bladder Cancer

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Dean Bajorin, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Dean Bajorin, MD

Phone: 646-888-4700, 646-422-4394

Email: bajorind@mskcc.org

LOCATION

Facility Status Contact
Facility: Memoral Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey 10065
United States
Status: Recruiting Contact: Contact
Dean Bajorin, MD
646-888-4700
Facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey 07748
United States
Status: Recruiting Contact: Contact
Dean Bajorin, MD
646-888-4700
Facility: Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey 07645
United States
Status: Recruiting Contact: Contact
Dean Bajorin, MD
646-888-4700
Facility: Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York 11725
United States
Status: Recruiting Contact: Contact
Dean Bajorin, MD
646-888-4700
Facility: Memorial Sloan Kettering West Harrison (All Protocol Activities)
Harrison, New York 10604
United States
Status: Recruiting Contact: Contact
Dean Bajorin, MD
646-888-4700
Facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Dean Bajorin, MD
646-888-4700
Facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York 11553
United States
Status: Recruiting Contact: Contact
Guido Dalbagni, MD
646-422-4394