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Eligibility
for people ages 18 years and up
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. The primary study objective is to determine the objective response rate (ORR) in all participants, in participants whose tumors rely on programmed cell death ligand 1 (PD-L1) protein (PD-L1-positive tumors), and in participants with strongly PD-L1-positive tumors.

Official Title

A Phase II Clinical Trial of Pembrolizumab (MK-3475) in Subjects With Advanced/Unresectable or Metastatic Urothelial Cancer

Details

Participants receiving pembrolizumab who attain a complete response (CR) may consider stopping trial treatment if they meet criteria for holding therapy. Participants who stop trial treatment after receiving 24 months of trial treatment for reasons other than progressive disease (PD) or intolerability, or participants who attain a CR and stop trial treatment may be eligible for up to one year of retreatment upon experiencing PD.

Keywords

Urothelial Cancer P-D1 PD-1 PD1 P-DL1 PD-L1 PDL-1 PDL1 Bladder cancer Pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically- or cytologically-confirmed diagnosis of advanced/unresectable(inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell and mixed transitional/non-transitional cell histologies)
  • Ineligible for cisplatin therapy
  • No prior systemic chemotherapy for metastatic disease (adjuvant or neoadjuvant platinum-based chemotherapy with recurrence>12 months since completion of therapy is allowed)
  • Available tissue from a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Measureable disease
  • 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; surgically sterile, or willing to use 2 acceptable methods of birth control, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment
  • Male participants must be willing to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study treatment

You CAN'T join if...

  • Disease that is suitable for local therapy administered with curative intent
  • Currently participating or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study treatment
  • Prior anti-cancer monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from AEs 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 cancer
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active autoimmune disease that has required systemic treatment in 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 or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study treatment
  • Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-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
  • Received a live virus vaccine within 30 days of planned start of study treatment

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme Corp.
ID
NCT02335424
Phase
Phase 2
Lead Scientist
Lawrence Fong
Study Type
Interventional
Last Updated
March 1, 2017