Clinical Trials /

Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-52)

NCT02335424

Description:

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.

Related Conditions:
  • Bladder Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Study of <span class="go-doc-concept go-doc-intervention">Pembrolizumab (MK-3475)</span> in Participants With Advanced Urothelial Cancer (<span class="go-doc-concept go-doc-intervention">MK-3475</span>-052/KEYNOTE-52)

Title

  • Brief Title: Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-52)
  • Official Title: A Phase II Clinical Trial of Pembrolizumab (MK-3475) in Subjects With Advanced/Unresectable or Metastatic Urothelial Cancer
  • Clinical Trial IDs

    NCT ID: NCT02335424

    ORG ID: 3475-052

    NCI ID: 2014-002206-20

    Trial Conditions

    Urothelial Cancer

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    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.

    Detailed Description

    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.

    Trial Arms

    Name Type Description Interventions
    Pembrolizumab Experimental Participants receive pembrolizumab, 200 mg intravenous (IV) on Day 1 of each 3-week cycle for up to 24 months

    Eligibility Criteria

    Inclusion Criteria:

    - 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

    Exclusion Criteria:

    - 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) for All Participants (Independent Radiology Review)

    ORR by RECIST 1.1 for Participants with PD-L1-positive Tumors (Independent Radiology Review)

    ORR by RECIST 1.1 for Participants with Strongly PD-L1-positive Tumors (Independent Radiology Review)

    Secondary Outcome Measures

    Duration of Response (DOR) by RECIST 1.1 for All Participants, Participants with PD-L1-positive Tumors and Participants with Strongly PD-L1-positive Tumors (Independent Radiology Review)

    Progression-free Survival (PFS) by RECIST 1.1 for All Participants, Participants with PD-L1-positive Tumors and Participants with Strongly PD-L1-positive Tumors (Independent Radiology Review)

    Overall Survival (OS) for All Participants, Participants with PD-L1-positive Tumors and Participants with Strongly PD-L1-positive Tumors

    Trial Keywords

    P-D1

    PD-1

    PD1

    P-DL1

    PD-L1

    PDL-1

    PDL1

    Bladder cancer