A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (MK-3475-061/KEYNOTE-061)



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/19/2016
Start Date:May 2015
End Date:December 2017
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine

This is a study for participants with advanced gastric or gastroesophageal junction
adenocarcinoma who have had tumor progression after first-line treatment with platinum and
fluoropyrimidine doublet therapy. The primary study hypotheses are that pembrolizumab
prolongs progression free survival (PFS) and overall survival (OS) for participants with
tumors that show positive programmed cell death ligand 1 (PD-L1) expression.


Inclusion Criteria:

- Have histologically- or cytologically-confirmed diagnosis of gastric or
gastroesophageal junction adenocarcinoma

- Confirmed metastatic or locally advanced, unresectable disease (by CT scan or
clinical evidence)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Progression on or after prior first-line therapy containing any
platinum/fluoropyrimidine doublet

- Willing to provide tumor tissue for PD-L1 biomarker analysis (new or archived
specimens with agreement of Sponsor)

- HER-2/neu status known and participants with HER2/neu positive tumors show
documentation of disease progression on treatment containing trastuzumab

- Female participants of childbearing potential should be willing to use 2 methods of
birth control or be surgically sterile, or abstain from heterosexual activity for the
course of the study through 120 days after the last dose of pembrolizumab or through
180 days after the last dose of paclitaxel.

- Male participants 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
pembrolizumab or through 180 days after the last dose of paclitaxel.

- Adequate organ function

Exclusion Criteria:

- Currently participating and receiving study therapy, or participated in a study of an
investigational agent and received study therapy or used an investigation device
within 4 weeks of the first dose of medication

- Squamous cell or undifferentiated gastric cancer

- Active autoimmune disease that has required systemic treatment in past 2 years
(replacement therapy is not considered a form of systemic treatment

- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
of immunosuppressive therapy within 7 days prior to the first dose of study
medication

- Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or
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 adverse events due to a previously
administered agent or surgery

- Known additional malignancy that is progressing or requires active treatment (with
the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the
skin, or in situ cervical cancer that has undergone potentially curative therapy)

- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

- History or evidence of interstitial lung disease or active non-infectious pneumonitis

- Active infection requiring systemic therapy

- Known psychiatric or substance abuse disorders that would interfere with cooperation
with the requirements of the trial

- 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 pembrolizumab or through 180 days after the last dose of
paclitaxel.

- Prior immunotherapy including anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or
previously participated in Merck pembrolizumab (MK-3475) clinical trial

- Known history of human immunodeficiency virus (HIV)

- Known active Hepatitis B or Hepatitis C

- Live vaccine within 30 days of planned start of study therapy

- Known allergy or hypersensitivity to paclitaxel or any components used in the
paclitaxel preparation or other contraindication for taxane therapy
We found this trial at
20
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Arlington Heights, Illinois 60004
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Buenos Aires,
Phone: 54 11 4796 8200
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Greenville, South Carolina 29605
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