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)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 July 2021
• Main ID: NCT02370498
• Date of registration: 23/02/2015
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: 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)
• Scientific title: 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
• Date of first enrolment: May 11, 2015
• Target sample size: 592
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02370498
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Canada, Chile, Colombia, Denmark, Estonia, Finland, Germany, Guatemala, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, New Zealand, Norway, Poland, Puerto Rico, Russian Federation, Singapore, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal
junction adenocarcinoma

- Confirmed metastatic or locally advanced, unresectable disease (by computed tomography
[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). As of 20 March 2016, participants must be PD-L1
positive to be enrolled.

- Human epidermal growth factor receptor 2 (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 AEs 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 of (noninfectious) pneumonitis that required steroids or current 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Gastric Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma

Intervention(s)

Biological: pembroliziumab

Drug: paclitaxel

Primary Outcome(s)

Overall Survival (OS) in PD-L1 Positive Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

Secondary Outcome(s)

ORR According to RECIST 1.1 Based on Investigator Assessment in All Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

Percentage of PD-L1 Positive Participants That Discontinued Study Treatment Due to AE [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

Percentage of All Participants Who Experienced an AE [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

Objective Response Rate (ORR) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

DOR According to RECIST 1.1 Based on BICR in All Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

Duration of Response (DOR) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

ORR According to RECIST 1.1 Based on BICR in All Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

TTP According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

TTP According to RECIST 1.1 Based on Investigator Assessment in All Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

DOR According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

ORR According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

DOR According to RECIST 1.1 Based on Investigator Assessment in All Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

PFS According to RECIST 1.1 Based on Investigator Assessment in All Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

Time to Tumor Progression (TTP) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

TTP According to RECIST 1.1 Based on BICR in All Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

OS in All Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

Percentage of All Participants That Discontinued Study Treatment Due to AE [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

Percentage of PD-L1 Positive Participants Who Experienced an Adverse Event (AE) [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

PFS According to Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) Based on BICR in PD-L1 Positive Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

PFS According to irRECIST Based on BICR in All Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

PFS According to RECIST 1.1 Based on BICR in All Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

PFS According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants [Time Frame: Up to 30 months (through database cut-off date of 26 Oct 2017)]

Secondary ID(s)

3475-061

152988

2014-005241-45

MK-3475-061

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/11/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02370498