Submitted by: Mary Ann Diaz 2015-11-03 00:00:00 Last Updated by: Michelle Timban Estera 2016-05-05 13:06:58 Export to PDF

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)

PHRR160215-001124

MK-3475-061; CT.gov: NCT02370498

2015-CT0292

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.

In this study, subjects will be randomized to compare the efficacy and safety of pembrolizumab versus paclitaxel. Subjects will be randomized in a 1:1 ratio to receive pembrolizumab or paclitaxel and stratified by geographic region and Eastern Cooperative Oncology Group (ECOG) performance scale.

After a screening phase of up to 28 days, eligible subjects will receive treatment beginning on Day 1 of each 3-week dosing cycle for pembrolizumab or 3 weeks on, 1-week off dosing cycle for paclitaxel.

Treatment with pembrolizumab or paclitaxel will continue until documented disease progression, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, Investigator’s decision to withdraw the subject, subject withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure requirements, subject receives 24 months of pembrolizumab, or administrative reasons requiring cessation of treatment. After the end of treatment, each subject will be followed for 30 days for adverse event monitoring (serious adverse events and events of clinical interest will be collected for 90 days after the end of treatment or 30 days after the end of treatment if the subject initiates new anticancer therapy, whichever is earlier).
Subjects within the pembrolizumab arm who discontinue after 24 months of therapy for reasons other than disease progression or intolerability or who discontinue after attaining a CR may be eligible for up to one year of retreatment after they have experienced radiographic disease progression.
Subjects who discontinue for reasons other than disease progression will have post-treatment follow-up for disease status until disease progression, initiating a non-study cancer treatment, withdrawing consent, or becoming lost to follow-up. All subjects will be followed by telephone for overall survival until death, withdrawal of consent, or the end of the study.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2015-12-18 30 2018-06-18 0000-00-00

Terminated

the enrollment of Asian population is limited to 30% of the overall population (= 174 patients) and PMDA (Health Authority of Japan) requires ~100 patients in Japan. Only ~74 patients can be enrolled in the rest of Asia. Considering current enrollment rat

Institution Classification Region LTO #
Merck Sharp & Dohme (I.A.) LLC Private Business NCR CDRR-NCR-S-16
Institution Amount Region
Merck Sharp & Dohme (I.A.) LLC N/A NCR
Name E-Mail Phone Number Postal Address
Priscila D. Perez priscila.d.perez@merck.com +632 784 9587 26/F Philamlife Tower , 8767 Paseo de Roxas, Makati City, 1226 Philippines
Name E-Mail Phone Number Postal Address
Priscila D. Perez priscila.d.perez@merck.com +632 784 9587 26/F Philamlife Tower , 8767 Paseo de Roxas, Makati City, 1226 Philippines
Name Expertise Affiliation
Ellie May Villegas, MD Internal Medicine – Medical Oncology Perpetual Succour Hospital
Eugenio Emmanuel Regala, MD Internal Medicine – Medical Oncology The Medical City
Maximino De Guzman Bello III, MD Internal Medicine – Medical Oncology St. Luke's Medical Center - Quezon City
Project Location Institutional Ethics Review Board
Perpetual Succour Hospital Perpetual Succour Hospital Institutional Ethics and Review Board
The Medical City The Medical City - Institutional Review Board
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board

- Gastric Adenocarcinoma
- Gastroesophageal Junction Adenocarcinoma

- PFS in PD-L1-positive Participants by Central Radiology Review [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- OS in PD-L1-positive Participants [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

- PFS for All Participants by Central Radiology Review [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- OS in All Participants [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- PFS by Investigator Assessment [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- PFS Using Immune-related Response Assessment by Central Radiology Review [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Time to Tumor Progression (TTP) by Investigator Assessment [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- TTP Using Immune-response Related Assessment by Central Radiology Review [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Overall Response Rate (ORR) by Investigator Assessment [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- ORR Using Immune-related Response Assessment by Central Radiology Review [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Terminated

  • Australia
  • Belgium
  • Chile
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Guatemala
  • Hong Kong
  • Ireland
  • Israel
  • Italy
  • Japan
  • Malaysia
  • New Zealand
  • Norway
  • Philippines
  • Poland
  • Puerto Rico
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey
  • United Kingdom
  • United States

Clinical Trial

20150331160726 and 20150508143950

2015-10-05

None

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

Observational

Unspecified

Unspecified

Randomized

Open Label

Unspecified

Parallel

Treatment

Phase III

7

Unspecified

Screening in Hong Kong, Korea, Malaysia, Philippines, Singapore and Taiwan was closed on 20-Nov-2015. The enrollment of Asian population is limited to 30% of the overall population (174 patients): ~100 patients in Japan, & ~74 patients for rest of Asia.

18 Dec 2015

Utilization Utilization Info
No records found.

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