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Phase 2 N=121 Treatment

Study of Pembrolizumab (MK-3475) in Previously-Treated Participants With Advanced Carcinoma of the Esophagus or Esophagogastric Junction (MK-3475-180/KEYNOTE-180)

Esophageal Carcinoma · Esophagogastric Junction Carcinoma

Enrolled (actual)
121
Serious AEs
38.5%
Results posted
Jul 2019
Primary outcome: Primary: Objective Response Rate (ORR) According to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) — 9.9 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
pembrolizumab (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Merck Sharp & Dohme LLC
Primary completion
Jul 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Objective Response Rate (ORR) According to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR)
9.9
SECONDARY
Number of Participants Who Experienced an Adverse Event (AE)
116
SECONDARY
Number of Participants That Discontinued Study Treatment Due to an AE
14
SECONDARY
Duration of Response (DOR) According to RECIST 1.1 Assessed by BICR
19.7
SECONDARY
Progression Free Survival (PFS) According to RECIST 1.1 Assessed by BICR
2.0
SECONDARY
Overall Survival (OS)
5.8

Summary

In this study participants with advanced/metastatic adenocarcinoma of the esophagus (EAC), squamous cell carcinoma of the esophagus (ESCC), or advanced/metastatic Siewert type I adenocarcinoma of the esophagogastric junction (EGJ), who had been previously treated with two standard therapies, will be treated with pembrolizumab.

Eligibility Criteria

Inclusion Criteria

  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than 3 months
  • Histologically-proven advanced/metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the EGJ
  • Documented objective radiographic or clinical disease progression on two previous lines of standard therapy
  • Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
  • Can provide either a newly obtained or archival tumor tissue sample for intratumoral immune-related testing and for anti-programmed cell death (PD-1)
  • Female participants of childbearing potential must be willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication
  • Male participants must agree to use adequate contraception starting with the first dose through 120 days after the last dose of study medication
  • Adequate organ function

Exclusion Criteria

  • Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study medication
  • Has active autoimmune disease that has required systemic treatment within the 2 years prior to the first dose of study medication
  • 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
  • Known central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Prior anti-cancer mAb, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study medication or not recovered from adverse events due to a previously administered agent
  • Prior therapy with an anti-PD-1, anti-PD-Ligand 1 (PD-L1), or anti-PD-L2 agent, or previously participated in a Merck pembrolizumab (MK-3475) study
  • Has a known additional malignancy that has progressed or required active treatment within the last 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, in-situ cervical cancer, and in-situ or intra-mucosal pharyngeal cancer
  • Received a live vaccine within 30 days of the first dose of study medication
  • Known history of Human Immunodeficiency Virus (HIV) infection
  • Known active Hepatitis B or C
  • History of non-infectious 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 study
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study medication
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02559687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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