Phase 2 Study of Epacadostat (INCB024360) With Pembrolizumab (MK3475) in Metastatic or Unresectable Gastroesophageal Junction and Gastric Adenocarcinoma Requiring Paired Biopsies
This phase 2 trial evaluates the benefit of epacadostat plus pembrolizumab in combination to treat patients with gastroesophageal junction or gastric cancer that has spread to other parts of the body and cannot be removed by surgery. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving epacadostat and pembrolizumab may work better in treating patients with gastroesophageal junction or gastric cancer.
• ≥ 18 years of age on day of consent
• Histologically-or cytologically-confirmed adenocarcinoma of the distal esophagus \[within 5 centimeters of the gastroesophageal junction (GEJ)\], gastroesophageal junction or stomach, including HER2+ disease
• Metastatic or unresectable disease, including those with HER2+ disease
• Progressed on at least 1 line of prior therapy for metastatic disease, or intolerant to that therapy if not progressed
• If HER2+ disease, should have received prior trastuzumab
• Life expectancy ≥ 12 weeks
• Eastern Cooperative Oncology (ECOG) Performance Status 0 or 1
• Measurable disease per RECIST v1.1, assessed within 4 weeks prior to study entry
• Tumor deemed amenable to biopsy by core for metastatic site or endoscopic biopsy for primary tumor (for both before and on-treatment biopsies)
• Able to swallow pills
• Female subject of childbearing potential should have a negative urine or serum pregnancy within 3 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Female subjects of childbearing potential must be willing to use an adequate method of contraception starting with the date of consent through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
• Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the date of consent through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
• Prior authorization by Merck in order to enroll in this study is required if previously treated on any Merck-sponsored pembrolizumab-containing gastric cancer pivotal trial
• Willing to undergo 2 biopsies (before and on-treatment), provided the procedure is not deemed high-risk and is clinically feasible
• Willing and able to provide written informed consent/assent