Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT03196232|
Recruitment Status : Completed
First Posted : June 22, 2017
Results First Posted : June 22, 2020
Last Update Posted : June 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Recurrent Esophageal Carcinoma Recurrent Gastric Carcinoma Stage IV Esophageal Cancer AJCC v7 Stage IV Gastric Cancer AJCC v7 Unresectable Esophageal Carcinoma||Drug: Epacadostat Drug: Pembrolizumab||Phase 2|
Patients receive epacadostat orally (PO) twice daily (BID) on Days 1 to 21 and pembrolizumab intravenously (IV) over 30 minutes on Day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 9 weeks for 18 months, and then every 12 weeks thereafter.
Assess 6-month progression free survival (PFS).
- To evaluate objective response rate (RR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 and immune-related response criteria (irRC).
- Evaluate overall survival (OS).
- Assess the safety and tolerability of epacadostat in combination with pembrolizumab by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
- Determine the responder rate defined as the proportion of subjects with an increased ratio of CD8+ to Treg cells in on-treatment compared with pre-treatment biopsies.
- Identify putative immunologic biomarkers of tumor response.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Epacadostat (INCB024360) With Pembrolizumab (MK3475) in Metastatic or Unresectable Gastroesophageal Junction and Gastric Adenocarcinoma Requiring Paired Biopsies|
|Actual Study Start Date :||September 13, 2017|
|Actual Primary Completion Date :||May 29, 2018|
|Actual Study Completion Date :||May 29, 2018|
Experimental: Treatment (epacadostat, pembrolizumab)
Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.
- Progression-free Survival (PFS) [ Time Frame: 6 months ]Progression-free survival (PFS) was assessed as the number of participants remaining alive without progression 6 months after beginning treatment. The outcome is reported as a number without dispersion.
- Response Rate [ Time Frame: Up to 6 months ]
Therapeutic response was assessed per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Criteria are:
- Complete Response (CR) = Disappearance of all target lesions
- Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions
- Overall Response (OR) = CR + PR
- Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions
- Stable disease (SD) = Small changes that do not meet any of the above criteria
The outcome is reported as the number of participants with a documented clinical response (ie, either PR or CR) at 6 months after initiation of treatment.
- Overall Survival [ Time Frame: 6 months ]Overall survival (OS) was assessed as the number of participants remaining alive 6 months after beginning treatment. The outcome is reported as a number without dispersion.
- Number of Adverse Events [ Time Frame: Up to 6 months ]Participants were monitored for adverse events. The outcome is reported as the overall number of adverse events of any grade, a number without dispersion.
- Number of Adverse Events ≥ Grade 3 [ Time Frame: Up to 6 months ]Adverse events were assessed per the Common Terminology Criteria for Adverse Events v4.03. The outcome is reported as the number of adverse events ≥ Grade 3, a number without dispersion.
- Treatment Delay or Reduction [ Time Frame: Up to 6 months ]The assessment for clinical value of the treatment combination included treatment delays or reductions, a measure of how well the combination treatment was tolerated. The outcome is reported as the number of participants that experienced a treatment delay, or reduction in treatment dose level, a number without dispersion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196232
|United States, California|
|Stanford University, School of Medicine|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||George A Fisher, MD||Stanford University|