Epacadostat Before Surgery in Treating Patients With Newly Diagnosed Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 12
Summary
- Conditions
- Stage IIIA Ovarian Cancer AJCC v6 and v7
- Stage III Fallopian Tube Cancer AJCC v7
- Stage III Ovarian Cancer AJCC v6 and v7
- Stage III Primary Peritoneal Cancer AJCC v7
- Stage IIIA Fallopian Tube Cancer AJCC v7
- Stage IIIA Primary Peritoneal Cancer AJCC v7
- Stage IIIB Fallopian Tube Cancer AJCC v7
- Stage IIIB Ovarian Cancer AJCC v6 and v7
- Stage IIIB Primary Peritoneal Cancer AJCC v7
- Stage IV Fallopian Tube Cancer AJCC v6 and v7
- Stage IIIC Fallopian Tube Cancer AJCC v7
- Stage IIIC Ovarian Cancer AJCC v6 and v7
- Stage IIIC Primary Peritoneal Cancer AJCC v7
- Stage IV Ovarian Cancer AJCC v6 and v7
- Stage IV Primary Peritoneal Cancer AJCC v7
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVES: I. To determine the extent by which INCB024360 (epacadostat) alters the number of cluster of differentiation (CD)8+ T cells by immunohistochemistry (IHC). SECONDARY OBJECTIVES: I. To determine the extent by which INCB024360 alters the number and character of tumor infiltrating ly...
PRIMARY OBJECTIVES: I. To determine the extent by which INCB024360 (epacadostat) alters the number of cluster of differentiation (CD)8+ T cells by immunohistochemistry (IHC). SECONDARY OBJECTIVES: I. To determine the extent by which INCB024360 alters the number and character of tumor infiltrating lymphocytes by IHC and gene signature by microarray analysis. II. To determine the extent to which INCB024360 alters the character of the cellular content of peripheral blood mononuclear cells (PBMCs) and ascites fluid as determined by multiparameter flow cytometry. III. To determine the extent to which INCB024360 alters PBMC and ascites fluid transcriptomes. IV. To determine whether INCB024360 alters the ongoing and nascent anti-tumor responses antigens associated with ovarian cancer (e.g., cancer/testis antigen 1B [NY-ESO-1], preferentially expressed antigen in melanoma [PRAME] and mesothelin) as well as memory viral responses (influenza A), and chronic viral responses (cytomegalovirus). V. To assess the safety and tolerability of INCB024360. VI. To determine the extent to which a regimen of INCB024360 that normalizes serum kynurenine/tryptophan (Kyn/Trp) ratios will alter the tumor microenvironment by assessing the ascites and intra-tumor Kyn/Trp ratios at the time of surgery, one day after stopping INCB024360. VII. To associate any observed changes with the expression of IDO1 protein by IHC in tumor or tumor infiltrating cells. OUTLINE: Patients receive epacadostat orally (PO) twice daily (BID) on days 1-14 and undergo surgery on day 15. Treatment continues in the absence of disease progression or unacceptable toxicity. In circumstances where there are medical or administrative reasons for delaying surgery, treatment with epacadostat may continue for up to 3 weeks. After completion of study treatment, patients are followed up for 1 year.
Tracking Information
- NCT #
- NCT02042430
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kunle Odunsi Cancer Immunotherapy Trials Network